Eisai Medical Research
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Eisai Medical Research Employees
Employee
Years
Job
Industry
Amie Watts Amie Watts's Eisai Medical Research Experience June 2007 - October 2011
Job Outside Sales Representative at PepsiCo.
Industry Food & Beverages
Experience
Unilever June 2015 - Present
Pepsi Co February 2013 - Present
Eisai Medical Research June 2007 - October 2011
Skills
Pharmaceutical Sales, Account Management, Sales Effectiveness, Pharmaceutical Industry, Cold Calling, Gastroenterology, Sales Presentations, Sales Process, Product Development, Managed Care, Team Building, Selling Skills, Dermatology, Allergy, OB/GYN, Contract Negotiation, New Business Development, Strategic Planning, Customer Service, Marketing, Biotechnology, Healthcare, Market Development, Medical Devices, Product Launch, Sales, Sales Management, Selling, Urology, Sales Operations
Education
University of Central Oklahoma 1994 — 1999
Unilever June 2015 - Present
Pepsi Co February 2013 - Present
Eisai Medical Research June 2007 - October 2011
Skills
Pharmaceutical Sales, Account Management, Sales Effectiveness, Pharmaceutical Industry, Cold Calling, Gastroenterology, Sales Presentations, Sales Process, Product Development, Managed Care, Team Building, Selling Skills, Dermatology, Allergy, OB/GYN, Contract Negotiation, New Business Development, Strategic Planning, Customer Service, Marketing, Biotechnology, Healthcare, Market Development, Medical Devices, Product Launch, Sales, Sales Management, Selling, Urology, Sales Operations
Education
University of Central Oklahoma 1994 — 1999
Junhong Zhu Junhong Zhu's Eisai Medical Research Experience January 2010 - April 2011
Job Associate Director, Biostatistics at Bayer HealthCare
Industry Pharmaceuticals
Experience
Bayer HealthCare December 2012 - Present
LifeScan of J&J December 2011 - December 2012
K&L Consulting Services, Inc. May 2011 - November 2012
Eisai Medical Research January 2010 - April 2011
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2007 - December 2009
Organon Pharmaceuticals August 2002 - December 2006
St. Jude Children's Research Hospital May 1998 - August 2002
Skills
Clinical Development, Biostatistics, Clinical Trials, CRO, CDISC, Clinical Data Management, Clinical Study Design, EDC, SAS programming, Survival Analysis, Drug Development, SAS, SDTM, Statistical Programming, Oncology, Pharmaceutical Industry, SAS Programming, GCP
Education
The University of Memphis
Doctor of Philosophy (Ph.D.), Statistics
Northwestern Polytechnic University (CN)
Master of Science (M.S.)
Tsinghua University
Bachelor of Engineering (B.E.)
Bayer HealthCare December 2012 - Present
LifeScan of J&J December 2011 - December 2012
K&L Consulting Services, Inc. May 2011 - November 2012
Eisai Medical Research January 2010 - April 2011
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2007 - December 2009
Organon Pharmaceuticals August 2002 - December 2006
St. Jude Children's Research Hospital May 1998 - August 2002
Skills
Clinical Development, Biostatistics, Clinical Trials, CRO, CDISC, Clinical Data Management, Clinical Study Design, EDC, SAS programming, Survival Analysis, Drug Development, SAS, SDTM, Statistical Programming, Oncology, Pharmaceutical Industry, SAS Programming, GCP
Education
The University of Memphis
Doctor of Philosophy (Ph.D.), Statistics
Northwestern Polytechnic University (CN)
Master of Science (M.S.)
Tsinghua University
Bachelor of Engineering (B.E.)
Arthur Mate Arthur Mate's Eisai Medical Research Experience April 2000 - April 2007
Job Associate Director at Celgene
Industry Pharmaceuticals
Experience
Celgene April 2007 - Present
Eisai Medical Research April 2000 - April 2007
Roche September 1985 - March 2000
Skills
GxP, Computer System..., Validation, Pharmaceuticals, Compliance, Quality Auditing, Vendor Audit, Auditing, Laboratory audits, vendor oversight, Process Improvement
Education
Montclair State University 1995 — 2000
MBA, Business
UMDNJ 1984 — 1985
Medical Technology, MT (ASCP)
Celgene April 2007 - Present
Eisai Medical Research April 2000 - April 2007
Roche September 1985 - March 2000
Skills
GxP, Computer System..., Validation, Pharmaceuticals, Compliance, Quality Auditing, Vendor Audit, Auditing, Laboratory audits, vendor oversight, Process Improvement
Education
Montclair State University 1995 — 2000
MBA, Business
UMDNJ 1984 — 1985
Medical Technology, MT (ASCP)
Marc Yellin Marc Yellin's Eisai Medical Research Experience October 2005 - July 2008
Job AwardWinning Blogger & Webmaster
Industry Online Media
Experience
Abq Jew LLC November 2010 - Present
Tigerdog Communications LLC July 2008 - Present
Merck October 2008 - May 2010
Eisai Medical Research October 2005 - July 2008
Schering Plough November 2004 - September 2005
Lucent Technologies May 1996 - November 2002
Intel July 1987 - June 1993
Skills
Judaism, Blogging, Writing, Hebrew, Books, Banjo, Bluegrass, Creative Writing, Website Development, Web Design, Web Content, Technical Writing, Editing, Newsletters, Project Planning, Software Documentation, Quality Assurance, Project Management, Listening to Music, Reading, Thinking Outside The Box, Process Improvement, Content Management, Music, Adobe Acrobat, Content Development, Publications, Social Networking, Content Strategy, Copy Editing, Publishing, Advertising, Freelance Writing, Copywriting, Editorial, Journalism, SEO, Press Releases, Proofreading, Facebook, Newspapers, Proposal Writing, Online Marketing, Storytelling, Magazines, New Media, Corporate Communications, History, Email Marketing, Media Relations
Education
Jewish Theological Seminary of America 1974 — 1978
M.A.
University of California, Los Angeles 1971 — 1972
B.S.
Technion - Israel Institute of Technology 1970 — 1971
University of California, Davis 1968 — 1970
Abq Jew LLC November 2010 - Present
Tigerdog Communications LLC July 2008 - Present
Merck October 2008 - May 2010
Eisai Medical Research October 2005 - July 2008
Schering Plough November 2004 - September 2005
Lucent Technologies May 1996 - November 2002
Intel July 1987 - June 1993
Skills
Judaism, Blogging, Writing, Hebrew, Books, Banjo, Bluegrass, Creative Writing, Website Development, Web Design, Web Content, Technical Writing, Editing, Newsletters, Project Planning, Software Documentation, Quality Assurance, Project Management, Listening to Music, Reading, Thinking Outside The Box, Process Improvement, Content Management, Music, Adobe Acrobat, Content Development, Publications, Social Networking, Content Strategy, Copy Editing, Publishing, Advertising, Freelance Writing, Copywriting, Editorial, Journalism, SEO, Press Releases, Proofreading, Facebook, Newspapers, Proposal Writing, Online Marketing, Storytelling, Magazines, New Media, Corporate Communications, History, Email Marketing, Media Relations
Education
Jewish Theological Seminary of America 1974 — 1978
M.A.
University of California, Los Angeles 1971 — 1972
B.S.
Technion - Israel Institute of Technology 1970 — 1971
University of California, Davis 1968 — 1970
Jennifer Biondi Jennifer Biondi's Eisai Medical Research Experience January 1999 - August 2004
Job Human Resources Coordinator
Industry Human Resources
Experience
INTTRA 2014 - June 2015
CKA Management (formerly Vale Management Corp.) March 2011 - June 2014
Eisai Medical Research January 1999 - August 2004
Education
University of North Carolina at Charlotte 1988 — 1993
Bachelor of Science (B.S.), Biology/Psychology
INTTRA 2014 - June 2015
CKA Management (formerly Vale Management Corp.) March 2011 - June 2014
Eisai Medical Research January 1999 - August 2004
Education
University of North Carolina at Charlotte 1988 — 1993
Bachelor of Science (B.S.), Biology/Psychology
Kristen Levis's Eisai Medical Research Experience 2003 - 2007
Job Project Management, Sales, Contract Negotiation & Outsourcing (Pharmaceuticals & Consumer Products)
Industry Pharmaceuticals
Experience
Bayer HealthCare January 2015 - Present
Skinplicity 2007 - 2014
Bluemercury 2012 - 2013
Celgene 2007 - 2012
Eisai Medical Research 2003 - 2007
Skills
Project Management, Pharmaceutical Industry, Team Building, Operations Management, Vendor Management, Strategic Planning, Process Improvement, Cross-functional Team..., Program Management, Strategy, Training, Management
Education
Fashion Institute of Technology 2009 — 2015
Masters, Marketing & Management
Artistic Academy 2012 — 2012
Esthetics & Make Up Artistry, Aesthetician/Esthetician and Skin Care Specialist
University of Rhode Island 1999 — 2003
BA, Public Relations
University of Melbourne 2001 — 2002
BA, Public Relations/Marketing
Bayer HealthCare January 2015 - Present
Skinplicity 2007 - 2014
Bluemercury 2012 - 2013
Celgene 2007 - 2012
Eisai Medical Research 2003 - 2007
Skills
Project Management, Pharmaceutical Industry, Team Building, Operations Management, Vendor Management, Strategic Planning, Process Improvement, Cross-functional Team..., Program Management, Strategy, Training, Management
Education
Fashion Institute of Technology 2009 — 2015
Masters, Marketing & Management
Artistic Academy 2012 — 2012
Esthetics & Make Up Artistry, Aesthetician/Esthetician and Skin Care Specialist
University of Rhode Island 1999 — 2003
BA, Public Relations
University of Melbourne 2001 — 2002
BA, Public Relations/Marketing
claudia stanciu claudia stanciu's Eisai Medical Research Experience April 2013 - Present
Job Sr. Quality Auditor at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research April 2013 - Present
Roche July 2012 - April 2013
Novo Nordisk January 2012 - July 2012
Apotex Inc. May 2011 - December 2011
Hospira August 2010 - July 2011
Sandoz May 2010 - August 2010
BD January 2009 - May 2010
Novartis August 2008 - January 2010
bioMerieux January 2007 - February 2009
Laboratoire Boiron March 2006 - February 2008
Skills
21 CFR Part 11, FDA, Sop, GxP, Change Control, Validation, GMP, CAPA, Quality System, Quality Assurance, GLP, Regulatory Affairs
Education
University of North Carolina at Chapel Hill 2012 — 2016
PhD Pharmaceutical Sciences, Pharmaceutical Sciences, NA
Temple University 2000 — 2003
Quality Assurance Regulaatory Affairs Program, Pharmaceutical Sciences, 3.6
Temple University 1990 — 1995
Bachlor of Science, Engineering Chemistry, 3.4
Eisai Medical Research April 2013 - Present
Roche July 2012 - April 2013
Novo Nordisk January 2012 - July 2012
Apotex Inc. May 2011 - December 2011
Hospira August 2010 - July 2011
Sandoz May 2010 - August 2010
BD January 2009 - May 2010
Novartis August 2008 - January 2010
bioMerieux January 2007 - February 2009
Laboratoire Boiron March 2006 - February 2008
Skills
21 CFR Part 11, FDA, Sop, GxP, Change Control, Validation, GMP, CAPA, Quality System, Quality Assurance, GLP, Regulatory Affairs
Education
University of North Carolina at Chapel Hill 2012 — 2016
PhD Pharmaceutical Sciences, Pharmaceutical Sciences, NA
Temple University 2000 — 2003
Quality Assurance Regulaatory Affairs Program, Pharmaceutical Sciences, 3.6
Temple University 1990 — 1995
Bachlor of Science, Engineering Chemistry, 3.4
Ragini Hari's Eisai Medical Research Experience November 2008 - March 2009
Job Sr Manager, Programming Biostatistics at PPD
Industry Pharmaceuticals
Experience
PPD March 2015 - Present
PPD 2013 - Present
UCB Biosciences 2010 - 2012
Schwarz Biosciences (A member of UCB group of companies) June 2009 - October 2010
Eisai Medical Research November 2008 - March 2009
UCB Pharma February 2004 - October 2008
Makro tech 2001 - 2004
Skills
CDISC, SAS programming, Data Management, Data Mining, Clinical Research, Clinical Trials, NDA submissions, Project Management, Team Management, Multi-cultural..., Leadership, Process Control, OC RDC, CRF design, Protocol Review, CRF annotations, SDTM, SAS, CTMS, Clinical Development, CRO, Clinical Data Management, Oracle Clinical, FDA, GCP, 21 CFR Part 11, SAS Programming
Education
University of Missouri-Rolla 2001 — 2003
MS in Comp Sci, Research Thesis in Data Mining
Jawaharlal Nehru Technological University 1997 — 2001
BTech, Computer Science & IT
PPD March 2015 - Present
PPD 2013 - Present
UCB Biosciences 2010 - 2012
Schwarz Biosciences (A member of UCB group of companies) June 2009 - October 2010
Eisai Medical Research November 2008 - March 2009
UCB Pharma February 2004 - October 2008
Makro tech 2001 - 2004
Skills
CDISC, SAS programming, Data Management, Data Mining, Clinical Research, Clinical Trials, NDA submissions, Project Management, Team Management, Multi-cultural..., Leadership, Process Control, OC RDC, CRF design, Protocol Review, CRF annotations, SDTM, SAS, CTMS, Clinical Development, CRO, Clinical Data Management, Oracle Clinical, FDA, GCP, 21 CFR Part 11, SAS Programming
Education
University of Missouri-Rolla 2001 — 2003
MS in Comp Sci, Research Thesis in Data Mining
Jawaharlal Nehru Technological University 1997 — 2001
BTech, Computer Science & IT
Satish Hemadri Satish Hemadri's Eisai Medical Research Experience October 2012 - December 2013
Job Senior SAS Programming Consultant at Parexel
Industry Information Technology and Services
Experience
PAREXEL July 2014 - Present
Accenture December 2013 - July 2014
Eisai Medical Research October 2012 - December 2013
Pfizer January 2009 - October 2012
Mahindra Satyam May 2007 - October 2012
Cognizant Technology Solutions 2006 - 2007
TCS 2003 - 2006
Skills
Project Management, Data Analysis, Data Warehousing, Data Modeling, ETL, EDC, Business Analytics, Informatica, PMP, PL/SQL, Vendor Management, Resource Management, Global Delivery, SQL, Databases, CDISC, Oracle Clinical, Unix Shell Scripting, Software Development, GCP, Lifesciences, ICH-GCP, Integration, Unix, Clinical Development, Oncology, Computer System..., Life Sciences
Education
Gulbarga University 1993 — 1997
B.Pharm, Pharmacy
IDPL High School 1990 — 1990
10 Class
Gulbarga University
PAREXEL July 2014 - Present
Accenture December 2013 - July 2014
Eisai Medical Research October 2012 - December 2013
Pfizer January 2009 - October 2012
Mahindra Satyam May 2007 - October 2012
Cognizant Technology Solutions 2006 - 2007
TCS 2003 - 2006
Skills
Project Management, Data Analysis, Data Warehousing, Data Modeling, ETL, EDC, Business Analytics, Informatica, PMP, PL/SQL, Vendor Management, Resource Management, Global Delivery, SQL, Databases, CDISC, Oracle Clinical, Unix Shell Scripting, Software Development, GCP, Lifesciences, ICH-GCP, Integration, Unix, Clinical Development, Oncology, Computer System..., Life Sciences
Education
Gulbarga University 1993 — 1997
B.Pharm, Pharmacy
IDPL High School 1990 — 1990
10 Class
Gulbarga University
Maria Meyers Maria Meyers's Eisai Medical Research Experience July 2014 - Present
Job Sr. Manager, Clinical Operations, Eisai
Industry Pharmaceuticals
Experience
Eisai Medical Research July 2014 - Present
Eisai November 2013 - July 2014
Skills
Drug Development, Clinical Operations, Clinical Trials, Clinical Development, Pharmaceutical Industry, CRO, CTMS, GCP, EDC, Regulatory Submissions, ICH-GCP
Education
Temple University 2005 — 2010
Master's degree, Regulatory Affairs / Quality Assurance, 4.0
The Catholic University of America 1989 — 1993
Bachelor of Science (B.Sc.), Biology, General
Eisai Medical Research July 2014 - Present
Eisai November 2013 - July 2014
Skills
Drug Development, Clinical Operations, Clinical Trials, Clinical Development, Pharmaceutical Industry, CRO, CTMS, GCP, EDC, Regulatory Submissions, ICH-GCP
Education
Temple University 2005 — 2010
Master's degree, Regulatory Affairs / Quality Assurance, 4.0
The Catholic University of America 1989 — 1993
Bachelor of Science (B.Sc.), Biology, General
Dale Ordemann Dale Ordemann's Eisai Medical Research Experience 2002 - September 2008
Job Program Manager at Otsuka
Industry Pharmaceuticals
Experience
Otsuka Pharmaceutical Development & Commercialization July 2012 - Present
Eisai Inc. October 2008 - May 2012
Eisai Medical Research 2002 - September 2008
Purepac Pharmaceuticals December 1999 - June 2002
Alpharma 1999 - 2002
Ciba-Geigy/Novartis 1990 - 1999
Skills
Project Management, Program Management, Project Portfolio..., Project Planning, Business Operations, Operating Budgets, Contract Management, Vendor Management, Contract Negotiation, Clinical Trials, Oncology, Drug Development, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, GCP, Regulatory Submissions, Lifesciences, R&D, Pharmacovigilance, CTMS, GMP, Regulatory Affairs, Biotechnology, CRO, FDA, Pharmaceutics, Sop, Cross-functional Team..., IND, Biopharmaceuticals
Education
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Biology, General
Rutgers, The State University of New Jersey-New Brunswick
M.S., Zoology
Otsuka Pharmaceutical Development & Commercialization July 2012 - Present
Eisai Inc. October 2008 - May 2012
Eisai Medical Research 2002 - September 2008
Purepac Pharmaceuticals December 1999 - June 2002
Alpharma 1999 - 2002
Ciba-Geigy/Novartis 1990 - 1999
Skills
Project Management, Program Management, Project Portfolio..., Project Planning, Business Operations, Operating Budgets, Contract Management, Vendor Management, Contract Negotiation, Clinical Trials, Oncology, Drug Development, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, GCP, Regulatory Submissions, Lifesciences, R&D, Pharmacovigilance, CTMS, GMP, Regulatory Affairs, Biotechnology, CRO, FDA, Pharmaceutics, Sop, Cross-functional Team..., IND, Biopharmaceuticals
Education
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Biology, General
Rutgers, The State University of New Jersey-New Brunswick
M.S., Zoology
Damon Thomas Daulerio Damon Thomas Daulerio's Eisai Medical Research Experience January 2003 - August 2005
Job Regulatory Associate Director at Boehringer Ingelheim Pharmaceuticals
Industry Pharmaceuticals
Experience
Boehringer Ingelheim Pharmaceuticals August 2005 - Present
Eisai Medical Research January 2003 - August 2005
Education
Fairfield University 2001 — 2003
Master of Business Administration (MBA), International Business
Fairfield University 1993 — 1996
Bachelor of Science (BS), Biology, General
Boehringer Ingelheim Pharmaceuticals August 2005 - Present
Eisai Medical Research January 2003 - August 2005
Education
Fairfield University 2001 — 2003
Master of Business Administration (MBA), International Business
Fairfield University 1993 — 1996
Bachelor of Science (BS), Biology, General
Saundra Wells-Davis Saundra Wells-Davis's Eisai Medical Research Experience April 2003 - September 2011
Job Professional Sales Represenatative at Golden LivingCenters
Industry Pharmaceuticals
Experience
Golden LivingCenters February 2014 - Present
Maximum Home Health August 2013 - Present
Eisai Medical Research April 2003 - September 2011
AstraZeneca 1999 - 2002
Skills
Neurology, Cardiology, Internal Medicine, Psychiatry, Pharmaceutical Sales, Gastroenterology, Healthcare, Pharmaceuticals, Customer Relations, Budgeting, Microsoft Office, Territory, Excel, PowerPoint, Business Strategy, Word, Outlook
Education
Tuskegee University 1983 — 1987
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Golden LivingCenters February 2014 - Present
Maximum Home Health August 2013 - Present
Eisai Medical Research April 2003 - September 2011
AstraZeneca 1999 - 2002
Skills
Neurology, Cardiology, Internal Medicine, Psychiatry, Pharmaceutical Sales, Gastroenterology, Healthcare, Pharmaceuticals, Customer Relations, Budgeting, Microsoft Office, Territory, Excel, PowerPoint, Business Strategy, Word, Outlook
Education
Tuskegee University 1983 — 1987
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Paul Fink Paul Fink's Eisai Medical Research Experience January 2013 - Present
Job MRO Inventory Control Specilist at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research January 2013 - Present
ARAUCO January 2009 - December 2012
Select Telcomm Inc. January 2005 - January 2008
Skills
Strategic Sourcing, SAP, Inventory Control, Supply Chain, MRP, Cross-functional Team..., Six Sigma, Production Planning, Materials Management, 5S, Supply Chain..., ISO, Process Improvement, Kaizen, Supply Chain Management, GMP, Validation
Education
Central Carolina Community College
Telecommunications Technology/Technician
Eisai Medical Research January 2013 - Present
ARAUCO January 2009 - December 2012
Select Telcomm Inc. January 2005 - January 2008
Skills
Strategic Sourcing, SAP, Inventory Control, Supply Chain, MRP, Cross-functional Team..., Six Sigma, Production Planning, Materials Management, 5S, Supply Chain..., ISO, Process Improvement, Kaizen, Supply Chain Management, GMP, Validation
Education
Central Carolina Community College
Telecommunications Technology/Technician
Andrew Eisen, MD, PhD Andrew Eisen, MD, PhD's Eisai Medical Research Experience January 2008 - May 2011
Job Senior Director, Translational Medicine at Acorda Therapeutics
Industry Pharmaceuticals
Experience
Acorda Therapeutics May 2012 - Present
AVA 2002 - 2013
Translational Medicine Strategies May 2011 - May 2012
Eisai Medical Research January 2008 - May 2011
Daiichi-Sankyo 2005 - 2008
CurGen 1999 - 2004
Albert Einstein College of Medicine 1989 - 1998
Skills
Drug Discovery, Clinical Development, Clinical Research, Clinical Trials, Translational Research, Biomarkers, Pharmacodynamics, Pediatrics, Genetics, Metabolic Diseases, Oncology, Life Sciences, Biotechnology, Molecular Biology, Biochemistry, Pharmacogenomics, Proteomics, Genomics
Education
University of Pennsylvania School of Medicine 1976 — 1982
MD, PhD, Medicine & Biophysics
Princeton University
Acorda Therapeutics May 2012 - Present
AVA 2002 - 2013
Translational Medicine Strategies May 2011 - May 2012
Eisai Medical Research January 2008 - May 2011
Daiichi-Sankyo 2005 - 2008
CurGen 1999 - 2004
Albert Einstein College of Medicine 1989 - 1998
Skills
Drug Discovery, Clinical Development, Clinical Research, Clinical Trials, Translational Research, Biomarkers, Pharmacodynamics, Pediatrics, Genetics, Metabolic Diseases, Oncology, Life Sciences, Biotechnology, Molecular Biology, Biochemistry, Pharmacogenomics, Proteomics, Genomics
Education
University of Pennsylvania School of Medicine 1976 — 1982
MD, PhD, Medicine & Biophysics
Princeton University
Mark Friesen Mark Friesen's Eisai Medical Research Experience December 2002 - March 2004
Job Director, Project Managent at SK Life Science
Industry Pharmaceuticals
Experience
SK Life Science, Inc January 2015 - Present
SK Life Science, Inc. September 2011 - January 2015
Merck (formerly Schering-Plough Pharmaceuticals) November 2006 - September 2011
Abbott Laboratories March 2004 - November 2006
Eisai Medical Research December 2002 - March 2004
GoAmerica Communications January 2001 - December 2002
GoAmerica Communications 2001 - 2002
Knoll Pharmaceutical Corporation November 1999 - January 2001
Skills
Program Management, Cross-functional Team..., Pharmaceutical Industry, Oncology, Vendor Management, Project Portfolio..., MS Project, Project Planning, Clinical Development, Drug Development, FDA, Product Development, Project Management, Biotechnology, Process Improvement, Contract Negotiation, PMP, Regulatory Affairs, Regulatory Submissions, GMP, Marketing, Clinical Trials, Sop, 21 CFR Part 11
Education
Rutgers University-New Brunswick
BS, Chemistry, Food & Nutrition
Stevens Institute of Technology
MTM, Masters of Technology Management
SK Life Science, Inc January 2015 - Present
SK Life Science, Inc. September 2011 - January 2015
Merck (formerly Schering-Plough Pharmaceuticals) November 2006 - September 2011
Abbott Laboratories March 2004 - November 2006
Eisai Medical Research December 2002 - March 2004
GoAmerica Communications January 2001 - December 2002
GoAmerica Communications 2001 - 2002
Knoll Pharmaceutical Corporation November 1999 - January 2001
Skills
Program Management, Cross-functional Team..., Pharmaceutical Industry, Oncology, Vendor Management, Project Portfolio..., MS Project, Project Planning, Clinical Development, Drug Development, FDA, Product Development, Project Management, Biotechnology, Process Improvement, Contract Negotiation, PMP, Regulatory Affairs, Regulatory Submissions, GMP, Marketing, Clinical Trials, Sop, 21 CFR Part 11
Education
Rutgers University-New Brunswick
BS, Chemistry, Food & Nutrition
Stevens Institute of Technology
MTM, Masters of Technology Management
Ganesh Appavoo Ganesh Appavoo's Eisai Medical Research Experience January 2007 - January 2008
Job Network Engineer at BMC Software
Industry Information Technology and Services
Experience
BMC Software October 2010 - Present
AT&T July 2008 - December 2010
HP February 2008 - June 2008
Eisai Medical Research January 2007 - January 2008
IBM Global Services January 2004 - December 2006
ITC Ltd February 2002 - November 2003
Education
Madurai Kamaraj University 1997 — 2000
BCOM, Commerce
BMC Software October 2010 - Present
AT&T July 2008 - December 2010
HP February 2008 - June 2008
Eisai Medical Research January 2007 - January 2008
IBM Global Services January 2004 - December 2006
ITC Ltd February 2002 - November 2003
Education
Madurai Kamaraj University 1997 — 2000
BCOM, Commerce
Laura Zumpano Laura Zumpano's Eisai Medical Research Experience August 2008 - February 2011
Job Director, Clinical Operations Program Lead at Pfizer
Industry Pharmaceuticals
Experience
Pfizer April 2014 - Present
Pfizer December 2010 - March 2014
Pfizer Pharmaceuticals December 2010 - January 2012
Eisai Medical Research August 2008 - February 2011
Novartis August 2006 - April 2008
Pfizer February 2001 - August 2006
PharmaNet January 2000 - November 2000
ISCL 1997 - 1999
Hoechst Marion Roussel/Hoechst Roussel Pharmaceuticals 1993 - 1997
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, Clinical Development, CRO, Oncology, Drug Development, Neurology, Protocol, GCP, EDC, Biotechnology, Vaccines, CTMS, TMF, Clinical Operations, Pharmacovigilance, Therapeutic Areas, Medical Affairs
Education
American Yoga Academy 2013 — 2013
Certified Yoga Instructor, RYT 300 hours completed for 200 hour certificate, Hatha and Vinyasa Yoga
Union County College 2005 — 2010
Rutgers University-New Brunswick 1985 — 1989
Psychopharmacology and French
Pfizer April 2014 - Present
Pfizer December 2010 - March 2014
Pfizer Pharmaceuticals December 2010 - January 2012
Eisai Medical Research August 2008 - February 2011
Novartis August 2006 - April 2008
Pfizer February 2001 - August 2006
PharmaNet January 2000 - November 2000
ISCL 1997 - 1999
Hoechst Marion Roussel/Hoechst Roussel Pharmaceuticals 1993 - 1997
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, Clinical Development, CRO, Oncology, Drug Development, Neurology, Protocol, GCP, EDC, Biotechnology, Vaccines, CTMS, TMF, Clinical Operations, Pharmacovigilance, Therapeutic Areas, Medical Affairs
Education
American Yoga Academy 2013 — 2013
Certified Yoga Instructor, RYT 300 hours completed for 200 hour certificate, Hatha and Vinyasa Yoga
Union County College 2005 — 2010
Rutgers University-New Brunswick 1985 — 1989
Psychopharmacology and French
Gretchen Griffin Gretchen Griffin's Eisai Medical Research Experience June 2005 - March 2009
Job Director, Regulatory Writing at AbbVie
Industry Pharmaceuticals
Experience
AbbVie April 2015 - Present
Pharma Start January 2014 - April 2015
MedImmune March 2009 - January 2014
Eisai Medical Research June 2005 - March 2009
Allergan Pharmaceuticals February 2004 - June 2005
Schering-Plough 1997 - 2004
Schering-Plough Research Institute 1997 - 2004
Skills
Clinical Development, Medical Writing, Regulatory Affairs, Toxicology, Regulatory Submissions, Oncology, Pharmaceutical Industry, IND, Clinical Trials, GCP, Biotechnology, Lifesciences, CRO, Clinical Research, FDA, Sop, Drug Development, Therapeutic Areas, Scientific Writing, GLP, Vaccines, Protocol, Infectious Diseases
Education
The Johns Hopkins University 2010 — 2014
Masters of Science, Regulatory Science
University of the Sciences in Philadelphia 2006 — 2010
Regulatory Writing Certificate Program, Biomedical Writing
Rutgers University-New Brunswick 1995 — 1997
Bachelors of Science, Animal Science with a concentration in Pre-Veterinary Medicine
AMWA Annual Conference
Delaware Valley College
AbbVie April 2015 - Present
Pharma Start January 2014 - April 2015
MedImmune March 2009 - January 2014
Eisai Medical Research June 2005 - March 2009
Allergan Pharmaceuticals February 2004 - June 2005
Schering-Plough 1997 - 2004
Schering-Plough Research Institute 1997 - 2004
Skills
Clinical Development, Medical Writing, Regulatory Affairs, Toxicology, Regulatory Submissions, Oncology, Pharmaceutical Industry, IND, Clinical Trials, GCP, Biotechnology, Lifesciences, CRO, Clinical Research, FDA, Sop, Drug Development, Therapeutic Areas, Scientific Writing, GLP, Vaccines, Protocol, Infectious Diseases
Education
The Johns Hopkins University 2010 — 2014
Masters of Science, Regulatory Science
University of the Sciences in Philadelphia 2006 — 2010
Regulatory Writing Certificate Program, Biomedical Writing
Rutgers University-New Brunswick 1995 — 1997
Bachelors of Science, Animal Science with a concentration in Pre-Veterinary Medicine
AMWA Annual Conference
Delaware Valley College
Tita (Jeter) Simmons, MSQR, RAC, CSSBB, CQM Tita (Jeter) Simmons, MSQR, RAC, CSSBB, CQM's Eisai Medical Research Experience May 2002 - December 2003
Job Senior Director, Global Quality, Regulatory Affairs & Operational Excellence
Industry Pharmaceuticals
Experience
Health Decisions January 2014 - Present
Health Decisions August 2012 - January 2014
Health Decisions March 2012 - August 2012
Copernicus Group IRB June 2011 - March 2012
Copernicus Group IRB June 2010 - June 2011
Duke University Medical Center July 2008 - June 2010
PPD July 2007 - July 2008
Encysive Pharmaceuticals July 2004 - June 2007
i3 Research 2003 - 2004
Eisai Medical Research May 2002 - December 2003
Skills
Continuous Improvement, Quality Management, Auditing, ISO, Quality Systems, Six Sigma, Kaizen, Process Improvement, Risk Management, Lean Sigma, Compliance Management, Regulatory Affairs, Regulatory Submissions, Quality System, FDA, GCP, Sop, ISO 13485, Clinical Research, Validation, Quality Assurance, Pharmaceutical Industry, GLP, Clinical Trials, EDC, 21 CFR Part 11, CRO, Software Documentation, CAPA, Cross-functional Team..., GMP, GxP, Quality Control, Clinical Development, CTMS, Biotechnology, Change Control, Quality Auditing, Medical Devices, Regulatory Requirements
Education
Temple Graduate School of Pharmacy 2003 — 2006
MS
Kean University 1992 — 2002
BS
Health Decisions January 2014 - Present
Health Decisions August 2012 - January 2014
Health Decisions March 2012 - August 2012
Copernicus Group IRB June 2011 - March 2012
Copernicus Group IRB June 2010 - June 2011
Duke University Medical Center July 2008 - June 2010
PPD July 2007 - July 2008
Encysive Pharmaceuticals July 2004 - June 2007
i3 Research 2003 - 2004
Eisai Medical Research May 2002 - December 2003
Skills
Continuous Improvement, Quality Management, Auditing, ISO, Quality Systems, Six Sigma, Kaizen, Process Improvement, Risk Management, Lean Sigma, Compliance Management, Regulatory Affairs, Regulatory Submissions, Quality System, FDA, GCP, Sop, ISO 13485, Clinical Research, Validation, Quality Assurance, Pharmaceutical Industry, GLP, Clinical Trials, EDC, 21 CFR Part 11, CRO, Software Documentation, CAPA, Cross-functional Team..., GMP, GxP, Quality Control, Clinical Development, CTMS, Biotechnology, Change Control, Quality Auditing, Medical Devices, Regulatory Requirements
Education
Temple Graduate School of Pharmacy 2003 — 2006
MS
Kean University 1992 — 2002
BS
Darren Providence, MSIS, PMP Darren Providence, MSIS, PMP's Eisai Medical Research Experience May 2007 - May 2008
Job Director, IT Project Management Office at Morehouse School of Medicine
Industry Hospital & Health Care
Experience
Morehouse School of Medicine April 2011 - Present
Kaiser Permanente June 2009 - April 2011
Eisai Medical Research May 2007 - May 2008
Wyeth Pharmaceuticals 2000 - 2007
Computer Associates International January 1998 - March 2000
Prudential Healthcare January 1997 - January 1998
U.S. Army 1987 - 1997
Education
Stevens Institute of Technology
MS
Norfolk State University
BS
Project Management Institute
PMP
Morehouse School of Medicine April 2011 - Present
Kaiser Permanente June 2009 - April 2011
Eisai Medical Research May 2007 - May 2008
Wyeth Pharmaceuticals 2000 - 2007
Computer Associates International January 1998 - March 2000
Prudential Healthcare January 1997 - January 1998
U.S. Army 1987 - 1997
Education
Stevens Institute of Technology
MS
Norfolk State University
BS
Project Management Institute
PMP
Kunjal Shah Kunjal Shah's Eisai Medical Research Experience December 2008 - March 2009
Job Contracts Analyst at inVentiv Clinical
Industry Pharmaceuticals
Experience
inVentiv Health April 2014 - Present
Covance April 2013 - April 2014
Covance July 2012 - April 2013
PTC Therapeutics August 2010 - July 2012
Bloomberg October 2009 - August 2010
Eisai Medical Research December 2008 - March 2009
TKL Research July 2007 - December 2008
Deloitte May 2006 - April 2007
Expeditors International February 2004 - April 2006
Skills
Financial Reporting, Strategic Planning, Excel, PowerPoint, Microsoft Excel, Analysis, Risk Management, Budgets, Forecasting, Management, Auditing, Quality Assurance, Process Improvement, Business Development, Data Analysis, Finance, Project Planning
Education
Pace University - Lubin School of Business 2001 — 2004
Bachelor of Business Administration, Business Economics
inVentiv Health April 2014 - Present
Covance April 2013 - April 2014
Covance July 2012 - April 2013
PTC Therapeutics August 2010 - July 2012
Bloomberg October 2009 - August 2010
Eisai Medical Research December 2008 - March 2009
TKL Research July 2007 - December 2008
Deloitte May 2006 - April 2007
Expeditors International February 2004 - April 2006
Skills
Financial Reporting, Strategic Planning, Excel, PowerPoint, Microsoft Excel, Analysis, Risk Management, Budgets, Forecasting, Management, Auditing, Quality Assurance, Process Improvement, Business Development, Data Analysis, Finance, Project Planning
Education
Pace University - Lubin School of Business 2001 — 2004
Bachelor of Business Administration, Business Economics
Anthony Suarez's Eisai Medical Research Experience 2004 - 2005
Job Head of Engineering Amazon EC2 Container Service
Industry Information Technology and Services
Experience
Amazon Web Services 2014 - Present
Amazon Web Services 2012 - 2014
Stryker 2005 - 2012
GRIDPEAK, LLC 1998 - 2012
Eisai Medical Research 2004 - 2005
WTBTS 1998 - 2004
The College of Westchester 1996 - 1998
Skills
Strategy, Infrastructure..., Cloud Computing, IaaS, Enterprise Architecture, Leadership, Microsoft Operating..., VMware Infrastructure, Citrix, SharePoint, Network Design, VMware, Amazon Web Services..., Servers, Enterprise Software, Scalability, Disaster Recovery, Virtualization, Infrastructure, IT Operations, Microsoft Exchange, Data Center, Technical Support, System Architecture, Windows Server, Software Development, Architecture, System Administration, Windows, High Availability, Integration, System Deployment, Microsoft Technologies, IT Management, Web Services, IT Strategy, Storage Area Networks, Storage, SaaS, Computer Security, IIS, Solution Architecture, DNS, VMware ESX, ITIL, Server Architecture, SAN, IT Service Management, Firewalls, Architectures
Education
Fairleigh Dickinson University
Bachelor's degree, Individualized Studies
The College of Westchester
Associate's degree, Computer Systems Management
Amazon Web Services 2014 - Present
Amazon Web Services 2012 - 2014
Stryker 2005 - 2012
GRIDPEAK, LLC 1998 - 2012
Eisai Medical Research 2004 - 2005
WTBTS 1998 - 2004
The College of Westchester 1996 - 1998
Skills
Strategy, Infrastructure..., Cloud Computing, IaaS, Enterprise Architecture, Leadership, Microsoft Operating..., VMware Infrastructure, Citrix, SharePoint, Network Design, VMware, Amazon Web Services..., Servers, Enterprise Software, Scalability, Disaster Recovery, Virtualization, Infrastructure, IT Operations, Microsoft Exchange, Data Center, Technical Support, System Architecture, Windows Server, Software Development, Architecture, System Administration, Windows, High Availability, Integration, System Deployment, Microsoft Technologies, IT Management, Web Services, IT Strategy, Storage Area Networks, Storage, SaaS, Computer Security, IIS, Solution Architecture, DNS, VMware ESX, ITIL, Server Architecture, SAN, IT Service Management, Firewalls, Architectures
Education
Fairleigh Dickinson University
Bachelor's degree, Individualized Studies
The College of Westchester
Associate's degree, Computer Systems Management
Gaetano Lardieri MPM Gaetano Lardieri MPM's Eisai Medical Research Experience 2004 - 2006
Job Global Project ManagerePRO(Consultant) at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences October 2014 - Present
Gates @ Rome Codominium August 2003 - Present
Covance February 2012 - April 2014
Forest Labs November 2011 - February 2012
Eisai Pharmaceuticals July 2006 - May 2011
Eisai Medical Research 2004 - 2006
Pfizer 2002 - 2004
Kendle International 2001 - 2002
Schering-Plough Research Institute January 2001 - August 2001
Merck June 2000 - November 2000
Skills
Clinical Trials, Oncology, CRO, CTMS, Pharmaceutical Industry, Clinical Development, Clinical Research, Clinical Data Management, Data Management, Sop, GCP, Medical Writing, EDC, Healthcare, Process Improvement, Therapeutic Areas, Cross-functional Team..., Infectious Diseases, Biotechnology, 21 CFR Part 11, Regulatory Submissions, MS Project, Hospitals, Microsoft Excel, Pharmacovigilance, Software Documentation, ICH-GCP, Oracle Clinical, PowerPoint, ProSeries, Clinical Study Design, Clinical Monitoring, Documentum, Lotus Notes, Quality Management, Clinical Trial..., Pharmaceuticals, Document Management, Vendor Management, Primavera P6, Validation, Phase I, Change Control, Excel, Primavera, VISIO, ClinTrials, Word-2010, OSHA 10-Hour, OSHA 30-Hour
Education
Rutgers, The State University of New Jersey-Newark 1987 — 1994
BA, PhilosophyPsychologySocial Work
PRA Health Sciences October 2014 - Present
Gates @ Rome Codominium August 2003 - Present
Covance February 2012 - April 2014
Forest Labs November 2011 - February 2012
Eisai Pharmaceuticals July 2006 - May 2011
Eisai Medical Research 2004 - 2006
Pfizer 2002 - 2004
Kendle International 2001 - 2002
Schering-Plough Research Institute January 2001 - August 2001
Merck June 2000 - November 2000
Skills
Clinical Trials, Oncology, CRO, CTMS, Pharmaceutical Industry, Clinical Development, Clinical Research, Clinical Data Management, Data Management, Sop, GCP, Medical Writing, EDC, Healthcare, Process Improvement, Therapeutic Areas, Cross-functional Team..., Infectious Diseases, Biotechnology, 21 CFR Part 11, Regulatory Submissions, MS Project, Hospitals, Microsoft Excel, Pharmacovigilance, Software Documentation, ICH-GCP, Oracle Clinical, PowerPoint, ProSeries, Clinical Study Design, Clinical Monitoring, Documentum, Lotus Notes, Quality Management, Clinical Trial..., Pharmaceuticals, Document Management, Vendor Management, Primavera P6, Validation, Phase I, Change Control, Excel, Primavera, VISIO, ClinTrials, Word-2010, OSHA 10-Hour, OSHA 30-Hour
Education
Rutgers, The State University of New Jersey-Newark 1987 — 1994
BA, PhilosophyPsychologySocial Work
Lilia Taningco Lilia Taningco's Eisai Medical Research Experience 2002 - June 2005
Job Clinical Trial Head Oncology at Novartis
Industry Pharmaceuticals
Experience
Novartis December 2011 - Present
Novartis January 2008 - January 2012
Mitsubishi Pharma America July 2005 - December 2007
Eisai Medical Research 2002 - June 2005
PRA International 2000 - 2002
Covance 1999 - 2000
Huntingdon Life Sciences 1998 - 1999
Skills
Oncology, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Clinical Research, CTMS, CRO, Drug Development, Clinical Operations, Therapeutic Areas
Education
Rutgers, The State University of New Jersey-New Brunswick 1993 — 1998
BS, Biology (Neuroscience)
Novartis December 2011 - Present
Novartis January 2008 - January 2012
Mitsubishi Pharma America July 2005 - December 2007
Eisai Medical Research 2002 - June 2005
PRA International 2000 - 2002
Covance 1999 - 2000
Huntingdon Life Sciences 1998 - 1999
Skills
Oncology, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Clinical Research, CTMS, CRO, Drug Development, Clinical Operations, Therapeutic Areas
Education
Rutgers, The State University of New Jersey-New Brunswick 1993 — 1998
BS, Biology (Neuroscience)
Tim Zeena Tim Zeena's Eisai Medical Research Experience August 2007 - August 2009
Job Contract Statistical Programmer
Industry Biotechnology
Experience
Eisai Medical Research August 2007 - August 2009
Genzyme 2007 - 2007
Indevus Pharmaceuticals 2004 - 2006
CareStat 2002 - 2004
Synarc 2002 - 2003
Sepracor 1999 - 2000
Abt Associates 1997 - 1999
PAREXEL 1992 - 1994
Skills
CDISC, SAS, Biostatistics, CRO, Clinical Development, Oracle Clinical, Clinical Trials, Regulatory Affairs, Interpersonal Savvy, Statistical Programming, Clinical Data Management, 21 CFR Part 11, Data Mining, EDC, Data Management, SDTM, Validation, Oncology, GCP, SAS programming, Clinical Research, Pharmaceutical Industry, Protocol, Macro, Sop, CRF design, FDA, Regulatory Submissions, Drug Development, Therapeutic Areas, Biotechnology, Infectious Diseases
Education
University of Massachusetts, Amherst 1986 — 1988
BS, Psych
Wachusett 1979 — 1983
Bryant University
Eisai Medical Research August 2007 - August 2009
Genzyme 2007 - 2007
Indevus Pharmaceuticals 2004 - 2006
CareStat 2002 - 2004
Synarc 2002 - 2003
Sepracor 1999 - 2000
Abt Associates 1997 - 1999
PAREXEL 1992 - 1994
Skills
CDISC, SAS, Biostatistics, CRO, Clinical Development, Oracle Clinical, Clinical Trials, Regulatory Affairs, Interpersonal Savvy, Statistical Programming, Clinical Data Management, 21 CFR Part 11, Data Mining, EDC, Data Management, SDTM, Validation, Oncology, GCP, SAS programming, Clinical Research, Pharmaceutical Industry, Protocol, Macro, Sop, CRF design, FDA, Regulatory Submissions, Drug Development, Therapeutic Areas, Biotechnology, Infectious Diseases
Education
University of Massachusetts, Amherst 1986 — 1988
BS, Psych
Wachusett 1979 — 1983
Bryant University
Bryan Facca Bryan Facca's Eisai Medical Research Experience July 2012 - Present
Job Medical Science Liaison Eisai Pharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Medical Research July 2012 - Present
GlaxoSmithKline January 2000 - July 2012
Metropolitan Hospital June 1992 - January 2000
Children's Hospital of Michigan 1987 - 1989
Harper Hospital 1978 - 1987
Skills
Oncology, Neurology, Psychiatry, Infectious Diseases, Urology, Gastroenterology, Clinical Trials, Clinical Development, Medicine, Medical Affairs, Medical Education, Hospitals, Pharmacy, Therapeutic Areas, Clinical Research, Pediatrics, Medical Writing
Education
Ferris State University 1990 — 1992
Doctorate of Pharmacy, Pharmacy, Pharmacology
Wayne State University 1975 — 1978
PharmD, Pharmacy, Pharmacology
Eisai Medical Research July 2012 - Present
GlaxoSmithKline January 2000 - July 2012
Metropolitan Hospital June 1992 - January 2000
Children's Hospital of Michigan 1987 - 1989
Harper Hospital 1978 - 1987
Skills
Oncology, Neurology, Psychiatry, Infectious Diseases, Urology, Gastroenterology, Clinical Trials, Clinical Development, Medicine, Medical Affairs, Medical Education, Hospitals, Pharmacy, Therapeutic Areas, Clinical Research, Pediatrics, Medical Writing
Education
Ferris State University 1990 — 1992
Doctorate of Pharmacy, Pharmacy, Pharmacology
Wayne State University 1975 — 1978
PharmD, Pharmacy, Pharmacology
Nadeesha Lihinikadu Arachchige's Eisai Medical Research Experience June 2007 - August 2007
Job Graduate Teaching Assistant ,Kansas State University
Industry
Experience
Kansas State University August 2009 - Present
Kansas State University August 2012 - January 2013
Eisai Medical Research June 2007 - August 2007
Skills
Statistics, SAS, R, Matlab, Minitab, SPSS, Microsoft office..., Research
Education
Kansas State University 2009 — 2013
Master of Science, Statistics
Wichita State University 2007 — 2009
Master of Science (M.S.), Applied Mathematics
Wichita State University 2002 — 2006
Bachelor of Science (B.S.), Mathematics, emphasis in Statistics.
Kansas State University August 2009 - Present
Kansas State University August 2012 - January 2013
Eisai Medical Research June 2007 - August 2007
Skills
Statistics, SAS, R, Matlab, Minitab, SPSS, Microsoft office..., Research
Education
Kansas State University 2009 — 2013
Master of Science, Statistics
Wichita State University 2007 — 2009
Master of Science (M.S.), Applied Mathematics
Wichita State University 2002 — 2006
Bachelor of Science (B.S.), Mathematics, emphasis in Statistics.
Matthew Medlock Matthew Medlock's Eisai Medical Research Experience July 2004 - September 2006
Job Medical Director at Covance
Industry Pharmaceuticals
Experience
Covance October 2013 - Present
PPDI October 2006 - October 2013
Eisai Medical Research July 2004 - September 2006
Skills
Clinical Trials, CRO, Clinical Data Management, Drug Development, CTMS, Clinical Development, Oncology, GCP, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Clinical Research, FDA, Therapeutic Areas, ICH-GCP
Education
Uniformed Services University of the Health Sciences 2002 — 2004
Fellow, Clinical Pharmacology
The University of Texas Southwestern Medical School 1990 — 1994
MD
The University of Texas at Austin 1986 — 1989
BA, Biology
Covance October 2013 - Present
PPDI October 2006 - October 2013
Eisai Medical Research July 2004 - September 2006
Skills
Clinical Trials, CRO, Clinical Data Management, Drug Development, CTMS, Clinical Development, Oncology, GCP, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Clinical Research, FDA, Therapeutic Areas, ICH-GCP
Education
Uniformed Services University of the Health Sciences 2002 — 2004
Fellow, Clinical Pharmacology
The University of Texas Southwestern Medical School 1990 — 1994
MD
The University of Texas at Austin 1986 — 1989
BA, Biology
Steven Elkin Steven Elkin's Eisai Medical Research Experience 2002 - 2007
Job Director, Statistical Programming at The Medicines Company
Industry Pharmaceuticals
Experience
The Medicines Company December 2010 - Present
Hoffmann-La Roche February 2007 - December 2010
Eisai Medical Research 2002 - 2007
SAS Institute 2000 - 2002
J&J - PRI 1998 - 2000
Novartis 1996 - 1999
Pfizer 1993 - 1996
Whitehall Laboratories, Inc. 1991 - 1993
Skills
Clinical Development, Clinical Trials, CRO, Pharmaceutical Industry, Data Management, FDA, Validation, SAS programming, Biotechnology
Education
Stony Brook University 1989 — 1990
MS, Statistics
Alfred University 1982 — 1986
BS, Ceramic Engineering
The Medicines Company December 2010 - Present
Hoffmann-La Roche February 2007 - December 2010
Eisai Medical Research 2002 - 2007
SAS Institute 2000 - 2002
J&J - PRI 1998 - 2000
Novartis 1996 - 1999
Pfizer 1993 - 1996
Whitehall Laboratories, Inc. 1991 - 1993
Skills
Clinical Development, Clinical Trials, CRO, Pharmaceutical Industry, Data Management, FDA, Validation, SAS programming, Biotechnology
Education
Stony Brook University 1989 — 1990
MS, Statistics
Alfred University 1982 — 1986
BS, Ceramic Engineering
Beth Adriano Beth Adriano's Eisai Medical Research Experience September 2009 - December 2011
Job Senior Clinical Data Manager at Johnson & Johnson
Industry Pharmaceuticals
Experience
Johnson & Johnson November 2011 - Present
Eisai Medical Research September 2009 - December 2011
Schering October 2006 - September 2009
Pfizer October 2004 - October 2006
Skills
Registered Nurse
Education
Kean University 2000 — 2002
BSN, Nursing
Middlesex County College 1990 — 1992
ASN, Nursing
Johnson & Johnson November 2011 - Present
Eisai Medical Research September 2009 - December 2011
Schering October 2006 - September 2009
Pfizer October 2004 - October 2006
Skills
Registered Nurse
Education
Kean University 2000 — 2002
BSN, Nursing
Middlesex County College 1990 — 1992
ASN, Nursing
Norma Lewis Norma Lewis's Eisai Medical Research Experience April 2001 - January 2011
Job RA Project Manager at Celgene (consultant)
Industry Pharmaceuticals
Experience
Celgene November 2012 - Present
MedAvante July 2012 - November 2012
Eisai Pharmaceuticals April 2001 - September 2012
Eisai Medical Research April 2001 - January 2011
Esiai 2001 - 2010
Eisai Medical Research 2003 - 2009
Eisai Medical Research 2003 - 2009
Skills
Clinical, Clinical Trials, Research, Clinical Development, Budgeting, Life Sciences, Pharmaceuticals, Planning, R&D, Cross-functional Team..., Regulatory Affairs, CTMS, Therapeutic Areas, Pharmaceutics, Lifesciences, Oncology, CRO, Clinical Research, GCP, Medical Writing, Pharmaceutical Industry, Infectious Diseases, Neurology, Pharmacovigilance, Drug Development, Project Planning, Sop, EDC, Regulatory Submissions, Diabetes, Budgets, 21 CFR Part 11, Clinical Monitoring, Clinical Data Management, Biotechnology, Biopharmaceuticals, FDA, Medical Devices
Education
Thomas Edison State College
Celgene November 2012 - Present
MedAvante July 2012 - November 2012
Eisai Pharmaceuticals April 2001 - September 2012
Eisai Medical Research April 2001 - January 2011
Esiai 2001 - 2010
Eisai Medical Research 2003 - 2009
Eisai Medical Research 2003 - 2009
Skills
Clinical, Clinical Trials, Research, Clinical Development, Budgeting, Life Sciences, Pharmaceuticals, Planning, R&D, Cross-functional Team..., Regulatory Affairs, CTMS, Therapeutic Areas, Pharmaceutics, Lifesciences, Oncology, CRO, Clinical Research, GCP, Medical Writing, Pharmaceutical Industry, Infectious Diseases, Neurology, Pharmacovigilance, Drug Development, Project Planning, Sop, EDC, Regulatory Submissions, Diabetes, Budgets, 21 CFR Part 11, Clinical Monitoring, Clinical Data Management, Biotechnology, Biopharmaceuticals, FDA, Medical Devices
Education
Thomas Edison State College
Juan Morgan Juan Morgan's Eisai Medical Research Experience April 2000 - May 2006
Job Professional Truck Driver
Industry Transportation/Trucking/Railroad
Experience
ATAP Video Productions LLC July 2006 - Present
Maximum Quality Foods March 2012 - September 2013
Warner Chilcott January 2008 - October 2011
Warner Chilcott January 2008 - October 2011
Eisai Medical Research April 2000 - May 2006
Eisai Inc. April 2000 - March 2006
Kendle International November 1999 - May 2000
Skills
Videographer, Film Editing, Corporate Events, Clinical Trials, Data Management, Clinical Monitoring, Clinical Research, Training, Databases, Data Analysis, Data Entry, Pharmaceutics, Testing, 21 CFR Part 11, Customer Service, Software Documentation, Sop
Education
University of Phoenix 2003 — 2007
BA, Business
Hillside High School 1983 — 1997
Diploma, General Studies
ATAP Video Productions LLC July 2006 - Present
Maximum Quality Foods March 2012 - September 2013
Warner Chilcott January 2008 - October 2011
Warner Chilcott January 2008 - October 2011
Eisai Medical Research April 2000 - May 2006
Eisai Inc. April 2000 - March 2006
Kendle International November 1999 - May 2000
Skills
Videographer, Film Editing, Corporate Events, Clinical Trials, Data Management, Clinical Monitoring, Clinical Research, Training, Databases, Data Analysis, Data Entry, Pharmaceutics, Testing, 21 CFR Part 11, Customer Service, Software Documentation, Sop
Education
University of Phoenix 2003 — 2007
BA, Business
Hillside High School 1983 — 1997
Diploma, General Studies
Cami Jamison's Eisai Medical Research Experience 2003 - 2007
Job Sr. Clinical Trial Manager
Industry Pharmaceuticals
Experience
Forest Research, a subsidary of Actavis March 2010 - Present
Roche Pharmaceuticals March 2007 - March 2010
Eisai Medical Research 2003 - 2007
Kendle International 2001 - 2003
University of Nebraska Medical Center 1992 - 2001
Skills
Oncology, Clinical Monitoring, Hypertension, Vaccines, Immunology, Clinical Research, Clinical Development, CTMS, Diabetes, EDC, Clinical Operations, CRO
Education
University of Nebraska at Omaha 1987 — 1992
BA, Biology, Psychology
Forest Research, a subsidary of Actavis March 2010 - Present
Roche Pharmaceuticals March 2007 - March 2010
Eisai Medical Research 2003 - 2007
Kendle International 2001 - 2003
University of Nebraska Medical Center 1992 - 2001
Skills
Oncology, Clinical Monitoring, Hypertension, Vaccines, Immunology, Clinical Research, Clinical Development, CTMS, Diabetes, EDC, Clinical Operations, CRO
Education
University of Nebraska at Omaha 1987 — 1992
BA, Biology, Psychology
Archana Reddy's Eisai Medical Research Experience February 2006 - May 2007
Job Regulatory Advisor
Industry Pharmaceuticals
Experience
inBiotechnologies August 2015 - Present
LLOYD September 2014 - August 2015
George Washington University August 2013 - December 2014
CONRAD January 2014 - September 2014
Ipsen June 2012 - April 2013
Mitsubishi Tanabe Pharma Development America August 2010 - May 2012
medicines360 October 2009 - February 2010
Catalent Pharma Solutions June 2008 - October 2009
Bayer HealthCare June 2007 - May 2008
Eisai Medical Research February 2006 - May 2007
Skills
Regulatory Affairs, Regulatory Submissions, FDA, Clinical Development, Pharmaceutical Industry, Clinical Research, Drug Development, NDA, Strategy, Biotechnology, IND, Biopharmaceuticals, Regulatory Requirements, Therapeutic Areas, Clinical Trials, CMC, CRO, SOP, Cross-functional Team..., eCTD, Pharmaceutics, Clinical Study Design, Neurology, GCP, Medical Writing, Biologics, Consulting, Pharmacovigilance, GMP, Technology Transfer, Combination Products, Women's Health, Endocrinology, Oncology, Orphan Drugs, Life Sciences, Regulations, Management, Leadership
Education
Concord Law School - Kaplan University 2015 — 2019
Doctor of Law (JD)
Columbia University in the City of New York 1997 — 1999
MPH, Health Policy
The Johns Hopkins University 1996 — 1997
M.S., Biotechnology
Vanderbilt University 1991 — 1995
BA, Chemistry/Spanish
inBiotechnologies August 2015 - Present
LLOYD September 2014 - August 2015
George Washington University August 2013 - December 2014
CONRAD January 2014 - September 2014
Ipsen June 2012 - April 2013
Mitsubishi Tanabe Pharma Development America August 2010 - May 2012
medicines360 October 2009 - February 2010
Catalent Pharma Solutions June 2008 - October 2009
Bayer HealthCare June 2007 - May 2008
Eisai Medical Research February 2006 - May 2007
Skills
Regulatory Affairs, Regulatory Submissions, FDA, Clinical Development, Pharmaceutical Industry, Clinical Research, Drug Development, NDA, Strategy, Biotechnology, IND, Biopharmaceuticals, Regulatory Requirements, Therapeutic Areas, Clinical Trials, CMC, CRO, SOP, Cross-functional Team..., eCTD, Pharmaceutics, Clinical Study Design, Neurology, GCP, Medical Writing, Biologics, Consulting, Pharmacovigilance, GMP, Technology Transfer, Combination Products, Women's Health, Endocrinology, Oncology, Orphan Drugs, Life Sciences, Regulations, Management, Leadership
Education
Concord Law School - Kaplan University 2015 — 2019
Doctor of Law (JD)
Columbia University in the City of New York 1997 — 1999
MPH, Health Policy
The Johns Hopkins University 1996 — 1997
M.S., Biotechnology
Vanderbilt University 1991 — 1995
BA, Chemistry/Spanish
Sherezada Torres Sherezada Torres's Eisai Medical Research Experience November 2008 - March 2009
Job Delivering quality service, that helps connect clients with Talent
Industry Pharmaceuticals
Experience
Konica Minolta Business Solutions U.S.A., Inc. September 2015 - Present
Novo Nordisk A/S September 2013 - December 2014
TIAA-CREF August 2011 - December 2012
Eisai Medical Research November 2008 - March 2009
Physicians World April 2003 - June 2007
Skills
Outlook, PowerPoint, Word, Excel, Process Scheduler, Customer Service, Microsoft Office, Budgets, Event Planning, Leadership, Strategic Planning, Healthcare, Account Management, Social Media, Process Improvement, Human Resources, Team Building, Meeting Planning, Call Center, Office Management, Microsoft Excel, Event Management, Marketing Communications, Public Speaking, Leadership Development, Recruiting, Time Management, Administration, Employee Relations, Project Management, Access, Interviews, Microsoft Word, Teamwork, Team Leadership, HRIS, Administrative..., Management, Training, Sales, Organizational..., Talent Acquisition, Call Centers, Coaching, Onboarding
Education
Kaplan University 2010 — 2016
Bachelors of Science, Psychology of Behavioral Analysis, 3.29
Bergen Community College 2005 — 2006
Social Science
Konica Minolta Business Solutions U.S.A., Inc. September 2015 - Present
Novo Nordisk A/S September 2013 - December 2014
TIAA-CREF August 2011 - December 2012
Eisai Medical Research November 2008 - March 2009
Physicians World April 2003 - June 2007
Skills
Outlook, PowerPoint, Word, Excel, Process Scheduler, Customer Service, Microsoft Office, Budgets, Event Planning, Leadership, Strategic Planning, Healthcare, Account Management, Social Media, Process Improvement, Human Resources, Team Building, Meeting Planning, Call Center, Office Management, Microsoft Excel, Event Management, Marketing Communications, Public Speaking, Leadership Development, Recruiting, Time Management, Administration, Employee Relations, Project Management, Access, Interviews, Microsoft Word, Teamwork, Team Leadership, HRIS, Administrative..., Management, Training, Sales, Organizational..., Talent Acquisition, Call Centers, Coaching, Onboarding
Education
Kaplan University 2010 — 2016
Bachelors of Science, Psychology of Behavioral Analysis, 3.29
Bergen Community College 2005 — 2006
Social Science
Bill McLaughlin's Eisai Medical Research Experience 2000 - 2004
Job
Industry Pharmaceuticals
Experience
Cost Management Incentives April 2012 - Present
Mitsubishi Tanabe Pharma Development America, Inc. 2006 - 2012
Neurobiological Technologies, Inc. 2004 - 2006
Eisai Medical Research 2000 - 2004
Knoll Pharmaceutical Company 1998 - 2000
Oxford Research International Corporation 1997 - 1998
Somatix Therapy Corporation 1992 - 1997
Hahnemann University Hospital 1990 - 1992
Monell Chemical Senses Center 1989 - 1990
Skills
CTMS, EDC, Drug Development, Clinical Development, Clinical Trials, GCP, Pharmaceutical Industry, CRO, Clinical Research, Clinical Operations, Clinical Monitoring, Diabetes, Cardiology, Biopharmaceuticals, 21 CFR Part 11, Clinical Study Design, FDA, ICH-GCP, IND, Infectious Diseases, Lifesciences, Medical Devices, Neurology, Neuroscience, Protocol, R, Therapeutic Areas, Life Sciences
Education
Villanova University 1987 — 1989
MS, General / Experimental Psychology
Rowan University 1983 — 1987
BA, cum laude, Psychology; concentration - Philosophy/Religion
Sacred Heart High School 1979 — 1983
College Preparation
Sacred Heart Regional Grammar School 1971 — 1979
Cost Management Incentives April 2012 - Present
Mitsubishi Tanabe Pharma Development America, Inc. 2006 - 2012
Neurobiological Technologies, Inc. 2004 - 2006
Eisai Medical Research 2000 - 2004
Knoll Pharmaceutical Company 1998 - 2000
Oxford Research International Corporation 1997 - 1998
Somatix Therapy Corporation 1992 - 1997
Hahnemann University Hospital 1990 - 1992
Monell Chemical Senses Center 1989 - 1990
Skills
CTMS, EDC, Drug Development, Clinical Development, Clinical Trials, GCP, Pharmaceutical Industry, CRO, Clinical Research, Clinical Operations, Clinical Monitoring, Diabetes, Cardiology, Biopharmaceuticals, 21 CFR Part 11, Clinical Study Design, FDA, ICH-GCP, IND, Infectious Diseases, Lifesciences, Medical Devices, Neurology, Neuroscience, Protocol, R, Therapeutic Areas, Life Sciences
Education
Villanova University 1987 — 1989
MS, General / Experimental Psychology
Rowan University 1983 — 1987
BA, cum laude, Psychology; concentration - Philosophy/Religion
Sacred Heart High School 1979 — 1983
College Preparation
Sacred Heart Regional Grammar School 1971 — 1979
Silvana Giustino Silvana Giustino's Eisai Medical Research Experience March 2008 - May 2009
Job Vice President, Clinical Affairs at Amneal Pharmaceuticals
Industry Pharmaceuticals
Experience
Amneal Pharmaceuticals January 2015 - Present
Eisai March 2008 - December 2013
Eisai Inc June 2009 - April 2012
Eisai Medical Research March 2008 - May 2009
Pfizer Inc March 1998 - March 2008
Advanced Biomedical Research September 1994 - February 1998
Health and Sciences Research, Inc. 1989 - 1994
Skills
Clinical Trials, Therapeutic Areas, Clinical Research, Medical Writing, Clinical Operations, Data Management, Phase I, CTMS, Clinical Data Management, Drug Development, Clinical Development, CRO, Clinical Monitoring, Clinical Study Design, EDC, GCP, IND, Pharmaceutical Industry, Pharmacovigilance, Infectious Diseases, Regulatory Submissions, Regulatory Affairs
Education
City University of New York-Herbert H. Lehman College 1976 — 1981
BSN, Nursing
Amneal Pharmaceuticals January 2015 - Present
Eisai March 2008 - December 2013
Eisai Inc June 2009 - April 2012
Eisai Medical Research March 2008 - May 2009
Pfizer Inc March 1998 - March 2008
Advanced Biomedical Research September 1994 - February 1998
Health and Sciences Research, Inc. 1989 - 1994
Skills
Clinical Trials, Therapeutic Areas, Clinical Research, Medical Writing, Clinical Operations, Data Management, Phase I, CTMS, Clinical Data Management, Drug Development, Clinical Development, CRO, Clinical Monitoring, Clinical Study Design, EDC, GCP, IND, Pharmaceutical Industry, Pharmacovigilance, Infectious Diseases, Regulatory Submissions, Regulatory Affairs
Education
City University of New York-Herbert H. Lehman College 1976 — 1981
BSN, Nursing
Yuguang Zhao Yuguang Zhao's Eisai Medical Research Experience March 2007 - December 2009
Job K&L Consulting Services, Inc.
Industry Pharmaceuticals
Experience
K&L Consulting Services November 2010 - Present
Eisai January 2010 - November 2010
Eisai Medical Research March 2007 - December 2009
sanofi-aventis August 1997 - March 2007
Education
Oregon State University
K&L Consulting Services November 2010 - Present
Eisai January 2010 - November 2010
Eisai Medical Research March 2007 - December 2009
sanofi-aventis August 1997 - March 2007
Education
Oregon State University
Kristian Hubbard Kristian Hubbard's Eisai Medical Research Experience July 2006 - October 2009
Job Outsourcing Manager, Clinical Science and Operations Department at BristolMyers Squibb
Industry Outsourcing/Offshoring
Experience
Bristol-Myers Squibb October 2009 - Present
Eisai Medical Research July 2006 - October 2009
Atlantic Health 2004 - 2006
Policy Studies Inc. February 2002 - June 2004
Skills
Vendor Management, Business Intelligence, Strategic Negotiations, Due Diligence, Strategic Planning, Cost Analysis -..., CRO Industry, Strategic Relationships, SharePoint, Performance Metrics, Clinical Trials, Pharmaceutical Industry, Biotechnology, CRO, Clinical Data Management, CTMS, Clinical Research, Contract Negotiation, Cross-functional Team..., GCP, Oncology, Outsourcing, Process Improvement, EDC, Protocol, Strategy, Regulatory Affairs, Clinical Development, Pharmacovigilance, Therapeutic Areas, Regulatory Submissions, 21 CFR Part 11, Sop, Life Sciences, Healthcare, Management, SOP
Education
William Paterson University of New Jersey 1997 — 2000
BA, Political Science
Seton Hall University
MHA, Healthcare Administration
Bristol-Myers Squibb October 2009 - Present
Eisai Medical Research July 2006 - October 2009
Atlantic Health 2004 - 2006
Policy Studies Inc. February 2002 - June 2004
Skills
Vendor Management, Business Intelligence, Strategic Negotiations, Due Diligence, Strategic Planning, Cost Analysis -..., CRO Industry, Strategic Relationships, SharePoint, Performance Metrics, Clinical Trials, Pharmaceutical Industry, Biotechnology, CRO, Clinical Data Management, CTMS, Clinical Research, Contract Negotiation, Cross-functional Team..., GCP, Oncology, Outsourcing, Process Improvement, EDC, Protocol, Strategy, Regulatory Affairs, Clinical Development, Pharmacovigilance, Therapeutic Areas, Regulatory Submissions, 21 CFR Part 11, Sop, Life Sciences, Healthcare, Management, SOP
Education
William Paterson University of New Jersey 1997 — 2000
BA, Political Science
Seton Hall University
MHA, Healthcare Administration
Barbara Miranda Barbara Miranda's Eisai Medical Research Experience January 2003 - November 2012
Job Asset Planning Manager at Pfizer
Industry Pharmaceuticals
Experience
Pfizer April 2014 - Present
Forest Laboratories January 2013 - June 2013
Eisai Medical Research January 2003 - November 2012
Eisai Medical Research January 2003 - December 2006
Skills
Pharmaceutical Industry, Clinical Trials, Change Control, Project Management, Document Management, GCP, CRO, Clinical Development, Process Improvement, Team Leadership, GxP, EDC, Project Planning, Pharmacovigilance, Biotechnology, Regulatory Affairs, Regulatory Requirements, Medical Writing, Quality Assurance, Software Documentation, MS Project, Oncology, Sop, Clinical Research, FDA, Protocol, GMP, GLP, Drug Development, IND, Strategic Planning, CTMS, Budgets, Validation, Computer System..., Clinical Data Management, Data Management, 21 CFR Part 11, Cross-functional Team..., Regulatory Submissions, Management, Therapeutic Areas, Biopharmaceuticals, Infectious Diseases, Clinical Operations, Vaccines
Education
Felician College
MBA, Management with a Concentration on Organizational Management
Pfizer April 2014 - Present
Forest Laboratories January 2013 - June 2013
Eisai Medical Research January 2003 - November 2012
Eisai Medical Research January 2003 - December 2006
Skills
Pharmaceutical Industry, Clinical Trials, Change Control, Project Management, Document Management, GCP, CRO, Clinical Development, Process Improvement, Team Leadership, GxP, EDC, Project Planning, Pharmacovigilance, Biotechnology, Regulatory Affairs, Regulatory Requirements, Medical Writing, Quality Assurance, Software Documentation, MS Project, Oncology, Sop, Clinical Research, FDA, Protocol, GMP, GLP, Drug Development, IND, Strategic Planning, CTMS, Budgets, Validation, Computer System..., Clinical Data Management, Data Management, 21 CFR Part 11, Cross-functional Team..., Regulatory Submissions, Management, Therapeutic Areas, Biopharmaceuticals, Infectious Diseases, Clinical Operations, Vaccines
Education
Felician College
MBA, Management with a Concentration on Organizational Management
Scott Kelly, PMP, CSM Scott Kelly, PMP, CSM's Eisai Medical Research Experience 2007 - October 2010
Job Global Program Manager at EMC
Industry Information Technology and Services
Experience
EMC April 2014 - Present
EMC April 2012 - Present
TekSystems Inc. May 2011 - April 2012
CCR IT Consulting November 2010 - April 2011
Eisai Global Clinical January 2007 - October 2010
Eisai Medical Research 2007 - October 2010
McGraw Hill Companies January 2006 - December 2006
Schering Plough January 1998 - December 2005
Skills
Agile Project Management, IT Outsourcing, Financial Management, IT Strategy, Business Alignment, Pharmaceuticals, System Architecture, Coaching, Certified Scrum Master..., Vendor Management, MS Office Suite, PMP, ITIL, Data Center, PMO, Process Improvement, Integration, Customer Relations, Program Management, SDLC, Project Portfolio..., Team Building, IT Management, Cross-functional Team..., IT Governance, Agile, SLA, Strategic Planning, Pharmaceutical Industry, Disaster Recovery, Strategy, Cloud Computing, Business Process, Management, Project Management, Software Development, Project Planning, Agile Methodologies, Business Analysis, Enterprise Software, Consulting, Leadership, Infrastructure, Requirements Gathering
Education
Stevens Institute of Technology 2000 — 2005
Masters Degree, Information Systems
Lafayette College 1981 — 1985
BS, Industrial Engineering
EMC April 2014 - Present
EMC April 2012 - Present
TekSystems Inc. May 2011 - April 2012
CCR IT Consulting November 2010 - April 2011
Eisai Global Clinical January 2007 - October 2010
Eisai Medical Research 2007 - October 2010
McGraw Hill Companies January 2006 - December 2006
Schering Plough January 1998 - December 2005
Skills
Agile Project Management, IT Outsourcing, Financial Management, IT Strategy, Business Alignment, Pharmaceuticals, System Architecture, Coaching, Certified Scrum Master..., Vendor Management, MS Office Suite, PMP, ITIL, Data Center, PMO, Process Improvement, Integration, Customer Relations, Program Management, SDLC, Project Portfolio..., Team Building, IT Management, Cross-functional Team..., IT Governance, Agile, SLA, Strategic Planning, Pharmaceutical Industry, Disaster Recovery, Strategy, Cloud Computing, Business Process, Management, Project Management, Software Development, Project Planning, Agile Methodologies, Business Analysis, Enterprise Software, Consulting, Leadership, Infrastructure, Requirements Gathering
Education
Stevens Institute of Technology 2000 — 2005
Masters Degree, Information Systems
Lafayette College 1981 — 1985
BS, Industrial Engineering
Michele Jankowski Michele Jankowski's Eisai Medical Research Experience April 2009 - May 2011
Job Senior Clinical Data Manager
Industry Pharmaceuticals
Experience
Eisai Medical Research April 2009 - May 2011
Pfizer January 2001 - April 2007
Pfizer 1992 - 2000
Skills
Clinical Data Management, Clinical Trials, CRF design, GCP, Clinical Development, EDC, Clinical Research, CTMS, ICH-GCP, Pharmaceutical Industry, Oracle Clinical
Education
Rutgers, The State University of New Jersey-New Brunswick 1988 — 1992
B.A., Biological Sciences
Eisai Medical Research April 2009 - May 2011
Pfizer January 2001 - April 2007
Pfizer 1992 - 2000
Skills
Clinical Data Management, Clinical Trials, CRF design, GCP, Clinical Development, EDC, Clinical Research, CTMS, ICH-GCP, Pharmaceutical Industry, Oracle Clinical
Education
Rutgers, The State University of New Jersey-New Brunswick 1988 — 1992
B.A., Biological Sciences
Timothy J. Kuhn Timothy J. Kuhn's Eisai Medical Research Experience March 2003 - August 2005
Job Senior Manager, Global R&D Quality CSV Audit Program Lead at Allergan
Industry Pharmaceuticals
Experience
Allergan August 2012 - Present
Celgene February 2008 - August 2012
sanofi-aventis August 2005 - February 2008
Eisai Medical Research March 2003 - August 2005
Merck & Co. March 1998 - March 2003
Skills
Validation, 21 CFR Part 11, FDA, Quality Assurance, GMP, Pharmaceutical Industry, GxP, GCP, Computer System..., Clinical Development, Clinical Data Management, Quality Auditing, Quality System, Clinical Trials, GLP, Pharmacovigilance, CAPA, Quality Management, Process Improvement, Auditing, Biotechnology, CSV, System Administration, Technology Transfer, Change Control, Software Quality..., Sop, Regulatory Affairs, CRO, Data Quality, Laboratory, Software Documentation, Regulatory Requirements, Quality, Latin America, European Union, Drug Development, Cross-functional Team..., LIMS, GAMP, Pharmaceutics, SDLC, Process Auditing, Quality Systems, V&V, Regulatory Submissions, Biopharmaceuticals, IND, SOP
Education
American Society for Quality 2005 — 2005
CQA, Quality Assurance Auditing
State University of New York College at Geneseo 1991 — 1995
BS, Chemistry
Allergan August 2012 - Present
Celgene February 2008 - August 2012
sanofi-aventis August 2005 - February 2008
Eisai Medical Research March 2003 - August 2005
Merck & Co. March 1998 - March 2003
Skills
Validation, 21 CFR Part 11, FDA, Quality Assurance, GMP, Pharmaceutical Industry, GxP, GCP, Computer System..., Clinical Development, Clinical Data Management, Quality Auditing, Quality System, Clinical Trials, GLP, Pharmacovigilance, CAPA, Quality Management, Process Improvement, Auditing, Biotechnology, CSV, System Administration, Technology Transfer, Change Control, Software Quality..., Sop, Regulatory Affairs, CRO, Data Quality, Laboratory, Software Documentation, Regulatory Requirements, Quality, Latin America, European Union, Drug Development, Cross-functional Team..., LIMS, GAMP, Pharmaceutics, SDLC, Process Auditing, Quality Systems, V&V, Regulatory Submissions, Biopharmaceuticals, IND, SOP
Education
American Society for Quality 2005 — 2005
CQA, Quality Assurance Auditing
State University of New York College at Geneseo 1991 — 1995
BS, Chemistry
Karen Koubek's Eisai Medical Research Experience July 2008 - February 2009
Job Director of Human Resources
Industry Pharmaceuticals
Experience
PTC Therapeutics July 2014 - Present
National Starch Food Innovation March 2009 - June 2009
Eisai Medical Research July 2008 - February 2009
Wyeth November 2005 - February 2008
National Starch & Chemical Co. 2005 - 2005
Tiffany 2004 - 2004
Merck & Co. 1999 - 2004
Skills
Medical Writing, Accounting, Public Relations, Clinical Data Management, Hiring, Human Resources, Interviews, Contract Recruitment, Recruiting, Onboarding, Talent Management, Quality Assurance, SDLC, Talent Acquisition, Leadership, Temporary Placement, Applicant Tracking..., Succession Planning, Management, Biotechnology, Pharmaceutical Industry
Education
Rutgers University-New Brunswick
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (BA), Psychology
PTC Therapeutics July 2014 - Present
National Starch Food Innovation March 2009 - June 2009
Eisai Medical Research July 2008 - February 2009
Wyeth November 2005 - February 2008
National Starch & Chemical Co. 2005 - 2005
Tiffany 2004 - 2004
Merck & Co. 1999 - 2004
Skills
Medical Writing, Accounting, Public Relations, Clinical Data Management, Hiring, Human Resources, Interviews, Contract Recruitment, Recruiting, Onboarding, Talent Management, Quality Assurance, SDLC, Talent Acquisition, Leadership, Temporary Placement, Applicant Tracking..., Succession Planning, Management, Biotechnology, Pharmaceutical Industry
Education
Rutgers University-New Brunswick
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (BA), Psychology
Paul Bychowsky Jr's Eisai Medical Research Experience February 2008 - August 2013
Job Senior Project Manager, Clinical Supply Management at Purdue Pharma L.P.
Industry Pharmaceuticals
Experience
Purdue Pharma L.P. September 2013 - Present
Eisai Medical Research February 2008 - August 2013
AccuLogix January 2007 - February 2008
Kos Pharmaceuticals (subsidiary of Abbott Labs) 2006 - 2007
Pfizer 1998 - 2005
Skills
Clinical Operations, Clinical Supplies, Pharmaceutical Industry, Clinical Trials, Clinical Development, Sop, GMP, CTMS, CRO, GCP, FDA, Oncology, Cross-functional Team..., Regulatory Submissions, Protocol, Quality System, R&D, Process Improvement, 21 CFR Part 11, Clinical Data Management, Clinical Research, Technology Transfer, EDC, Pharmaceutics, SOP
Education
Castleton State College 1993 — 1997
Bachelor of Arts (B.A.), Sociology
St. Bernard High School 1989 — 1993
Purdue Pharma L.P. September 2013 - Present
Eisai Medical Research February 2008 - August 2013
AccuLogix January 2007 - February 2008
Kos Pharmaceuticals (subsidiary of Abbott Labs) 2006 - 2007
Pfizer 1998 - 2005
Skills
Clinical Operations, Clinical Supplies, Pharmaceutical Industry, Clinical Trials, Clinical Development, Sop, GMP, CTMS, CRO, GCP, FDA, Oncology, Cross-functional Team..., Regulatory Submissions, Protocol, Quality System, R&D, Process Improvement, 21 CFR Part 11, Clinical Data Management, Clinical Research, Technology Transfer, EDC, Pharmaceutics, SOP
Education
Castleton State College 1993 — 1997
Bachelor of Arts (B.A.), Sociology
St. Bernard High School 1989 — 1993
Terence Hogan's Eisai Medical Research Experience May 2007 - January 2009
Job General Counsel at Vitis Biologic
Industry Law Practice
Experience
Vitis Biologic August 2015 - Present
Amgen August 2014 - August 2015
Amgen January 2009 - August 2015
Eisai Medical Research May 2007 - January 2009
Catalina and Associates July 2006 - June 2007
pliva 2001 - 2006
Skills
Medical Devices, Healthcare Compliance, GMP, Biotechnology, Privacy, HIPAA, Clinical Development, ANDA, Pharmaceuticals, Regulatory Affairs, Life Sciences, GLP, FDA, IND, CAPA, Clinical Trials, Pharmaceutical Industry, Oncology, Intellectual Property
Education
The Johns Hopkins University 2010 — 2014
MS, Biotechnology
Seton Hall University School of Law 1998 — 2002
Juris Doctorate, Health Law
Montclair State University 1993 — 1995
BS, Biology, minor in Chemistry
Vitis Biologic August 2015 - Present
Amgen August 2014 - August 2015
Amgen January 2009 - August 2015
Eisai Medical Research May 2007 - January 2009
Catalina and Associates July 2006 - June 2007
pliva 2001 - 2006
Skills
Medical Devices, Healthcare Compliance, GMP, Biotechnology, Privacy, HIPAA, Clinical Development, ANDA, Pharmaceuticals, Regulatory Affairs, Life Sciences, GLP, FDA, IND, CAPA, Clinical Trials, Pharmaceutical Industry, Oncology, Intellectual Property
Education
The Johns Hopkins University 2010 — 2014
MS, Biotechnology
Seton Hall University School of Law 1998 — 2002
Juris Doctorate, Health Law
Montclair State University 1993 — 1995
BS, Biology, minor in Chemistry
Ronald Harning's Eisai Medical Research Experience February 2003 - January 2004
Job Director of Clinical Operations, US at Sun Pharmaceutical Industries Ltd
Industry Pharmaceuticals
Experience
Sun Pharmaceutical Industries Ltd October 2011 - Present
Soligenix Inc 2010 - 2011
Teijin America, Inc. 2008 - 2010
Palatin Technologies 2004 - 2007
Eisai Medical Research February 2003 - January 2004
NexMed Inc 2000 - 2003
Merck 1995 - 2000
Roberts Pharmaceutical Corporation 1991 - 1995
Boehringer Ingelheim 1989 - 1991
NY University Medical Center; Kaplan Cancer Center 1988 - 1989
Skills
ASCO Member since 1991, Oncology Clinical..., Clinical Trials, Clinical Research, Infectious Diseases, Clinical Operations, Pharmaceutical Industry, Clinical Development, CRO, CTMS, GCP, Drug Development, FDA, Sop, Biotechnology, Lifesciences, R&D, Medical Devices, Medical Writing, Clinical Data Management, 21 CFR Part 11, Diabetes, Oncology
Education
City University of New York 1984 — 1989
Doctor of Philosophy (PhD), Molecular Oncology
Adelphi University 1978 — 1980
Master's degree, Biology, General
New York University
MS Education
Sun Pharmaceutical Industries Ltd October 2011 - Present
Soligenix Inc 2010 - 2011
Teijin America, Inc. 2008 - 2010
Palatin Technologies 2004 - 2007
Eisai Medical Research February 2003 - January 2004
NexMed Inc 2000 - 2003
Merck 1995 - 2000
Roberts Pharmaceutical Corporation 1991 - 1995
Boehringer Ingelheim 1989 - 1991
NY University Medical Center; Kaplan Cancer Center 1988 - 1989
Skills
ASCO Member since 1991, Oncology Clinical..., Clinical Trials, Clinical Research, Infectious Diseases, Clinical Operations, Pharmaceutical Industry, Clinical Development, CRO, CTMS, GCP, Drug Development, FDA, Sop, Biotechnology, Lifesciences, R&D, Medical Devices, Medical Writing, Clinical Data Management, 21 CFR Part 11, Diabetes, Oncology
Education
City University of New York 1984 — 1989
Doctor of Philosophy (PhD), Molecular Oncology
Adelphi University 1978 — 1980
Master's degree, Biology, General
New York University
MS Education
Terry Wylie's Eisai Medical Research Experience July 2008 - March 2010
Job Program Manager at NTT DATA Inc.
Industry Information Technology and Services
Experience
NTT DATA Corporation March 2010 - Present
Eisai Medical Research July 2008 - March 2010
Keane, Inc. December 2006 - July 2008
First Consulting Group June 2000 - December 2006
Lockheed Martin August 1989 - June 2000
Skills
IT Project Management, IT Program Management, IT Service Delivery..., SDLC, Business Analysis, IT Strategy, Vendor Management, Software Project..., PMO, Management
Education
Burlington County College
Mathematics and Computer Science
NTT DATA Corporation March 2010 - Present
Eisai Medical Research July 2008 - March 2010
Keane, Inc. December 2006 - July 2008
First Consulting Group June 2000 - December 2006
Lockheed Martin August 1989 - June 2000
Skills
IT Project Management, IT Program Management, IT Service Delivery..., SDLC, Business Analysis, IT Strategy, Vendor Management, Software Project..., PMO, Management
Education
Burlington County College
Mathematics and Computer Science
Kim Onal, PHR's Eisai Medical Research Experience 2005 - 2007
Job Associate Director at Eisai
Industry Pharmaceuticals
Experience
Eisai September 2005 - Present
Eisai Medical Research 2005 - 2007
Stryker 2004 - 2005
Goldman Sachs 1996 - 2003
Skills
Recruiting, Performance Management, Sourcing, Employee Relations, Talent Acquisition, Deferred Compensation, Personnel Management, HR Policies, Talent Management, Employee Engagement, Human Resources, Onboarding, HRIS, Workforce Planning, Management, Applicant Tracking..., HR Consulting
Education
Ithaca College 1991 — 1995
Bachelor of Science (BS), Human Resources Management/Personnel Administration, General
Eisai September 2005 - Present
Eisai Medical Research 2005 - 2007
Stryker 2004 - 2005
Goldman Sachs 1996 - 2003
Skills
Recruiting, Performance Management, Sourcing, Employee Relations, Talent Acquisition, Deferred Compensation, Personnel Management, HR Policies, Talent Management, Employee Engagement, Human Resources, Onboarding, HRIS, Workforce Planning, Management, Applicant Tracking..., HR Consulting
Education
Ithaca College 1991 — 1995
Bachelor of Science (BS), Human Resources Management/Personnel Administration, General
Ruchita Nadkarni's Eisai Medical Research Experience 2003 - 2006
Job Medical Writer at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb May 2013 - Present
Makro Technologies September 2006 - February 2008
Eisai Medical Research 2003 - 2006
GSK Biologicals 1999 - 2002
GlaxoSmithKline Pharmaceuticals (India) Pvt. Ltd. 1999 - 2002
Skills
Clinical Development
Education
Manipal University 1995 — 1998
masters, microbiology
Mount Carmel College 1992 — 1995
BSc, Microbiology, Zoology, Chemistry
Sophia High School
Bristol-Myers Squibb May 2013 - Present
Makro Technologies September 2006 - February 2008
Eisai Medical Research 2003 - 2006
GSK Biologicals 1999 - 2002
GlaxoSmithKline Pharmaceuticals (India) Pvt. Ltd. 1999 - 2002
Skills
Clinical Development
Education
Manipal University 1995 — 1998
masters, microbiology
Mount Carmel College 1992 — 1995
BSc, Microbiology, Zoology, Chemistry
Sophia High School
Georgean Arsons's Eisai Medical Research Experience 2003 - 2004
Job Manager
Industry Information Technology and Services
Experience
Pfizer 2007 - 2009
Celgene 2007 - 2007
Clarkston Consulting 2006 - 2006
Bristol-Myers Squibb 2005 - 2005
Eisai Medical Research 2003 - 2004
Bristol-Myers Squibb August 2001 - June 2003
Telcordia Technologies 1998 - 2001
AT&T 1988 - 1998
Skills
21 CFR Part 11, Computer System..., Validation, Project Management, Quality Assurance, Software Documentation, Team Building, FDA, Management, Vendor Management
Education
Fairleigh Dickinson University 2010 — 2010
Legal Studies Certificate with Honors, Legal Studies
George Washington University
Master's, Project Management
Ohio State University
B. S.
University of Illinois at Urbana-Champaign
M. Ed.
Pfizer 2007 - 2009
Celgene 2007 - 2007
Clarkston Consulting 2006 - 2006
Bristol-Myers Squibb 2005 - 2005
Eisai Medical Research 2003 - 2004
Bristol-Myers Squibb August 2001 - June 2003
Telcordia Technologies 1998 - 2001
AT&T 1988 - 1998
Skills
21 CFR Part 11, Computer System..., Validation, Project Management, Quality Assurance, Software Documentation, Team Building, FDA, Management, Vendor Management
Education
Fairleigh Dickinson University 2010 — 2010
Legal Studies Certificate with Honors, Legal Studies
George Washington University
Master's, Project Management
Ohio State University
B. S.
University of Illinois at Urbana-Champaign
M. Ed.
John Strigkas's Eisai Medical Research Experience October 2002 - May 2003
Job Senior Clinical Trial Head at Novartis
Industry Pharmaceuticals
Experience
Novartis July 2010 - Present
Dainippon Sumitomo Pharma/Sepracor Inc June 2008 - July 2010
Novartis May 2003 - June 2008
Eisai Medical Research October 2002 - May 2003
Organon Inc April 2000 - October 2002
Skills
Clinical Trials, 21 CFR Part 11, Biotechnology, CRO, CTMS, Clinical Data Management, Clinical Development, Clinical Research, Computer System..., Drug Development, EDC, FDA, GCP, GLP, GMP, Infectious Diseases, Medical Writing, Neurology, Oncology, Pharmaceutical Industry, Pharmaceutics, Pharmacovigilance, Quality Assurance, Regulatory Affairs, Regulatory Submissions, Sop, Technology Transfer
Education
Fairleigh Dickinson University
Novartis July 2010 - Present
Dainippon Sumitomo Pharma/Sepracor Inc June 2008 - July 2010
Novartis May 2003 - June 2008
Eisai Medical Research October 2002 - May 2003
Organon Inc April 2000 - October 2002
Skills
Clinical Trials, 21 CFR Part 11, Biotechnology, CRO, CTMS, Clinical Data Management, Clinical Development, Clinical Research, Computer System..., Drug Development, EDC, FDA, GCP, GLP, GMP, Infectious Diseases, Medical Writing, Neurology, Oncology, Pharmaceutical Industry, Pharmaceutics, Pharmacovigilance, Quality Assurance, Regulatory Affairs, Regulatory Submissions, Sop, Technology Transfer
Education
Fairleigh Dickinson University
Debi Johnson's Eisai Medical Research Experience November 2005 - 2007
Job Manager Accounting & Financial Reporting, Eisai Inc.
Industry Pharmaceuticals
Experience
Eisai Inc. July 2007 - Present
Eisai Medical Research November 2005 - 2007
Education
Stockton University 1993 — 1997
Eisai Inc. July 2007 - Present
Eisai Medical Research November 2005 - 2007
Education
Stockton University 1993 — 1997
Dale Shuster's Eisai Medical Research Experience 2005 - 2010
Job Executive Director at Daiichi Sankyo Pharma Development
Industry Pharmaceuticals
Experience
Daiichi Sankyo Pharma Development April 2013 - Present
Daiichi Sankyo Pharma Development November 2010 - April 2013
Eisai Medical Research 2005 - 2010
Eisai Inc 2005 - 2010
Schering-Plough 1998 - 2005
American Cyanamid 1992 - 1998
Skills
Lifesciences, Oncology, Clinical Trials, Clinical Development, CRO, Drug Development, EDC, Drug Discovery, Pharmaceutical Industry, Biotechnology, Infectious Diseases, Therapeutic Areas, Biomarkers, Biopharmaceuticals, Immunology, GCP, Medical Writing, Cancer, Pharmacology, Medical Affairs, Diabetes, Pharmacovigilance, Hematology, Protocol, Regulatory Affairs, Neurology, Vaccines, Translational Medicine
Education
University of Kentucky 1983 — 1987
Daiichi Sankyo Pharma Development April 2013 - Present
Daiichi Sankyo Pharma Development November 2010 - April 2013
Eisai Medical Research 2005 - 2010
Eisai Inc 2005 - 2010
Schering-Plough 1998 - 2005
American Cyanamid 1992 - 1998
Skills
Lifesciences, Oncology, Clinical Trials, Clinical Development, CRO, Drug Development, EDC, Drug Discovery, Pharmaceutical Industry, Biotechnology, Infectious Diseases, Therapeutic Areas, Biomarkers, Biopharmaceuticals, Immunology, GCP, Medical Writing, Cancer, Pharmacology, Medical Affairs, Diabetes, Pharmacovigilance, Hematology, Protocol, Regulatory Affairs, Neurology, Vaccines, Translational Medicine
Education
University of Kentucky 1983 — 1987
Juanita Brown's Eisai Medical Research Experience October 2008 - June 2009
Job Senior Clinical Project Manager at Acorda Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Acorda Therapeutics, Inc. June 2010 - Present
Eisai Medical Research October 2008 - June 2009
Hoffmann La Roche August 2007 - September 2008
Pfizer August 1993 - August 2007
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Oncology, CRO, GCP, CTMS, 21 CFR Part 11
Education
Saint Peter's College 2008 — 2009
Master of Science (MS), Accountancy
Certified Project Management Professional (PMP)
Rensselaer at Hartford
MBA, Management
University of Connecticut
BS, Molecular & Cell Biology
Acorda Therapeutics, Inc. June 2010 - Present
Eisai Medical Research October 2008 - June 2009
Hoffmann La Roche August 2007 - September 2008
Pfizer August 1993 - August 2007
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Oncology, CRO, GCP, CTMS, 21 CFR Part 11
Education
Saint Peter's College 2008 — 2009
Master of Science (MS), Accountancy
Certified Project Management Professional (PMP)
Rensselaer at Hartford
MBA, Management
University of Connecticut
BS, Molecular & Cell Biology
Naseem Zojwalla's Eisai Medical Research Experience June 2005 - June 2008
Job Vice President of Clinical Development at Peloton Therapeutics
Industry Pharmaceuticals
Experience
Peloton Therapeutics March 2015 - Present
Onyx Pharmaceuticals June 2011 - Present
ImClone Systems August 2008 - May 2011
Eisai Medical Research June 2005 - June 2008
Education
Stanford University 1990 — 1994
Peloton Therapeutics March 2015 - Present
Onyx Pharmaceuticals June 2011 - Present
ImClone Systems August 2008 - May 2011
Eisai Medical Research June 2005 - June 2008
Education
Stanford University 1990 — 1994
Yaping Sun's Eisai Medical Research Experience 2009 - Present
Job Pharmaceuticals Consultant and Contractor
Industry Pharmaceuticals
Experience
Eisai Medical Research 2009 - Present
Eisai 2009 - 2011
Coulter Pharmaceutical 2001 - 2005
Purdue Pharma 2000 - 2005
Skills
CDISC, Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, SAS, Biostatistics, Medical Devices, Data Management, Clinical Data Management, Statistical Programming, EDC, FDA
Education
University of Florida 1990 — 2006
Eisai Medical Research 2009 - Present
Eisai 2009 - 2011
Coulter Pharmaceutical 2001 - 2005
Purdue Pharma 2000 - 2005
Skills
CDISC, Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, SAS, Biostatistics, Medical Devices, Data Management, Clinical Data Management, Statistical Programming, EDC, FDA
Education
University of Florida 1990 — 2006
Bipin Mistry's Eisai Medical Research Experience 2004 - Present
Job Associate Director, Eisai Inc.
Industry Pharmaceuticals
Experience
Eisai Inc. 2009 - Present
Eisai Medical Research 2004 - Present
Eisai Inc 2008 - 2009
Skills
Oncology, Clinical Pharmacology, Chemistry, Clinical Development, Translational Medicine
Education
University of Maryland Baltimore 1989 — 1999
Eisai Inc. 2009 - Present
Eisai Medical Research 2004 - Present
Eisai Inc 2008 - 2009
Skills
Oncology, Clinical Pharmacology, Chemistry, Clinical Development, Translational Medicine
Education
University of Maryland Baltimore 1989 — 1999
Carrie Beth Capone's Eisai Medical Research Experience December 2003 - April 2006
Job Clinical Quality and Compliance at sanofiaventis
Industry Pharmaceuticals
Experience
Sanofi April 2006 - Present
Eisai Medical Research December 2003 - April 2006
PTC Therapeutics January 2001 - December 2003
Skills
GCP, Quality Assurance, CRO, Clinical Development, Clinical Trials, CTMS, Sop, Pharmaceutical Industry, 21 CFR Part 11, GMP, EDC, Therapeutic Areas, Computer System..., FDA, Drug Development, Oncology, SOP
Education
American Society for Quality
CQA, Certified Quality Auditor
Northeastern University
Master's Degree, Regulatory Affairs
Rutgers University-New Brunswick
BS, Biology
Rutgers, The State University of New Jersey-Newark
MBA, Pharmaceutical Management
University of Medicine and Dentistry of New Jersey
MS, Biomedical Sciences
Sanofi April 2006 - Present
Eisai Medical Research December 2003 - April 2006
PTC Therapeutics January 2001 - December 2003
Skills
GCP, Quality Assurance, CRO, Clinical Development, Clinical Trials, CTMS, Sop, Pharmaceutical Industry, 21 CFR Part 11, GMP, EDC, Therapeutic Areas, Computer System..., FDA, Drug Development, Oncology, SOP
Education
American Society for Quality
CQA, Certified Quality Auditor
Northeastern University
Master's Degree, Regulatory Affairs
Rutgers University-New Brunswick
BS, Biology
Rutgers, The State University of New Jersey-Newark
MBA, Pharmaceutical Management
University of Medicine and Dentistry of New Jersey
MS, Biomedical Sciences
Janet Garzieri's Eisai Medical Research Experience July 2004 - January 2006
Job HR Specialist at Hankook Tire America
Industry Automotive
Experience
Hankook Tire America May 2007 - Present
Eisai Medical Research July 2004 - January 2006
Schratter Foods ( ANCO Fine Cheese ) April 2000 - May 2004
Schiapparelli Biosystems, Inc. (now Alfa-Wassermann) 1994 - 2000
Skills
Talent Management, Human Resources, Talent Acquisition, Employee Relations, Executive Search, Training, Onboarding, Workforce Planning, HRIS, Succession Planning, Applicant Tracking..., New Hire Orientations, Deferred Compensation, Temporary Placement, College Recruiting
Education
Saint Bonaventure University 1965 — 1969
Bachelor of Arts (BA), psychology
William Paterson University of New Jersey
Education
Hankook Tire America May 2007 - Present
Eisai Medical Research July 2004 - January 2006
Schratter Foods ( ANCO Fine Cheese ) April 2000 - May 2004
Schiapparelli Biosystems, Inc. (now Alfa-Wassermann) 1994 - 2000
Skills
Talent Management, Human Resources, Talent Acquisition, Employee Relations, Executive Search, Training, Onboarding, Workforce Planning, HRIS, Succession Planning, Applicant Tracking..., New Hire Orientations, Deferred Compensation, Temporary Placement, College Recruiting
Education
Saint Bonaventure University 1965 — 1969
Bachelor of Arts (BA), psychology
William Paterson University of New Jersey
Education
Chean Eng Ooi's Eisai Medical Research Experience 2008 - Present
Job Senior Clinical Research Scientist at Eisai Medical Research
Industry Biotechnology
Experience
Eisai Medical Research 2008 - Present
CuraGen Corporation 1999 - 2008
National Institutes of Health July 1993 - December 1998
Education
New York University School of Medicine 1987 — 1991
Eisai Medical Research 2008 - Present
CuraGen Corporation 1999 - 2008
National Institutes of Health July 1993 - December 1998
Education
New York University School of Medicine 1987 — 1991
Hugh Hem-Lee's Eisai Medical Research Experience April 2005 - May 2007
Job President at HemLee Clinical
Industry Pharmaceuticals
Experience
Hem-Lee Clinical 2011 - Present
Biodel Inc. March 2008 - January 2011
Hem-Lee Clinical 2011 - 2011
Pfizer May 2007 - December 2007
Eisai Medical Research April 2005 - May 2007
Quintiles Transnational Corporation July 1999 - April 2005
Quintiles 1999 - 2005
Skills
CRO, Diabetes, Clinical Trials, Regulatory Requirements, Therapists, GCP, Regulatory Submissions, Protocol, Sop, Clinical Research, Clinical Development, Phase I, EDC
Education
Kennesaw State University - Michael J. Coles College of Business 2003 — 2005
MBA, General Business
Eastern Kentucky University 1979 — 1983
BS/BA, Microbiology/Chemisry
Eastern Kentucky University
MS, Biology
New York University
Hem-Lee Clinical 2011 - Present
Biodel Inc. March 2008 - January 2011
Hem-Lee Clinical 2011 - 2011
Pfizer May 2007 - December 2007
Eisai Medical Research April 2005 - May 2007
Quintiles Transnational Corporation July 1999 - April 2005
Quintiles 1999 - 2005
Skills
CRO, Diabetes, Clinical Trials, Regulatory Requirements, Therapists, GCP, Regulatory Submissions, Protocol, Sop, Clinical Research, Clinical Development, Phase I, EDC
Education
Kennesaw State University - Michael J. Coles College of Business 2003 — 2005
MBA, General Business
Eastern Kentucky University 1979 — 1983
BS/BA, Microbiology/Chemisry
Eastern Kentucky University
MS, Biology
New York University
Mark Taisey's Eisai Medical Research Experience September 2007 - June 2009
Job Vice President Global Regulatory Affairs at Amgen
Industry Pharmaceuticals
Experience
Amgen January 2014 - Present
Eisai, Inc. June 2009 - December 2013
Eisai Medical Research September 2007 - June 2009
Pfizer 2002 - 2007
DuPont Pharmaceuticals 1992 - 2001
GD Searle and Co. 1988 - 1992
Sterling Drug, Inc 1986 - 1988
Vitarine Pharmaceuticals 1984 - 1988
Education
University of Delaware 2000 — 2010
Eisenhower College 1976 — 1986
University of Rochester 1982 — 1984
Rochester Institute of Technology 1980 — 1984
North Syracuse High School 1976 — 1980
Amgen January 2014 - Present
Eisai, Inc. June 2009 - December 2013
Eisai Medical Research September 2007 - June 2009
Pfizer 2002 - 2007
DuPont Pharmaceuticals 1992 - 2001
GD Searle and Co. 1988 - 1992
Sterling Drug, Inc 1986 - 1988
Vitarine Pharmaceuticals 1984 - 1988
Education
University of Delaware 2000 — 2010
Eisenhower College 1976 — 1986
University of Rochester 1982 — 1984
Rochester Institute of Technology 1980 — 1984
North Syracuse High School 1976 — 1980
Anna Kowal's Eisai Medical Research Experience November 2007 - May 2009
Job Research Compliance Manager at Atlantic Health
Industry Pharmaceuticals
Experience
Atlantic Health February 2013 - Present
Eisai May 2009 - January 2013
Eisai Medical Research November 2007 - May 2009
Damiano Pharmacy January 1998 - December 2006
Skills
Pharmaceutical Industry, Quality Assurance, GCP, Sop, Clinical Research, 21 CFR Part 11, FDA
Education
Drexel University 2010 — 2014
MS
Rutgers, The State University of New Jersey-Newark 2002 — 2006
BA
Atlantic Health February 2013 - Present
Eisai May 2009 - January 2013
Eisai Medical Research November 2007 - May 2009
Damiano Pharmacy January 1998 - December 2006
Skills
Pharmaceutical Industry, Quality Assurance, GCP, Sop, Clinical Research, 21 CFR Part 11, FDA
Education
Drexel University 2010 — 2014
MS
Rutgers, The State University of New Jersey-Newark 2002 — 2006
BA
Thomas Gnas's Eisai Medical Research Experience June 2006 - March 2011
Job Instructional Design Training Manager at AIG
Industry Pharmaceuticals
Experience
AIG January 2015 - Present
AIG April 2012 - December 2014
Eisai Medical Research June 2006 - March 2011
Schering-Plough 2001 - 2006
Skills
Pharmaceutical Industry, Learning Management..., Training, Document Management, 21 CFR Part 11, Sop, Quality Assurance, Clinical Development, Change Control, CRO, GxP, Software Documentation, Clinical Trials, FDA, GCP, Regulatory Affairs, Computer System..., Cross-functional Team..., CTMS, GMP, Validation, Data Management, SharePoint, Talent Management, WBTs, Adobe eLearning Suite, Lectora, Captivate, Blended Learning, Learning Management, Technical Writing, ADDIE, Instructional Design, Instructor-led Training, Visio, SOP
Education
NYU 2010 — 2012
Master's degree, Digital Media Design for Learning, 3.78
Kean University 1996 — 2001
BS, Computer Science - Management Information Systems
AIG January 2015 - Present
AIG April 2012 - December 2014
Eisai Medical Research June 2006 - March 2011
Schering-Plough 2001 - 2006
Skills
Pharmaceutical Industry, Learning Management..., Training, Document Management, 21 CFR Part 11, Sop, Quality Assurance, Clinical Development, Change Control, CRO, GxP, Software Documentation, Clinical Trials, FDA, GCP, Regulatory Affairs, Computer System..., Cross-functional Team..., CTMS, GMP, Validation, Data Management, SharePoint, Talent Management, WBTs, Adobe eLearning Suite, Lectora, Captivate, Blended Learning, Learning Management, Technical Writing, ADDIE, Instructional Design, Instructor-led Training, Visio, SOP
Education
NYU 2010 — 2012
Master's degree, Digital Media Design for Learning, 3.78
Kean University 1996 — 2001
BS, Computer Science - Management Information Systems
Soyoung Yun's Eisai Medical Research Experience December 2008 - April 2011
Job Sr. Manager, Clinical Operations at Eisai Medical Research
Industry Biotechnology
Experience
Eisai Medical Research December 2008 - April 2011
GPC Biotech August 2003 - November 2008
Education
Rutgers, The State University of New Jersey-Newark 1991 — 1995
BS, Biology
Eisai Medical Research December 2008 - April 2011
GPC Biotech August 2003 - November 2008
Education
Rutgers, The State University of New Jersey-Newark 1991 — 1995
BS, Biology
Murali Kajur's Eisai Medical Research Experience September 2008 - September 2009
Job Principal Statistical Programmer at Shionogi Inc.
Industry Pharmaceuticals
Experience
Shionogi Inc. June 2012 - Present
Sunovion Pharmaceuticals Inc. June 2011 - May 2012
United BioSource Corporation November 2010 - April 2011
Covance October 2009 - October 2010
Eisai Medical Research September 2008 - September 2009
MGI Pharma September 2005 - August 2008
Alkermes December 2004 - August 2005
Pfizer Pharmaceuticals 2004 - November 2004
UCB Pharma July 2002 - December 2003
Skills
CDISC, Clinical Data Management, CRO, Clinical Trials, EDC, Biostatistics, Oracle Clinical, Pharmaceutical Industry, Clinical Development, SDTM, SAS programming
Education
Sri Venkateswara University 1986 — 1992
Ph.D, Chemistry
Shionogi Inc. June 2012 - Present
Sunovion Pharmaceuticals Inc. June 2011 - May 2012
United BioSource Corporation November 2010 - April 2011
Covance October 2009 - October 2010
Eisai Medical Research September 2008 - September 2009
MGI Pharma September 2005 - August 2008
Alkermes December 2004 - August 2005
Pfizer Pharmaceuticals 2004 - November 2004
UCB Pharma July 2002 - December 2003
Skills
CDISC, Clinical Data Management, CRO, Clinical Trials, EDC, Biostatistics, Oracle Clinical, Pharmaceutical Industry, Clinical Development, SDTM, SAS programming
Education
Sri Venkateswara University 1986 — 1992
Ph.D, Chemistry
Chuan Zheng's Eisai Medical Research Experience 2006 - 2007
Job Senior Director, Biologics Sourcing at Patheon
Industry Pharmaceuticals
Experience
Patheon May 2015 - Present
Cubist Pharmaceuticals June 2013 - May 2015
Bristol-Myers Squipp 2008 - 2013
Eisai Medical Research 2006 - 2007
Bristol-Myers Squibb 2005 - 2006
Bristol-Myers Squibb 2003 - 2005
Skills
Biotechnology, Life Sciences, Pharmaceutical Industry, Clinical Development, Drug Development, Biopharmaceuticals, Technology Transfer, Protein Chemistry, Drug Discovery, R&D, Outsourcing, Forecasting, Project Management
Education
The University of Texas at Austin 1998 — 2000
Master of Business Administration (MBA), Finance and Operation
University of Michigan Medical School 1988 — 1994
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Peking University
Bachelor of Science (BS), Biochemistry
Patheon May 2015 - Present
Cubist Pharmaceuticals June 2013 - May 2015
Bristol-Myers Squipp 2008 - 2013
Eisai Medical Research 2006 - 2007
Bristol-Myers Squibb 2005 - 2006
Bristol-Myers Squibb 2003 - 2005
Skills
Biotechnology, Life Sciences, Pharmaceutical Industry, Clinical Development, Drug Development, Biopharmaceuticals, Technology Transfer, Protein Chemistry, Drug Discovery, R&D, Outsourcing, Forecasting, Project Management
Education
The University of Texas at Austin 1998 — 2000
Master of Business Administration (MBA), Finance and Operation
University of Michigan Medical School 1988 — 1994
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Peking University
Bachelor of Science (BS), Biochemistry
Chris Capone's Eisai Medical Research Experience 2003 - 2006
Job Security Systems & Disaster Control Administrator at SunGard
Industry Information Technology and Services
Experience
SunGard November 2011 - Present
SunGard February 2008 - November 2011
ARGI 2007 - 2008
AIG July 2007 - December 2007
Networks Work November 2006 - July 2007
Eisai Medical Research 2003 - 2006
Skills
Active Directory, VMware, Microsoft Operating..., Disaster Recovery, ITIL Certified, Business Continuity, Technical Support, Troubleshooting, VMware Infrastructure, VPN, Cisco Technologies, Management, Microsoft Exchange, Security, Network Security, Windows Server, Data Center, System Deployment, Firewalls, VMware ESX, DNS, Cloud Computing, IT Operations, IT Service Management, Incident Management, Network Administration, Network Architecture, Solaris, Unix
Education
American Intercontinental University 2006 — 2006
IT Management
The Chubb Institute 2001 — 2001
Diploma, Computer Technical Support
SunGard November 2011 - Present
SunGard February 2008 - November 2011
ARGI 2007 - 2008
AIG July 2007 - December 2007
Networks Work November 2006 - July 2007
Eisai Medical Research 2003 - 2006
Skills
Active Directory, VMware, Microsoft Operating..., Disaster Recovery, ITIL Certified, Business Continuity, Technical Support, Troubleshooting, VMware Infrastructure, VPN, Cisco Technologies, Management, Microsoft Exchange, Security, Network Security, Windows Server, Data Center, System Deployment, Firewalls, VMware ESX, DNS, Cloud Computing, IT Operations, IT Service Management, Incident Management, Network Administration, Network Architecture, Solaris, Unix
Education
American Intercontinental University 2006 — 2006
IT Management
The Chubb Institute 2001 — 2001
Diploma, Computer Technical Support
Lee Golden's Eisai Medical Research Experience November 2009 - August 2011
Job SVP, Therapeutic Business Unit Head CV, Pulmonary and CNS at Mesoblast
Industry Biotechnology
Experience
Mesoblast July 2011 - Present
Eisai Medical Research November 2009 - August 2011
Novartis Pharmaceuticals March 2009 - November 2009
Elan Pharmaceuticals March 2008 - March 2009
Actelion Pharmaceuticals January 2005 - March 2008
Pfizer Pharmaceuticals 2001 - 2005
pfizer 2001 - 2005
Skills
Clinical Trials, Clinical Development, Medical Affairs, Pharmaceutical Industry, Infectious Diseases, GCP, Market Access, Urology, Biotechnology, CRO, Diabetes, Neurology, FDA, Commercialization, Therapeutic Areas, Drug Development, Regulatory Affairs, Lifesciences, Medicine, Biopharmaceuticals, Medical Writing, CTMS, Neuroscience, Oncology, Clinical Research, Pharmacovigilance, Rheumatology, Cardiology, Immunology, Life Sciences, Regulatory Submissions
Education
New York University School of Medicine 1989 — 1993
Doctor of Medicine (MD)
University of Michigan 1985 — 1989
Bachelor of Science (BS), Physiological Psychology/Psychobiology
Mesoblast July 2011 - Present
Eisai Medical Research November 2009 - August 2011
Novartis Pharmaceuticals March 2009 - November 2009
Elan Pharmaceuticals March 2008 - March 2009
Actelion Pharmaceuticals January 2005 - March 2008
Pfizer Pharmaceuticals 2001 - 2005
pfizer 2001 - 2005
Skills
Clinical Trials, Clinical Development, Medical Affairs, Pharmaceutical Industry, Infectious Diseases, GCP, Market Access, Urology, Biotechnology, CRO, Diabetes, Neurology, FDA, Commercialization, Therapeutic Areas, Drug Development, Regulatory Affairs, Lifesciences, Medicine, Biopharmaceuticals, Medical Writing, CTMS, Neuroscience, Oncology, Clinical Research, Pharmacovigilance, Rheumatology, Cardiology, Immunology, Life Sciences, Regulatory Submissions
Education
New York University School of Medicine 1989 — 1993
Doctor of Medicine (MD)
University of Michigan 1985 — 1989
Bachelor of Science (BS), Physiological Psychology/Psychobiology
Terri Goldberg's Eisai Medical Research Experience Associate Director, Project Management - OncologyEisai Pharmaceuticals2006 - Present
Job Associate Director, Project Management at Eisai Medical research
Industry Pharmaceuticals
Experience
Eisai Medical research Associate Director, Project Management - OncologyEisai Pharmaceuticals2006 - Present
Education
University at Albany, SUNY 1971 — 1975
Eisai Medical research Associate Director, Project Management - OncologyEisai Pharmaceuticals2006 - Present
Education
University at Albany, SUNY 1971 — 1975
Akhil Baranwal's Eisai Medical Research Experience January 2008 - Present
Job Medical Director at Eisai
Industry Pharmaceuticals
Experience
Eisai Medical Research January 2008 - Present
MGI Pharma August 2007 - January 2008
GSK July 2005 - July 2007
Education
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School 1999 — 2002
Fellowship, Oncology
State University of New York Downstate Medical Center College of Medicine 1996 — 1999
Residency, Internal Medicine
All India Institute of Medical Sciences 1990 — 1995
MD
Kendriya Vidyalaya 1978 — 1990
High School
Eisai Medical Research January 2008 - Present
MGI Pharma August 2007 - January 2008
GSK July 2005 - July 2007
Education
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School 1999 — 2002
Fellowship, Oncology
State University of New York Downstate Medical Center College of Medicine 1996 — 1999
Residency, Internal Medicine
All India Institute of Medical Sciences 1990 — 1995
MD
Kendriya Vidyalaya 1978 — 1990
High School
Thomas Broadbent's Eisai Medical Research Experience March 2006 - Present
Job Associate Director at Eisai, Inc.
Industry Pharmaceuticals
Experience
Eisai Medical Research March 2006 - Present
FDA 1998 - 2006
Skills
Regulatory Affairs, FDA, Chemistry, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Pharmaceuticals, IND, Biotechnology
Education
Rensselaer Polytechnic Institute 1988 — 1993
Ph.D., Organic Chemistry
Eisai Medical Research March 2006 - Present
FDA 1998 - 2006
Skills
Regulatory Affairs, FDA, Chemistry, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Pharmaceuticals, IND, Biotechnology
Education
Rensselaer Polytechnic Institute 1988 — 1993
Ph.D., Organic Chemistry
Leonard Oppenheimer's Eisai Medical Research Experience October 2004 - January 2006
Job Senior Director Cardiovascular/Urology
Industry Pharmaceuticals
Experience
J&J February 2009 - Present
Johnson & Johnson 2006 - Present
Johnson & Johnson 2006 - 2009
Eisai Medical Research October 2004 - January 2006
merck research laboratories July 1977 - September 2004
Merck 1977 - 2004
Education
University of North Carolina at Chapel Hill 1966 — 1971
PhD, Biostatistics
City University of New York City College 1962 — 1966
BS, Mathematics
City University of New York-Brooklyn College 1962 — 1966
J&J February 2009 - Present
Johnson & Johnson 2006 - Present
Johnson & Johnson 2006 - 2009
Eisai Medical Research October 2004 - January 2006
merck research laboratories July 1977 - September 2004
Merck 1977 - 2004
Education
University of North Carolina at Chapel Hill 1966 — 1971
PhD, Biostatistics
City University of New York City College 1962 — 1966
BS, Mathematics
City University of New York-Brooklyn College 1962 — 1966
Jeff Liebman's Eisai Medical Research Experience 2006 - Present
Job Medical Writer at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research 2006 - Present
CIBA-GEIGY/Novartis November 1987 - December 2004
CIBA-GEIGY 1983 - 1987
Skills
Pharmacology, Medical Writing, Pharmaceutical Industry, Oncology, Clinical Development, Biotechnology
Education
UCLA 1968 — 1973
PhD, Physiological Psychology
Oberlin College 1964 — 1968
B.A., Psychology
Eisai Medical Research 2006 - Present
CIBA-GEIGY/Novartis November 1987 - December 2004
CIBA-GEIGY 1983 - 1987
Skills
Pharmacology, Medical Writing, Pharmaceutical Industry, Oncology, Clinical Development, Biotechnology
Education
UCLA 1968 — 1973
PhD, Physiological Psychology
Oberlin College 1964 — 1968
B.A., Psychology
Alexandra Bershadsky's Eisai Medical Research Experience March 2007 - March 2008
Job Senior Associate Technology Support Specialist at Ernst & Young
Industry Accounting
Experience
Ernst & Young August 2011 - Present
Ernst & Young March 2008 - August 2011
Eisai Medical Research March 2007 - March 2008
Langan Engineering 2001 - 2003
Skills
Active Directory, Lotus Notes, Citrix, XP, SharePoint, Outlook, iPass, Project Management, Team Leadership, IT Service Management, PowerPoint, Microsoft Excel, PMP, New Hire Training, Emerging Technologies, Integration, Technical Support, Microsoft Office, Windows XP, Business Analysis, ITIL, Information Technology, Management, Software Documentation
Education
Rutgers University-New Brunswick 2000 — 2004
Bachelor's degree, Information Technology
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2004
BS, Information Technology
Ernst & Young August 2011 - Present
Ernst & Young March 2008 - August 2011
Eisai Medical Research March 2007 - March 2008
Langan Engineering 2001 - 2003
Skills
Active Directory, Lotus Notes, Citrix, XP, SharePoint, Outlook, iPass, Project Management, Team Leadership, IT Service Management, PowerPoint, Microsoft Excel, PMP, New Hire Training, Emerging Technologies, Integration, Technical Support, Microsoft Office, Windows XP, Business Analysis, ITIL, Information Technology, Management, Software Documentation
Education
Rutgers University-New Brunswick 2000 — 2004
Bachelor's degree, Information Technology
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2004
BS, Information Technology
Shari Coslett's Eisai Medical Research Experience September 2005 - December 2010
Job Director, Clinical Operations at Purdue Pharma L.P.
Industry Pharmaceuticals
Experience
Axovant Sciences, Inc. July 2015 - Present
Purdue Pharma L.P. June 2014 - July 2015
Purdue Pharma L.P. 2010 - June 2014
Eisai Medical Research September 2005 - December 2010
Acorda Therapeutics 2000 - 2005
SCP 1998 - 2000
Skills
Clinical Development, Clinical Trials, CTMS, Pharmaceutical Industry, GCP, CRO, Clinical Research, Clinical Operations, EDC, Drug Development, Clinical Monitoring, Sop, Therapeutic Areas, Regulatory Affairs, Oncology, Healthcare, Regulatory Submissions, Psychiatry, Neuroscience, FDA
Education
Carleton University 1982 — 1986
Axovant Sciences, Inc. July 2015 - Present
Purdue Pharma L.P. June 2014 - July 2015
Purdue Pharma L.P. 2010 - June 2014
Eisai Medical Research September 2005 - December 2010
Acorda Therapeutics 2000 - 2005
SCP 1998 - 2000
Skills
Clinical Development, Clinical Trials, CTMS, Pharmaceutical Industry, GCP, CRO, Clinical Research, Clinical Operations, EDC, Drug Development, Clinical Monitoring, Sop, Therapeutic Areas, Regulatory Affairs, Oncology, Healthcare, Regulatory Submissions, Psychiatry, Neuroscience, FDA
Education
Carleton University 1982 — 1986
Shigang Shen's Eisai Medical Research Experience October 2008 - January 2012
Job Contract SAS Programmer at AVEO Oncology
Industry Pharmaceuticals
Experience
AVEO Oncology July 2012 - Present
sanofi-aventis January 2012 - June 2012
Eisai Medical Research October 2008 - January 2012
MGI Pharma August 2007 - October 2008
Wyeth March 2004 - December 2005
Skills
Clinical Trials, SAS, Oncology, EDC, Clinical Research, CDISC, ISS SUBMISSION, ISE SUBMISSION, FDA
Education
Oregon Institute of Technology 1996 — 2000
Master, Molecular Biology and Biochemistry
TIANJIN MEDICAL UNIVERSITY 1984 — 1992
M.D., Medicine
Tianjin Second High School
AVEO Oncology July 2012 - Present
sanofi-aventis January 2012 - June 2012
Eisai Medical Research October 2008 - January 2012
MGI Pharma August 2007 - October 2008
Wyeth March 2004 - December 2005
Skills
Clinical Trials, SAS, Oncology, EDC, Clinical Research, CDISC, ISS SUBMISSION, ISE SUBMISSION, FDA
Education
Oregon Institute of Technology 1996 — 2000
Master, Molecular Biology and Biochemistry
TIANJIN MEDICAL UNIVERSITY 1984 — 1992
M.D., Medicine
Tianjin Second High School
C. Michael Doroshuk's Eisai Medical Research Experience 2005 - 2008
Job Director, Regulatory Affairs at Eisai Inc
Industry Pharmaceuticals
Experience
Eisai, Inc October 2008 - Present
Eisai Medical Research 2005 - 2008
Berlex, Inc. March 2001 - October 2005
Berlex Laboratories 1992 - 2001
Berlex Laboratories 1991 - 1992
Berlex Laboratories 1986 - 1991
Skills
IND, Clinical Development, Regulatory Affairs, Regulatory Submissions, Drug Development, eCTD, FDA, Clinical Trials, Pharmaceutical Industry, EDC, Oncology, GCP, CTMS, CRO, Therapeutic Areas, Pharmacovigilance
Education
North Carolina State University 1978 — 1981
Bachelor of Science (BS), biology, animal science
Fairleigh Dickinson University 1974 — 1978
BS, Biology
Eisai, Inc October 2008 - Present
Eisai Medical Research 2005 - 2008
Berlex, Inc. March 2001 - October 2005
Berlex Laboratories 1992 - 2001
Berlex Laboratories 1991 - 1992
Berlex Laboratories 1986 - 1991
Skills
IND, Clinical Development, Regulatory Affairs, Regulatory Submissions, Drug Development, eCTD, FDA, Clinical Trials, Pharmaceutical Industry, EDC, Oncology, GCP, CTMS, CRO, Therapeutic Areas, Pharmacovigilance
Education
North Carolina State University 1978 — 1981
Bachelor of Science (BS), biology, animal science
Fairleigh Dickinson University 1974 — 1978
BS, Biology
Richard Petrisko's Eisai Medical Research Experience 2008 - 2008
Job Senior Clinical Affairs Project Manger III at GE Healthcare
Industry Biotechnology
Experience
GE Healthcare May 2013 - Present
Novartis March 2010 - February 2011
TKL Research March 2009 - April 2010
Eisai Medical Research 2008 - 2008
Skills
Clinical Research, Clinical Development, CTMS, Clinical Trials, CRO, GCP, Pharmaceutical Industry, Oncology, EDC, Infectious Diseases, Biotechnology, Clinical Monitoring
Education
Kansas State University 1993 — 1996
MS, Kinesiology
Alfred University 1989 — 1993
BA, Sports Medicine
GE Healthcare May 2013 - Present
Novartis March 2010 - February 2011
TKL Research March 2009 - April 2010
Eisai Medical Research 2008 - 2008
Skills
Clinical Research, Clinical Development, CTMS, Clinical Trials, CRO, GCP, Pharmaceutical Industry, Oncology, EDC, Infectious Diseases, Biotechnology, Clinical Monitoring
Education
Kansas State University 1993 — 1996
MS, Kinesiology
Alfred University 1989 — 1993
BA, Sports Medicine
Ruta Slepetys's Eisai Medical Research Experience 2009 - 2012
Job contract medical writer
Industry Pharmaceuticals
Experience
Eisai Inc July 2012 - Present
Exelixis 2011 - Present
ClinCon Research Inc 2011 - July 2012
Eisai Medical Research 2009 - 2012
sanofi-aventis 2004 - 2009
Duck Flats Pharma 2005 - 2008
Schering-Plough Research Institute 2001 - 2004
Schering-Plough Research Institute 1997 - 1998
Schering-Plough Pharmaceuticals 1996 - 1997
Schering-Plough Research Institute 1994 - 1996
Skills
Medical Writing, Oncology, Clinical Trials, Neuroscience, Clinical Development, Drug Development, Vaccines, CRO, Sop, GLP, Validation, Protocol, Regulatory Affairs, Clinical Research, FDA, Medicine, IND, Pharmaceutical Industry, GMP, Lifesciences, GCP, Regulatory Submissions, CTMS
Education
Fairleigh Dickinson University 1991 — 1997
MBA, Pharmaceutical/Chemical specialty
Rutgers University-New Brunswick 1974 — 1978
BS, Animal Science
Eisai Inc July 2012 - Present
Exelixis 2011 - Present
ClinCon Research Inc 2011 - July 2012
Eisai Medical Research 2009 - 2012
sanofi-aventis 2004 - 2009
Duck Flats Pharma 2005 - 2008
Schering-Plough Research Institute 2001 - 2004
Schering-Plough Research Institute 1997 - 1998
Schering-Plough Pharmaceuticals 1996 - 1997
Schering-Plough Research Institute 1994 - 1996
Skills
Medical Writing, Oncology, Clinical Trials, Neuroscience, Clinical Development, Drug Development, Vaccines, CRO, Sop, GLP, Validation, Protocol, Regulatory Affairs, Clinical Research, FDA, Medicine, IND, Pharmaceutical Industry, GMP, Lifesciences, GCP, Regulatory Submissions, CTMS
Education
Fairleigh Dickinson University 1991 — 1997
MBA, Pharmaceutical/Chemical specialty
Rutgers University-New Brunswick 1974 — 1978
BS, Animal Science
David Kao, Pharm.D.'s Eisai Medical Research Experience June 2002 - December 2008
Job Sr. Director, Regulatory Affairs at Daiichi Sankyo
Industry Pharmaceuticals
Experience
Receptos, Inc. July 2015 - Present
Daiichi Sankyo June 2011 - July 2015
Roche Pharmaceuticals January 2009 - June 2011
Eisai Medical Research June 2002 - December 2008
Merck 1999 - 2002
SmithKline Beecham 1998 - 1999
Wyeth Consumer Healthcare - American Home Products 1996 - 1998
Flemington Medical Center 1995 - 1996
Wyeth Consumer Healthcare 1994 - 1995
Skills
21 CFR Part 11, Biopharmaceuticals, Biotechnology, CRO, CTMS, Clinical Development, Clinical Trials, Drug Development, Drug Safety, EDC, FDA, GCP, IND, Infectious Diseases, Lifesciences, Oncology, Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, Regulatory Requirements, Sop, Pharmaceutics, Regulatory Submissions, Therapeutic Areas, SOP
Education
Shenandoah University 2012 — 2014
PharmD
Rutgers, The State University of New Jersey-Newark 2000 — 2006
MBA, Marketing
Rutgers University-New Brunswick 1989 — 1994
BS, Pharmacy
Receptos, Inc. July 2015 - Present
Daiichi Sankyo June 2011 - July 2015
Roche Pharmaceuticals January 2009 - June 2011
Eisai Medical Research June 2002 - December 2008
Merck 1999 - 2002
SmithKline Beecham 1998 - 1999
Wyeth Consumer Healthcare - American Home Products 1996 - 1998
Flemington Medical Center 1995 - 1996
Wyeth Consumer Healthcare 1994 - 1995
Skills
21 CFR Part 11, Biopharmaceuticals, Biotechnology, CRO, CTMS, Clinical Development, Clinical Trials, Drug Development, Drug Safety, EDC, FDA, GCP, IND, Infectious Diseases, Lifesciences, Oncology, Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, Regulatory Requirements, Sop, Pharmaceutics, Regulatory Submissions, Therapeutic Areas, SOP
Education
Shenandoah University 2012 — 2014
PharmD
Rutgers, The State University of New Jersey-Newark 2000 — 2006
MBA, Marketing
Rutgers University-New Brunswick 1989 — 1994
BS, Pharmacy
Joey Galang's Eisai Medical Research Experience October 2002 - January 2007
Job Alliance Manager, Service Provider Management, PDBCDM, Genentech
Industry Pharmaceuticals
Experience
Genentech May 2010 - Present
Hoffmann-La Roche January 2007 - May 2010
Eisai Medical Research October 2002 - January 2007
Forest Laboratories April 2001 - October 2002
Covance May 1999 - March 2001
CTRC Institute for Drug Development November 1997 - May 1999
Skills
Pharmacovigilance, GCP, CRO, Quality Assurance, EDC, Clinical Trials, 21 CFR Part 11, Clinical Data Management, CTMS, Oncology, Drug Development, Data Management, Clinical Development, Sop, Computer System..., Therapeutic Areas, Biotechnology, Pharmaceutical Industry, FDA, ICH-GCP, Regulatory Submissions, SOP
Education
Far Eastern University 1977 — 1981
Bachelor of Science, Chemistry
Genentech May 2010 - Present
Hoffmann-La Roche January 2007 - May 2010
Eisai Medical Research October 2002 - January 2007
Forest Laboratories April 2001 - October 2002
Covance May 1999 - March 2001
CTRC Institute for Drug Development November 1997 - May 1999
Skills
Pharmacovigilance, GCP, CRO, Quality Assurance, EDC, Clinical Trials, 21 CFR Part 11, Clinical Data Management, CTMS, Oncology, Drug Development, Data Management, Clinical Development, Sop, Computer System..., Therapeutic Areas, Biotechnology, Pharmaceutical Industry, FDA, ICH-GCP, Regulatory Submissions, SOP
Education
Far Eastern University 1977 — 1981
Bachelor of Science, Chemistry
Ray Heimbuch's Eisai Medical Research Experience December 2008 - Present
Job SAS Consultant for Pharmaceutical trial support
Industry Pharmaceuticals
Experience
Eisai Medical Research December 2008 - Present
Comsys Information Technology Services Inc. May 2008 - October 2009
COMSYS May 2008 - October 2009
Pfizer March 2008 - October 2009
Allergan Pharmaceuticals November 2008 - June 2009
Novartis August 1998 - May 2008
Bristol-Myers Squibb, Products Division August 1985 - August 1994
Ortho-McNeil Pharmaceutical August 1982 - August 1985
Schering-Plough Pharmaceuticals August 1980 - August 1982
Yale University School of Medicine February 1976 - August 1980
Skills
SAS programming, Clinical Data Management, CDISC, Biostatistics, SAS, EDC, Pharmaceutical Industry, CRO, Clinical Research, GCP, 21 CFR Part 11, Data Management, Clinical Development, Validation, Statistics, Data Analysis, Oncology, Statistical Programming, CTMS, Regulatory Submissions, Computer System..., Pharmacovigilance, Drug Development, Protocol
Education
Yale University 1970 — 1973
MPhil, Physical Anthropology
University of California, Davis 1965 — 1970
BS, Genetics
Eisai Medical Research December 2008 - Present
Comsys Information Technology Services Inc. May 2008 - October 2009
COMSYS May 2008 - October 2009
Pfizer March 2008 - October 2009
Allergan Pharmaceuticals November 2008 - June 2009
Novartis August 1998 - May 2008
Bristol-Myers Squibb, Products Division August 1985 - August 1994
Ortho-McNeil Pharmaceutical August 1982 - August 1985
Schering-Plough Pharmaceuticals August 1980 - August 1982
Yale University School of Medicine February 1976 - August 1980
Skills
SAS programming, Clinical Data Management, CDISC, Biostatistics, SAS, EDC, Pharmaceutical Industry, CRO, Clinical Research, GCP, 21 CFR Part 11, Data Management, Clinical Development, Validation, Statistics, Data Analysis, Oncology, Statistical Programming, CTMS, Regulatory Submissions, Computer System..., Pharmacovigilance, Drug Development, Protocol
Education
Yale University 1970 — 1973
MPhil, Physical Anthropology
University of California, Davis 1965 — 1970
BS, Genetics
Damon Daulerio's Eisai Medical Research Experience January 2003 - August 2005
Job Head, Product Support, Pharma at Alcon, a Novartis company
Industry Pharmaceuticals
Experience
Alcon, a Novartis company December 2014 - Present
Neos Therapeutics June 2013 - December 2014
Boehringer Ingelheim Pharmaceuticals August 2005 - June 2013
Eisai Medical Research January 2003 - August 2005
Purdue Pharma August 1996 - December 2002
Skills
Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Regulatory Affairs, Clinical Trials, GCP, Drug Development, FDA, Regulatory Requirements, Therapeutic Areas, Biotechnology, CTMS, Pharmaceutics, IND, eCTD, NDA
Education
Fairfield University 1998 — 2002
MBA, International Business
Fairfield University 1992 — 1996
BS, Biology
Alcon, a Novartis company December 2014 - Present
Neos Therapeutics June 2013 - December 2014
Boehringer Ingelheim Pharmaceuticals August 2005 - June 2013
Eisai Medical Research January 2003 - August 2005
Purdue Pharma August 1996 - December 2002
Skills
Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Regulatory Affairs, Clinical Trials, GCP, Drug Development, FDA, Regulatory Requirements, Therapeutic Areas, Biotechnology, CTMS, Pharmaceutics, IND, eCTD, NDA
Education
Fairfield University 1998 — 2002
MBA, International Business
Fairfield University 1992 — 1996
BS, Biology
Jason Tran, PMP's Eisai Medical Research Experience October 2004 - October 2007
Job Director, Therapeutic Area Project Management Oncology
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals April 2012 - Present
Roche Pharmaceuticals July 2011 - April 2012
Roche Pharmaceuticals October 2007 - April 2012
Eisai Medical Research October 2004 - October 2007
J & J PRD, L.L.C July 2003 - February 2004
Pharmacia Corp May 2002 - June 2003
Lavipharm Corp. September 2000 - May 2002
Skills
Oncology, Pharmaceuticals, Clinical Trials, R&D, Budget Management, Clinical Development, Biotechnology, Cross-functional Team..., Clinical Research, Program Management, Budgeting, PMP, Strategic Planning, Project Planning, Forecasting, MS Project, Risk Management, Product Life Cycle..., Team Building, Regulatory Submissions, Drug Development, Pharmaceutical Industry, Validation, Budgets, Biopharmaceuticals, Lifesciences, CRO, FDA, CTMS, Product Lifecycle..., Management, Product Development, EDC, Technology Transfer, Sop, Strategy, GMP, IND, GCP, 21 CFR Part 11, Computer System..., Clinical Monitoring, Drug Discovery, ICH-GCP, Clinical Operations, Clinical Data Management, GLP, Therapeutic Areas, Biomarkers, Life Sciences
Education
Rutgers, The State University of New Jersey - Rutgers Business School 2014 — 2016
Master of Business Administration (M.B.A.)
Rutgers University
Mini MBA, BioPharma Innovation Program
Project Management Institute
PMP, Project Management
Stevens Institute of Technology
Master of Science, Management - Project Management
Stevens Institute of Technology
Master of Science, Chemistry
Stevens Institute of Technology 1992 — 1996
Bachelor of Science, Chemical Biology
Regeneron Pharmaceuticals April 2012 - Present
Roche Pharmaceuticals July 2011 - April 2012
Roche Pharmaceuticals October 2007 - April 2012
Eisai Medical Research October 2004 - October 2007
J & J PRD, L.L.C July 2003 - February 2004
Pharmacia Corp May 2002 - June 2003
Lavipharm Corp. September 2000 - May 2002
Skills
Oncology, Pharmaceuticals, Clinical Trials, R&D, Budget Management, Clinical Development, Biotechnology, Cross-functional Team..., Clinical Research, Program Management, Budgeting, PMP, Strategic Planning, Project Planning, Forecasting, MS Project, Risk Management, Product Life Cycle..., Team Building, Regulatory Submissions, Drug Development, Pharmaceutical Industry, Validation, Budgets, Biopharmaceuticals, Lifesciences, CRO, FDA, CTMS, Product Lifecycle..., Management, Product Development, EDC, Technology Transfer, Sop, Strategy, GMP, IND, GCP, 21 CFR Part 11, Computer System..., Clinical Monitoring, Drug Discovery, ICH-GCP, Clinical Operations, Clinical Data Management, GLP, Therapeutic Areas, Biomarkers, Life Sciences
Education
Rutgers, The State University of New Jersey - Rutgers Business School 2014 — 2016
Master of Business Administration (M.B.A.)
Rutgers University
Mini MBA, BioPharma Innovation Program
Project Management Institute
PMP, Project Management
Stevens Institute of Technology
Master of Science, Management - Project Management
Stevens Institute of Technology
Master of Science, Chemistry
Stevens Institute of Technology 1992 — 1996
Bachelor of Science, Chemical Biology
Deb Baretz's Eisai Medical Research Experience 1998 - 2007
Job Senior Director at Harvard Clinical Research Institute
Industry Research
Experience
Harvard Clinical Research Institute November 2014 - Present
Harvard Clinical Research Institute March 2010 - October 2014
Harvard Clinical Research Institute October 2009 - February 2010
Harvard Clinical Research Institute September 2007 - September 2009
Eisai Medical Research 1998 - 2007
Skills
Clinical Data Management, Strategic Planning, EDC, Data Management, Clinical Development, GCP, CTMS, Oncology, FDA, Biotechnology, Regulatory Affairs, 21 CFR Part 11, Biostatistics, CDISC, CRO, Clinical Trials, ICH-GCP, Life Sciences, Team Leadership
Education
U. of Hawaii at Manoa 1977 — 1980
MPH, Biostatistics
University at Albany, SUNY 1971 — 1975
BA, Psychology
Fairleigh Dickinson University
MA, Psychology
Harvard Clinical Research Institute November 2014 - Present
Harvard Clinical Research Institute March 2010 - October 2014
Harvard Clinical Research Institute October 2009 - February 2010
Harvard Clinical Research Institute September 2007 - September 2009
Eisai Medical Research 1998 - 2007
Skills
Clinical Data Management, Strategic Planning, EDC, Data Management, Clinical Development, GCP, CTMS, Oncology, FDA, Biotechnology, Regulatory Affairs, 21 CFR Part 11, Biostatistics, CDISC, CRO, Clinical Trials, ICH-GCP, Life Sciences, Team Leadership
Education
U. of Hawaii at Manoa 1977 — 1980
MPH, Biostatistics
University at Albany, SUNY 1971 — 1975
BA, Psychology
Fairleigh Dickinson University
MA, Psychology
Jeffrey Liebman's Eisai Medical Research Experience November 2014 - Present
Job Senior Manager, Medical Writing at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research November 2014 - Present
Eisai Medical Research June 2011 - November 2014
Eisai Medical Research March 2006 - June 2011
Self-employed January 2005 - March 2006
Novartis 1997 - 2004
Ciba-Geigy Pharmaceuticals 1976 - 1997
Skills
Medical Writing, Oncology, Pharmaceutical Industry, Clinical Development, Clinical Trials, Therapeutic Areas, GCP, Drug Development, CRO, Regulatory Submissions, IND, CTMS
Education
University of California, Los Angeles
PhD, Physiological Psychology
Eisai Medical Research November 2014 - Present
Eisai Medical Research June 2011 - November 2014
Eisai Medical Research March 2006 - June 2011
Self-employed January 2005 - March 2006
Novartis 1997 - 2004
Ciba-Geigy Pharmaceuticals 1976 - 1997
Skills
Medical Writing, Oncology, Pharmaceutical Industry, Clinical Development, Clinical Trials, Therapeutic Areas, GCP, Drug Development, CRO, Regulatory Submissions, IND, CTMS
Education
University of California, Los Angeles
PhD, Physiological Psychology
Brijesh Ravi's Eisai Medical Research Experience February 2009 - August 2010
Job Principal Programmer at Regeneron Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals, Inc. April 2014 - Present
Regeneron Pharmaceuticals April 2013 - Present
ICON plc January 2012 - April 2013
i3 Statprobe August 2010 - January 2012
Eisai Medical Research February 2009 - August 2010
sanofi-aventis November 2005 - February 2009
Spectra February 2005 - November 2005
Clinstitute Inc. May 2001 - December 2004
Skills
SAS programming, SAS, CDISC, EDC
Education
University of Phoenix 2009 — 2013
DM/IST, Doctorate of Management in Organizational Leadership/Information Systems and Technology
Bharathiar University 1999 — 2001
M.Sc, Computer Science
Bharathiar University 1996 — 1999
B.Sc, Computer Science
Regeneron Pharmaceuticals, Inc. April 2014 - Present
Regeneron Pharmaceuticals April 2013 - Present
ICON plc January 2012 - April 2013
i3 Statprobe August 2010 - January 2012
Eisai Medical Research February 2009 - August 2010
sanofi-aventis November 2005 - February 2009
Spectra February 2005 - November 2005
Clinstitute Inc. May 2001 - December 2004
Skills
SAS programming, SAS, CDISC, EDC
Education
University of Phoenix 2009 — 2013
DM/IST, Doctorate of Management in Organizational Leadership/Information Systems and Technology
Bharathiar University 1999 — 2001
M.Sc, Computer Science
Bharathiar University 1996 — 1999
B.Sc, Computer Science
Lawrence Deetz's Eisai Medical Research Experience November 2001 - April 2008
Job Director, Clinical Operations at Lexicon Pharmaceuticals
Industry Pharmaceuticals
Experience
Lexicon Pharmaceuticals January 2014 - Present
Lexicon Pharmaceuticals July 2013 - January 2014
Celsion Corporation September 2011 - July 2013
ImClone Systems January 2009 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2009 - September 2011
Eisai Medical Research November 2001 - April 2008
Hoechst October 1988 - November 2001
Skills
Clinical Research, Oncology, Clinical Development, Pharmaceutical Industry, Sop, Cross-functional Team..., Clinical Trials, CTMS, R&D, Data Management, CRO, Quality Assurance, Clinical Data Management, FDA, Clinical Operations, Regulatory Affairs, Clinical Study Design, Medical Affairs
Education
Penn State University 1975 — 1979
PhD, Nutrition
Lexicon Pharmaceuticals January 2014 - Present
Lexicon Pharmaceuticals July 2013 - January 2014
Celsion Corporation September 2011 - July 2013
ImClone Systems January 2009 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2009 - September 2011
Eisai Medical Research November 2001 - April 2008
Hoechst October 1988 - November 2001
Skills
Clinical Research, Oncology, Clinical Development, Pharmaceutical Industry, Sop, Cross-functional Team..., Clinical Trials, CTMS, R&D, Data Management, CRO, Quality Assurance, Clinical Data Management, FDA, Clinical Operations, Regulatory Affairs, Clinical Study Design, Medical Affairs
Education
Penn State University 1975 — 1979
PhD, Nutrition
Lisa Schechet's Eisai Medical Research Experience February 2006 - October 2006
Job Sr. Study Manager at Ignyta
Industry Biotechnology
Experience
IGNYTA, Inc. February 2015 - Present
Halozyme Therapeutics, Inc. February 2011 - 2015
Orexigen Therapeutics August 2010 - February 2011
Halozyme Therapeutics, Inc. November 2006 - August 2010
Eisai Medical Research February 2006 - October 2006
Metropolitan Research Associates April 2004 - February 2006
New York Presbyterian Hospital October 2003 - April 2004
Skills
Clinical Trials, Clinical Development
Education
The Johns Hopkins University 2002 — 2003
BSN, Nursing
Gettysburg College 1999 — 2001
BA, Health and Exercise Science
IGNYTA, Inc. February 2015 - Present
Halozyme Therapeutics, Inc. February 2011 - 2015
Orexigen Therapeutics August 2010 - February 2011
Halozyme Therapeutics, Inc. November 2006 - August 2010
Eisai Medical Research February 2006 - October 2006
Metropolitan Research Associates April 2004 - February 2006
New York Presbyterian Hospital October 2003 - April 2004
Skills
Clinical Trials, Clinical Development
Education
The Johns Hopkins University 2002 — 2003
BSN, Nursing
Gettysburg College 1999 — 2001
BA, Health and Exercise Science
Antonio Laurenza's Eisai Medical Research Experience February 2008 - Present
Job Executive Director at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research February 2008 - Present
GlaxoSmithKline July 1990 - February 2008
US FDA December 1984 - July 1990
Skills
Psychiatry, Neurology, Clinical Development, Translational Medicine, Clinical Trials, Pharmaceutical Industry, Drug Development, Neuroscience
Education
Università degli Studi di Napoli 'Federico II' 1979 — 1984
MD
Università degli Studi di Napoli 'Federico II' 1974 — 1979
MD
Eisai Medical Research February 2008 - Present
GlaxoSmithKline July 1990 - February 2008
US FDA December 1984 - July 1990
Skills
Psychiatry, Neurology, Clinical Development, Translational Medicine, Clinical Trials, Pharmaceutical Industry, Drug Development, Neuroscience
Education
Università degli Studi di Napoli 'Federico II' 1979 — 1984
MD
Università degli Studi di Napoli 'Federico II' 1974 — 1979
MD
Sandeep Kottam's Eisai Medical Research Experience July 2009 - July 2010
Job Section Cochair Large Datasets at NESUG 2012
Industry Pharmaceuticals
Experience
NESUG 2012 January 2012 - Present
CDISC SDS 2011 - Present
Various Pharmaceutical Companies February 2002 - Present
ICON plc June 2011 - March 2013
NESUG 2011 September 2011 - September 2011
Ockham Development Group (an ASG Company) August 2010 - June 2011
Eisai Medical Research July 2009 - July 2010
Auxilium Pharmaceuticals 2008 - July 2009
Skills
CDISC, SAS, Biostatistics, EDC, Clinical Trials, SAS programming, SDTM, Clinical Data Management, Unix, CRO, GCP, Analysis, CRF design, Data Management, ICH-GCP, Clinical Development, Clinical Research, FDA, Statistical Programming, 21 CFR Part 11, Data Analysis, CTMS, Validation, SAS Programming, Oracle Clinical
Education
South Dakota State University
MASTERS, INDUSTRIAL MANAGEMENT, MINOR STATISTICS
St. Pauls school kurnool
NESUG 2012 January 2012 - Present
CDISC SDS 2011 - Present
Various Pharmaceutical Companies February 2002 - Present
ICON plc June 2011 - March 2013
NESUG 2011 September 2011 - September 2011
Ockham Development Group (an ASG Company) August 2010 - June 2011
Eisai Medical Research July 2009 - July 2010
Auxilium Pharmaceuticals 2008 - July 2009
Skills
CDISC, SAS, Biostatistics, EDC, Clinical Trials, SAS programming, SDTM, Clinical Data Management, Unix, CRO, GCP, Analysis, CRF design, Data Management, ICH-GCP, Clinical Development, Clinical Research, FDA, Statistical Programming, 21 CFR Part 11, Data Analysis, CTMS, Validation, SAS Programming, Oracle Clinical
Education
South Dakota State University
MASTERS, INDUSTRIAL MANAGEMENT, MINOR STATISTICS
St. Pauls school kurnool
Cassandra Murphy's Eisai Medical Research Experience November 2004 - May 2008
Job Associate Director Strategic Outsourcing
Industry Pharmaceuticals
Experience
Novartis November 2012 - Present
Hoffmann-La Roche May 2008 - February 2012
Eisai Medical Research November 2004 - May 2008
Schering-Plough 1990 - November 2004
Skills
Contract Negotiation, Process Improvement, Strategic Sourcing, Contract Management, Vendor Management, Pharmaceutical Industry, Management, Clinical Development, Clinical Trials, CRO, Budgets, Forecasting, Biotechnology, CTMS, Oncology, Outsourcing
Education
Mountain State University
Masters of Science, Strategic Leadership
William Paterson University of New Jersey
Bachelors Science, Accounting
Novartis November 2012 - Present
Hoffmann-La Roche May 2008 - February 2012
Eisai Medical Research November 2004 - May 2008
Schering-Plough 1990 - November 2004
Skills
Contract Negotiation, Process Improvement, Strategic Sourcing, Contract Management, Vendor Management, Pharmaceutical Industry, Management, Clinical Development, Clinical Trials, CRO, Budgets, Forecasting, Biotechnology, CTMS, Oncology, Outsourcing
Education
Mountain State University
Masters of Science, Strategic Leadership
William Paterson University of New Jersey
Bachelors Science, Accounting
Rachel Somsen's Eisai Medical Research Experience July 2007 - December 2008
Job Medical Device Auditor at TUV SUD America
Industry Medical Devices
Experience
TUV SUD America, Inc. March 2013 - Present
American Medical Systems May 2009 - October 2012
Eisai Medical Research July 2007 - December 2008
MGI Pharma July 2007 - December 2008
3M Drug Delivery Systems 1999 - 2007
3M June 1987 - December 1998
Skills
Validation, Quality System, FDA, Medical Devices, Supply Management, Auditing, Compliance, GLP, GMP, ISO 13485, Lifesciences, Pharmaceutical Industry, Quality Auditing, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Technical Writing
Education
University of Minnesota-Twin Cities 1983 — 1986
Master's Degree, Laboratory Medicine and Clinical Pathology, 3.4
Baldwin-Woodville
High School, College Preparatory
Northwestern College
Bachelor's Degree, Biology/Medical Technology, 3.3
TUV SUD America, Inc. March 2013 - Present
American Medical Systems May 2009 - October 2012
Eisai Medical Research July 2007 - December 2008
MGI Pharma July 2007 - December 2008
3M Drug Delivery Systems 1999 - 2007
3M June 1987 - December 1998
Skills
Validation, Quality System, FDA, Medical Devices, Supply Management, Auditing, Compliance, GLP, GMP, ISO 13485, Lifesciences, Pharmaceutical Industry, Quality Auditing, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Technical Writing
Education
University of Minnesota-Twin Cities 1983 — 1986
Master's Degree, Laboratory Medicine and Clinical Pathology, 3.4
Baldwin-Woodville
High School, College Preparatory
Northwestern College
Bachelor's Degree, Biology/Medical Technology, 3.3
Trupti Shastri's Eisai Medical Research Experience July 2007 - August 2010
Job Project Coordinator/Executive Assistant at Dr. Reddy's Laboratories
Industry Pharmaceuticals
Experience
Dr. Reddy's Laboratories August 2010 - Present
Eisai Medical Research July 2007 - August 2010
GAIN Capital March 2006 - June 2007
Morristown Memorial Hospital September 2003 - December 2006
HMHTTC Response Team Inc 1999 - 2003
Skills
Administrative..., Access, Human Resources, Time Management, Interviews, Purchasing, Travel Arrangements, Confidentiality, Account Reconciliation, Filing, Office Equipment, Expense Reports, Finance, Microsoft Word, Microsoft Excel, PowerPoint, Lotus Notes, Outlook, Concur, Project Management, Project Planning, Meeting Planning, Organizing Meetings, Project Coordination, Executive-level..., Detailed Reports, Data Analysis, Problem Solving, Process Improvements, Customer Service, Cross-functional Fluency
Education
William Paterson University of New Jersey 2001 — 2003
Bachelor’s Degree in Psychology, Elementary Education and Teaching
County College of Morris 1999 — 2000
Dr. Reddy's Laboratories August 2010 - Present
Eisai Medical Research July 2007 - August 2010
GAIN Capital March 2006 - June 2007
Morristown Memorial Hospital September 2003 - December 2006
HMHTTC Response Team Inc 1999 - 2003
Skills
Administrative..., Access, Human Resources, Time Management, Interviews, Purchasing, Travel Arrangements, Confidentiality, Account Reconciliation, Filing, Office Equipment, Expense Reports, Finance, Microsoft Word, Microsoft Excel, PowerPoint, Lotus Notes, Outlook, Concur, Project Management, Project Planning, Meeting Planning, Organizing Meetings, Project Coordination, Executive-level..., Detailed Reports, Data Analysis, Problem Solving, Process Improvements, Customer Service, Cross-functional Fluency
Education
William Paterson University of New Jersey 2001 — 2003
Bachelor’s Degree in Psychology, Elementary Education and Teaching
County College of Morris 1999 — 2000
Carrie Mazzrillo, BS, MBA's Eisai Medical Research Experience August 2007 - August 2008
Job Senior Submission Manager at Eisai Inc.
Industry Pharmaceuticals
Experience
Eisai Inc. June 2015 - Present
Eisai Inc. June 2010 - May 2015
Eisai Inc. August 2008 - May 2010
Eisai Medical Research August 2007 - August 2008
Eisai Medical Research Inc. June 2006 - July 2007
Eisai Medical Research Inc. February 2003 - June 2006
Eisai Inc. November 2001 - February 2003
Eisai May 2001 - October 2001
ARC of Bergen and Passaic April 2000 - February 2001
Center for the Disabled January 1994 - March 2000
Skills
Document Management, Microsoft Office, Business Process, Pharmaceuticals, Regulatory Submissions, Documentum, Regulatory Affairs, SOP, FDA, Validation, Documentation, Compliance, eCTD, Adobe Acrobat, Change Control, IND, Cross-functional Team..., Process Improvement, Word, Situational Leadership, Situational Self..., NDA, Global Dossier, Project Management, Emotional Intelligence, CRO, Sop, Drug Development, Pharmaceutical Industry, Quality Assurance, EDC, Clinical Development
Education
University of Phoenix 2005 — 2007
MBA, Business Administration
Excelsior College 2004 — 2005
BS, Psychology
Eisai Inc. June 2015 - Present
Eisai Inc. June 2010 - May 2015
Eisai Inc. August 2008 - May 2010
Eisai Medical Research August 2007 - August 2008
Eisai Medical Research Inc. June 2006 - July 2007
Eisai Medical Research Inc. February 2003 - June 2006
Eisai Inc. November 2001 - February 2003
Eisai May 2001 - October 2001
ARC of Bergen and Passaic April 2000 - February 2001
Center for the Disabled January 1994 - March 2000
Skills
Document Management, Microsoft Office, Business Process, Pharmaceuticals, Regulatory Submissions, Documentum, Regulatory Affairs, SOP, FDA, Validation, Documentation, Compliance, eCTD, Adobe Acrobat, Change Control, IND, Cross-functional Team..., Process Improvement, Word, Situational Leadership, Situational Self..., NDA, Global Dossier, Project Management, Emotional Intelligence, CRO, Sop, Drug Development, Pharmaceutical Industry, Quality Assurance, EDC, Clinical Development
Education
University of Phoenix 2005 — 2007
MBA, Business Administration
Excelsior College 2004 — 2005
BS, Psychology
Jill Greene's Eisai Medical Research Experience May 2006 - Present
Job Sr. Clinical Supplies Associate at Eisai Inc.
Industry Pharmaceuticals
Experience
Eisai Medical Research May 2006 - Present
Eisai Inc. May 2006 - Present
Aptuit March 2006 - May 2006
Almedica Services 2002 - 2006
Almedica Technology Group 1994 - 1999
Skills
Clinical Trials, CRO, Clinical Supplies, GMP, Clinical Development, CTMS, Data Management, 21 CFR Part 11, GLP, Pharmaceutical Industry, Sop, Biotechnology, FDA, GCP, SOP
Education
University of Richmond 1972 — 1976
BS, Psychology, Minor Biology
Eisai Medical Research May 2006 - Present
Eisai Inc. May 2006 - Present
Aptuit March 2006 - May 2006
Almedica Services 2002 - 2006
Almedica Technology Group 1994 - 1999
Skills
Clinical Trials, CRO, Clinical Supplies, GMP, Clinical Development, CTMS, Data Management, 21 CFR Part 11, GLP, Pharmaceutical Industry, Sop, Biotechnology, FDA, GCP, SOP
Education
University of Richmond 1972 — 1976
BS, Psychology, Minor Biology
John Roche's Eisai Medical Research Experience October 2008 - October 2010
Job Sr. Regulatory Medical Writer at Novartis
Industry Pharmaceuticals
Experience
Novartis April 2013 - Present
JPR Writing & Consulting, LLC March 2012 - April 2013
Celgene October 2010 - March 2012
Eisai Medical Research October 2008 - October 2010
ORION Clinical Services May 2008 - October 2008
Wyeth Pharmaceuticals October 2007 - May 2008
Bristol-Myers Squibb October 2005 - October 2007
Bristol-Myers Squibb October 2003 - October 2005
Skills
Medical Writing, Oncology, Clinical Development, Clinical Trial..., Regulatory Submissions, Clinical Research, Clinical Trials, Clinical Pharmacology, Hematology, Protocol Development, CRO, Immunology, Cancer, Clinical Monitoring, Cardiology, Rheumatoid Arthritis, IND, Biostatistics, Pharmacovigilance
Education
Penn State University 1998 — 2003
BS, Life Sciences
Novartis April 2013 - Present
JPR Writing & Consulting, LLC March 2012 - April 2013
Celgene October 2010 - March 2012
Eisai Medical Research October 2008 - October 2010
ORION Clinical Services May 2008 - October 2008
Wyeth Pharmaceuticals October 2007 - May 2008
Bristol-Myers Squibb October 2005 - October 2007
Bristol-Myers Squibb October 2003 - October 2005
Skills
Medical Writing, Oncology, Clinical Development, Clinical Trial..., Regulatory Submissions, Clinical Research, Clinical Trials, Clinical Pharmacology, Hematology, Protocol Development, CRO, Immunology, Cancer, Clinical Monitoring, Cardiology, Rheumatoid Arthritis, IND, Biostatistics, Pharmacovigilance
Education
Penn State University 1998 — 2003
BS, Life Sciences
Naiyer Azam's Eisai Medical Research Experience January 2007 - May 2011
Job Associate Director at Eisai Inc
Industry Pharmaceuticals
Experience
Eisai Inc June 2011 - Present
Eisai Medical Research January 2007 - May 2011
Neopharm, Inc. August 2005 - December 2006
University of Pennsylvania, Wistar Institute May 2003 - July 2005
Temple University School of Medicine, Fels Institute for Cancer Research 1996 - 2003
University of Toronto 1995 - 1996
CDRI, Lucknow 1986 - 1987
Skills
Oncology, Neuroscience, Strategic Planning, Business Development, Drug Development, Clinical Development, Medical Writing, Pharmaceutical Industry, Strategy, CTMS, Clinical Trials, Biotechnology, Commercialization, Lifesciences, Drug Discovery, Regulatory Affairs, Immunology, Market Access, CRO, Technology Transfer, Competitive Intelligence, Neurology, Pharmaceutics, Diabetes, Cross-functional...
Education
Fox School of Business, Temple University 2003 — 2005
MBA, Marketing
Indian Institute of Technology, Bombay 1989 — 1994
Doctor of Philosophy (PhD), Biosciences
Eisai Inc June 2011 - Present
Eisai Medical Research January 2007 - May 2011
Neopharm, Inc. August 2005 - December 2006
University of Pennsylvania, Wistar Institute May 2003 - July 2005
Temple University School of Medicine, Fels Institute for Cancer Research 1996 - 2003
University of Toronto 1995 - 1996
CDRI, Lucknow 1986 - 1987
Skills
Oncology, Neuroscience, Strategic Planning, Business Development, Drug Development, Clinical Development, Medical Writing, Pharmaceutical Industry, Strategy, CTMS, Clinical Trials, Biotechnology, Commercialization, Lifesciences, Drug Discovery, Regulatory Affairs, Immunology, Market Access, CRO, Technology Transfer, Competitive Intelligence, Neurology, Pharmaceutics, Diabetes, Cross-functional...
Education
Fox School of Business, Temple University 2003 — 2005
MBA, Marketing
Indian Institute of Technology, Bombay 1989 — 1994
Doctor of Philosophy (PhD), Biosciences
Laurel Donahue Marshall, Consulting's Eisai Medical Research Experience July 2009 - December 2010
Job Consultant, Clinical Operations at Ardelyx, Inc.
Industry Pharmaceuticals
Experience
Ardelyx, Inc. January 2011 - Present
Oracle Corporation January 2011 - February 2012
Phase Forward December 2006 - January 2011
Eisai Medical Research July 2009 - December 2010
Trine Pharmaceuticals October 2006 - February 2008
Wyeth Consumer Healthcare July 2005 - January 2007
BioPharma Development May 2003 - June 2004
Phaedrus Pharmaceuticals October 2002 - March 2003
Phase Forward January 2000 - August 2000
Ascent Pediatrics January 1994 - January 2000
Skills
CRO, EDC, Clinical Data Management, Clinical Trials, Data Management, Clinical Study Design, Oncology, Clinical Research, Phase I, Clinical Operations, Program Management, FDA
Education
Boston University School of Medicine 1988 — 1990
MPH
Clark University 1983 — 1987
B.A.
...
Ardelyx, Inc. January 2011 - Present
Oracle Corporation January 2011 - February 2012
Phase Forward December 2006 - January 2011
Eisai Medical Research July 2009 - December 2010
Trine Pharmaceuticals October 2006 - February 2008
Wyeth Consumer Healthcare July 2005 - January 2007
BioPharma Development May 2003 - June 2004
Phaedrus Pharmaceuticals October 2002 - March 2003
Phase Forward January 2000 - August 2000
Ascent Pediatrics January 1994 - January 2000
Skills
CRO, EDC, Clinical Data Management, Clinical Trials, Data Management, Clinical Study Design, Oncology, Clinical Research, Phase I, Clinical Operations, Program Management, FDA
Education
Boston University School of Medicine 1988 — 1990
MPH
Clark University 1983 — 1987
B.A.
...
Ndiritu Muriuki's Eisai Medical Research Experience August 2005 - December 2006
Job Enterprise Infrastructure Solution Architect
Industry Accounting
Experience
Ernst & Young March 2011 - Present
KPMG January 2009 - February 2011
Ernst & Young July 2007 - December 2008
NYK Shipping Line 2007 - 2007
Eisai Medical Research August 2005 - December 2006
M & M Mars 2003 - 2004
Skills
ITIL, IT Strategy, Enterprise Architecture, Data Center, Disaster Recovery, VMware, Solution Architecture, SDLC
Education
Stevens Institute of Technology
BE, Computer Engineering
Ernst & Young March 2011 - Present
KPMG January 2009 - February 2011
Ernst & Young July 2007 - December 2008
NYK Shipping Line 2007 - 2007
Eisai Medical Research August 2005 - December 2006
M & M Mars 2003 - 2004
Skills
ITIL, IT Strategy, Enterprise Architecture, Data Center, Disaster Recovery, VMware, Solution Architecture, SDLC
Education
Stevens Institute of Technology
BE, Computer Engineering
Franklin K. Johnson's Eisai Medical Research Experience November 2009 - July 2011
Job Sr. Director, Clinical Pharmacology at Amicus Therapeutics
Industry Pharmaceuticals
Experience
Amicus Therapeutics July 2011 - Present
Eisai Medical Research November 2009 - July 2011
Alpharma Pharmaceuticals June 2006 - May 2009
Johnson & Johnson PRDUS January 2005 - June 2006
Bristol-Myers Squibb October 2002 - January 2005
Reliant Pharmaceuticals January 2001 - August 2002
Knoll Pharmaceutical Company July 1991 - January 2001
Skills
Clinical Trials, Clinical Development, Oncology, Drug Development, CRO, Regulatory Affairs
Education
Monmouth College
B.A., Biology
University of Illinois at Urbana-Champaign
M.S., Biology
Amicus Therapeutics July 2011 - Present
Eisai Medical Research November 2009 - July 2011
Alpharma Pharmaceuticals June 2006 - May 2009
Johnson & Johnson PRDUS January 2005 - June 2006
Bristol-Myers Squibb October 2002 - January 2005
Reliant Pharmaceuticals January 2001 - August 2002
Knoll Pharmaceutical Company July 1991 - January 2001
Skills
Clinical Trials, Clinical Development, Oncology, Drug Development, CRO, Regulatory Affairs
Education
Monmouth College
B.A., Biology
University of Illinois at Urbana-Champaign
M.S., Biology
Shannon Goldrick's Eisai Medical Research Experience May 2009 - May 2010
Job Administrative Assistant
Industry Banking
Experience
Bridgewater Associates September 2013 - Present
Par Pharmaceutical April 2011 - August 2013
Pepsi Beverages Company June 2010 - April 2011
Eisai Medical Research May 2009 - May 2010
Mediaimagecoach.com 2006 - 2008
Skills
Financial Reporting, Forecasting, Variance Analysis, Hyperion Enterprise, JD Edwards, Financial Analysis, Accounting, Auditing, Financial Accounting, Internal Controls, Financial Modeling, Accounts Receivable, Internal Audit, Managerial Finance, Sarbanes-Oxley Act, Cost Accounting, Finance, Hyperion, Management, Microsoft Office
Education
Fordham University 2006 — 2010
BS, Applied Accounting and Finance
Tappan Zee High School
Bridgewater Associates September 2013 - Present
Par Pharmaceutical April 2011 - August 2013
Pepsi Beverages Company June 2010 - April 2011
Eisai Medical Research May 2009 - May 2010
Mediaimagecoach.com 2006 - 2008
Skills
Financial Reporting, Forecasting, Variance Analysis, Hyperion Enterprise, JD Edwards, Financial Analysis, Accounting, Auditing, Financial Accounting, Internal Controls, Financial Modeling, Accounts Receivable, Internal Audit, Managerial Finance, Sarbanes-Oxley Act, Cost Accounting, Finance, Hyperion, Management, Microsoft Office
Education
Fordham University 2006 — 2010
BS, Applied Accounting and Finance
Tappan Zee High School
Vinender Sodagum's Eisai Medical Research Experience April 2008 - December 2013
Job Associate Director, Data Operations at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research April 2008 - December 2013
Eisai Medical Research February 2005 - March 2008
Eisai Medical Research December 2003 - January 2005
Datanomics September 2003 - December 2003
CDI April 2002 - June 2003
UMDNJ July 1999 - November 2002
CGS Technology Associates February 1995 - April 2002
Computer Systems Development November 1994 - February 1995
Paragon Capital Corporation November 1993 - October 1994
Skills
Clinical Data Management, EDC, 21 CFR Part 11, SDTM, Data Standards, Clinical Trials, CDISC, Computer System..., Integration, Pharmaceutical Industry, Clinical Development, CTMS, CRO, Project Management, Cross-functional Team..., Data Management, Validation, FDA, Sop, GCP, Oncology
Education
New York Institute of Technology 1992 — 1994
MS, Computer Science
Eisai Medical Research April 2008 - December 2013
Eisai Medical Research February 2005 - March 2008
Eisai Medical Research December 2003 - January 2005
Datanomics September 2003 - December 2003
CDI April 2002 - June 2003
UMDNJ July 1999 - November 2002
CGS Technology Associates February 1995 - April 2002
Computer Systems Development November 1994 - February 1995
Paragon Capital Corporation November 1993 - October 1994
Skills
Clinical Data Management, EDC, 21 CFR Part 11, SDTM, Data Standards, Clinical Trials, CDISC, Computer System..., Integration, Pharmaceutical Industry, Clinical Development, CTMS, CRO, Project Management, Cross-functional Team..., Data Management, Validation, FDA, Sop, GCP, Oncology
Education
New York Institute of Technology 1992 — 1994
MS, Computer Science
Marci Pressner's Eisai Medical Research Experience 2007 - 2008
Job Sr. Admin Asst at Bayer HealthCare
Industry Pharmaceuticals
Experience
Bayer HealthCare November 2008 - July 2012
Eisai Medical Research 2007 - 2008
Empire International/CLS 2006 - 2007
Cambrex 2004 - 2005
Skills
Strategic Planning, Team Building, Coaching
Education
Fairleigh Dickinson University
Paralegal Certificate, General Paralegal
State University of New York @ Stony brook
Bachelor of Arts (BA), Sociology
Bayer HealthCare November 2008 - July 2012
Eisai Medical Research 2007 - 2008
Empire International/CLS 2006 - 2007
Cambrex 2004 - 2005
Skills
Strategic Planning, Team Building, Coaching
Education
Fairleigh Dickinson University
Paralegal Certificate, General Paralegal
State University of New York @ Stony brook
Bachelor of Arts (BA), Sociology
Harvey Altman's Eisai Medical Research Experience 2000 - 2003
Job President at Precept Consulting, LLC
Industry Pharmaceuticals
Experience
Precept Consulting, LLC May 2013 - Present
Upsher-Smith Laboratories July 2012 - March 2013
Mitsubishi Tanabe Pharma Development America, Inc. April 2010 - April 2012
Mitsubishi Tanabe Pharma Development America, Inc. September 2003 - March 2010
Eisai Medical Research 2000 - 2003
Quintiles CNS Therapeutics 1998 - 2000
Midwest Behavioral Services, LLC 1995 - 1998
Skills
R&D, Clinical Research, Clinical Development, Clinical Operations, Phases 1-3, Single site to large..., CNS disorders, Neuroscience, Neurology, Psychiatry, Clinical trial design,..., Alzheimer's disease, Parkinson's disease, Movement Disorders, Acute Stroke, Pain, Diabetes, Diabetic Neuropathy, ADHD, Alcoholism, Clinical Trials, Drug Development, Therapeutic Areas, Oncology, Pharmaceutics, GCP, Medical Affairs, Pain Management, CTMS
Education
New York University
Ph.D., Biology, Neuroscience
NewYork Institute of Technology
Bachelor of Science, Biology
Precept Consulting, LLC May 2013 - Present
Upsher-Smith Laboratories July 2012 - March 2013
Mitsubishi Tanabe Pharma Development America, Inc. April 2010 - April 2012
Mitsubishi Tanabe Pharma Development America, Inc. September 2003 - March 2010
Eisai Medical Research 2000 - 2003
Quintiles CNS Therapeutics 1998 - 2000
Midwest Behavioral Services, LLC 1995 - 1998
Skills
R&D, Clinical Research, Clinical Development, Clinical Operations, Phases 1-3, Single site to large..., CNS disorders, Neuroscience, Neurology, Psychiatry, Clinical trial design,..., Alzheimer's disease, Parkinson's disease, Movement Disorders, Acute Stroke, Pain, Diabetes, Diabetic Neuropathy, ADHD, Alcoholism, Clinical Trials, Drug Development, Therapeutic Areas, Oncology, Pharmaceutics, GCP, Medical Affairs, Pain Management, CTMS
Education
New York University
Ph.D., Biology, Neuroscience
NewYork Institute of Technology
Bachelor of Science, Biology
Mark T Bielawski, MD's Eisai Medical Research Experience June 2009 - June 2010
Job Drug Safety and Medical Writing Specialist
Industry Pharmaceuticals
Experience
Eisai August 2013 - June 2015
Eisai June 2012 - August 2013
Eisai June 2010 - June 2012
Eisai Medical Research June 2009 - June 2010
Freelancer April 2003 - June 2010
IVAX August 2005 - April 2006
Albert Einstein College of Medicine April 1999 - April 2005
Skills
Medical Writing, Adobe Acrobat, Documentum, Oncology Clinical..., Drug Development, Regulatory Affairs, Clinical Development, GCP, Regulatory Submissions, Microsoft Office, Oncology, Management, Clinical Trials, CTMS, Therapeutic Areas, CRO, Pharmacovigilance, Drug Safety, Pharmaceutical Industry, Biotechnology, Drug Discovery, EDC, IND, Infectious Diseases, Life Sciences, FDA, Clinical Research, Protocol, Pharmaceutics, SOP, Medicine
Education
Akademia Medyczna im. Karola Marcinkowskiego w Poznaniu
MD
Queens College
BA, Biology
Eisai August 2013 - June 2015
Eisai June 2012 - August 2013
Eisai June 2010 - June 2012
Eisai Medical Research June 2009 - June 2010
Freelancer April 2003 - June 2010
IVAX August 2005 - April 2006
Albert Einstein College of Medicine April 1999 - April 2005
Skills
Medical Writing, Adobe Acrobat, Documentum, Oncology Clinical..., Drug Development, Regulatory Affairs, Clinical Development, GCP, Regulatory Submissions, Microsoft Office, Oncology, Management, Clinical Trials, CTMS, Therapeutic Areas, CRO, Pharmacovigilance, Drug Safety, Pharmaceutical Industry, Biotechnology, Drug Discovery, EDC, IND, Infectious Diseases, Life Sciences, FDA, Clinical Research, Protocol, Pharmaceutics, SOP, Medicine
Education
Akademia Medyczna im. Karola Marcinkowskiego w Poznaniu
MD
Queens College
BA, Biology
Junaid Kazi's Eisai Medical Research Experience December 2009 - Present
Job Assoc. Director, Clinical Data Programming Oncology, Eisai Pharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Medical Research December 2009 - Present
Progenics Pharmaceuticals 2006 - 2009
Progenics Pharmaceuticals 2006 - 2009
Progenics Pharmaceuticals 2006 - 2009
Skills
Oncology, Clinical Data Management, Clinical Trials, EDC, Oracle Clinical, Data Management, Quality Assurance, Pharmaceutical Industry, CRO, Inform, SAS, 21 CFR Part 11, CDISC, Data Analysis, SDLC
Education
University of Pune 1995 — 1997
MS, Computers
Eisai Medical Research December 2009 - Present
Progenics Pharmaceuticals 2006 - 2009
Progenics Pharmaceuticals 2006 - 2009
Progenics Pharmaceuticals 2006 - 2009
Skills
Oncology, Clinical Data Management, Clinical Trials, EDC, Oracle Clinical, Data Management, Quality Assurance, Pharmaceutical Industry, CRO, Inform, SAS, 21 CFR Part 11, CDISC, Data Analysis, SDLC
Education
University of Pune 1995 — 1997
MS, Computers
Leonard Oppenheimer's Eisai Medical Research Experience October 2004 - January 2006
Job Senior Director at J&J
Industry Pharmaceuticals
Experience
J&J January 2006 - Present
Eisai Medical Research October 2004 - January 2006
Merck Research Laboratories July 1977 - September 2004
Temple University 1975 - 1977
Skills
Biostatistics, Data Management, Clinical Development, Clinical Trials, Drug Development, Biomarkers, Regulatory Submissions, Clinical Data Management, Therapeutic Areas, Statistics, Neuroscience, Clinical Study Design
Education
University of North Carolina at Chapel Hill 1968 — 1971
PhD, Biostatistics
University of North Carolina at Chapel Hill 1966 — 1968
MS, Mathematical Statistics
City University of New York City College 1962 — 1966
BS, Mathematics
J&J January 2006 - Present
Eisai Medical Research October 2004 - January 2006
Merck Research Laboratories July 1977 - September 2004
Temple University 1975 - 1977
Skills
Biostatistics, Data Management, Clinical Development, Clinical Trials, Drug Development, Biomarkers, Regulatory Submissions, Clinical Data Management, Therapeutic Areas, Statistics, Neuroscience, Clinical Study Design
Education
University of North Carolina at Chapel Hill 1968 — 1971
PhD, Biostatistics
University of North Carolina at Chapel Hill 1966 — 1968
MS, Mathematical Statistics
City University of New York City College 1962 — 1966
BS, Mathematics
Anu Patel's Eisai Medical Research Experience 2009 - 2009
Job Clinical Trial Leader at Novartis Pharmaceuticals Corporation
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals Corporation March 2012 - Present
Novartis Pharmaceutical Co 2011 - March 2012
Memorial Sloan-Kettering Cancer Center October 2009 - March 2011
Eisai Medical Research 2009 - 2009
Skills
Oncology, Clinical Development, Pharmaceutical Industry
Education
Fairleigh Dickinson University 2005 — 2007
MS, Life Science
Novartis Pharmaceuticals Corporation March 2012 - Present
Novartis Pharmaceutical Co 2011 - March 2012
Memorial Sloan-Kettering Cancer Center October 2009 - March 2011
Eisai Medical Research 2009 - 2009
Skills
Oncology, Clinical Development, Pharmaceutical Industry
Education
Fairleigh Dickinson University 2005 — 2007
MS, Life Science
Josie Yang's Eisai Medical Research Experience 2006 - 2008
Job Associate VP Regulatory Affairs at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
Eisai Medical Research 2006 - 2008
FDA/CDER 1995 - 2006
Skills
IND, Regulatory Submissions, NDA, Drug Development, Regulatory Affairs, Clinical Development
Education
Auburn University, School of Vet Medicine
PhD, Immunotoxicology, Clinical Pathology
National Taiwan University
DVM, Veterinary Medicine
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
Eisai Medical Research 2006 - 2008
FDA/CDER 1995 - 2006
Skills
IND, Regulatory Submissions, NDA, Drug Development, Regulatory Affairs, Clinical Development
Education
Auburn University, School of Vet Medicine
PhD, Immunotoxicology, Clinical Pathology
National Taiwan University
DVM, Veterinary Medicine
Larry Berlow's Eisai Medical Research Experience September 2005 - August 2008
Job Highly experienced consultant writer / editor available for medical / regulatory projects in NY / NJ or WFH.
Industry Pharmaceuticals
Experience
any company Consultant - Medical WriterSchering-Plough Research Institute / Merck Research InstituteSeptember 2009 - March 2011
Eisai Medical Research September 2005 - August 2008
Skills
Therapeutic Areas, Medical Writing, FDA, Oncology, Clinical Trials, Infectious Diseases, Pharmacovigilance, Protocol, Quality Assurance, Cardiology, Pharmaceutical Industry
Education
City University of New York
B.A., M.A.
any company Consultant - Medical WriterSchering-Plough Research Institute / Merck Research InstituteSeptember 2009 - March 2011
Eisai Medical Research September 2005 - August 2008
Skills
Therapeutic Areas, Medical Writing, FDA, Oncology, Clinical Trials, Infectious Diseases, Pharmacovigilance, Protocol, Quality Assurance, Cardiology, Pharmaceutical Industry
Education
City University of New York
B.A., M.A.
Mingyu Li's Eisai Medical Research Experience June 2007 - August 2007
Job Principal Statistician at Celgene
Industry Pharmaceuticals
Experience
Celgene January 2010 - Present
Forest Laboratories September 2009 - December 2009
sanofi-aventis October 2008 - August 2009
Eisai Medical Research June 2007 - August 2007
Education
Rutgers University-New Brunswick 2004 — 2009
PHD, STATISTICS
University of Science and Technology of China 2000 — 2004
BS, STATISTICS
Celgene January 2010 - Present
Forest Laboratories September 2009 - December 2009
sanofi-aventis October 2008 - August 2009
Eisai Medical Research June 2007 - August 2007
Education
Rutgers University-New Brunswick 2004 — 2009
PHD, STATISTICS
University of Science and Technology of China 2000 — 2004
BS, STATISTICS
Anna Battaglia's Eisai Medical Research Experience 2006 - 2009
Job Director Study Feasibility and Patient RecruitmentGlobal Operations
Industry Pharmaceuticals
Experience
Allergan March 2009 - Present
Eisai Medical Research 2006 - 2009
Novartis 2001 - 2006
i3 Research January 2000 - September 2001
Schering-Plough Research Institute 1993 - 2000
Berlex Biosciences 1986 - 1993
Sandoz 1984 - 1986
Skills
Commercialization, Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Biotechnology, CRO, Drug Development, FDA, Cardiology, Neurology, Account Management, Strategic Planning, Sop, Regulatory Submissions, Regulatory Affairs, Quality System, Clinical Operations, CTMS, Clinical Data Management, Clinical Research
Education
Fairleigh Dickinson University
MBA, International Business
Allergan March 2009 - Present
Eisai Medical Research 2006 - 2009
Novartis 2001 - 2006
i3 Research January 2000 - September 2001
Schering-Plough Research Institute 1993 - 2000
Berlex Biosciences 1986 - 1993
Sandoz 1984 - 1986
Skills
Commercialization, Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Biotechnology, CRO, Drug Development, FDA, Cardiology, Neurology, Account Management, Strategic Planning, Sop, Regulatory Submissions, Regulatory Affairs, Quality System, Clinical Operations, CTMS, Clinical Data Management, Clinical Research
Education
Fairleigh Dickinson University
MBA, International Business
Janine Matechak, MBA's Eisai Medical Research Experience June 2009 - Present
Job Associate Manager at Eisai
Industry Pharmaceuticals
Experience
Eisai June 2014 - Present
Eisai Medical Research June 2009 - Present
Eisai April 2006 - June 2009
South Hudson Medical Associates May 2002 - April 2006
Skills
CTMS, CRO, FDA, GCP, Clinical Site Monitoring, ICH-GCP, Clinical Development, EDC, Therapeutic Areas, Psychiatry, Drug Development, Clinical Monitoring, Clinical Research, Clinical Operations, Clinical Trials, Clinical Data Management, Regulatory Submissions, Medical Writing, Protocol
Education
Fairleigh Dickinson University 2008 — 2011
MBA, Pharmaceutical Management
Eisai June 2014 - Present
Eisai Medical Research June 2009 - Present
Eisai April 2006 - June 2009
South Hudson Medical Associates May 2002 - April 2006
Skills
CTMS, CRO, FDA, GCP, Clinical Site Monitoring, ICH-GCP, Clinical Development, EDC, Therapeutic Areas, Psychiatry, Drug Development, Clinical Monitoring, Clinical Research, Clinical Operations, Clinical Trials, Clinical Data Management, Regulatory Submissions, Medical Writing, Protocol
Education
Fairleigh Dickinson University 2008 — 2011
MBA, Pharmaceutical Management
Joyce Staszewski's Eisai Medical Research Experience February 2009 - April 2010
Job Study Manager at Execupharm Inc.
Industry Pharmaceuticals
Experience
Execupharm Inc. January 2011 - Present
Eisai Medical Research February 2009 - April 2010
Execupharm Inc. September 2007 - August 2008
Pfizer January 2005 - August 2007
Pfizer December 1999 - January 2005
Pfizer March 1996 - December 1999
Pfizer October 1992 - March 1996
Skills
Clinical Development, Clinical Trials, GCP, CRO, EDC, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Sop, Therapeutic Areas, Regulatory Affairs, Drug Development, Medical Writing
Education
Temple University School of Pharmacy 2002 — 2002
Certification in Quality Assurance/Regulatory Affairs
Marymount Manhattan College 1984 — 1991
BS, Business Management/Marketing
Execupharm Inc. January 2011 - Present
Eisai Medical Research February 2009 - April 2010
Execupharm Inc. September 2007 - August 2008
Pfizer January 2005 - August 2007
Pfizer December 1999 - January 2005
Pfizer March 1996 - December 1999
Pfizer October 1992 - March 1996
Skills
Clinical Development, Clinical Trials, GCP, CRO, EDC, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Sop, Therapeutic Areas, Regulatory Affairs, Drug Development, Medical Writing
Education
Temple University School of Pharmacy 2002 — 2002
Certification in Quality Assurance/Regulatory Affairs
Marymount Manhattan College 1984 — 1991
BS, Business Management/Marketing
Dorita Stewart's Eisai Medical Research Experience May 2005 - September 2005
Job Project Data Manager Professional
Industry Biotechnology
Experience
Eisai 2012 - 2015
Progenics Pharmaceuticals July 2009 - September 2011
Progenics Pharmaceuticals July 2006 - July 2009
MannKind Corporation January 2006 - June 2006
Eisai Medical Research May 2005 - September 2005
Pfizer December 2000 - March 2004
Skills
ClinTrial, Medidata Rave,, Business Objects XI..., Phase Forward EDC..., InForm Central Coding, Oracle Clinical, Medical Dictionaries:..., InDesign CS4 6.0, Adobe..., Oracle SQL, Clinical Trials, Dictionaries, InDesign, Medicine, Medical Coding, Inform, Medidata, Data Management, Software Documentation, 21 CFR Part 11, Sop, Oncology, Pharmaceutical Industry, MedDRA, Clinical Data Management, FDA, EDC, CTMS, GCP, Quality Control, Therapeutic Areas, CDISC, Document Management, CRF design, Protocol, CRO, ICH-GCP, Clinical Research, Clinical Development, Clinical Monitoring, Pharmacovigilance, SOP
Education
Columbia, University, New York, NY
Post Bacalaureate Certificate, Computer Technology and Applications (CTA) Database Administration, Design & Developement (DADD)
Hunter College
Bachelor of Arts, Human Movement/ Pre-Physical therapy
State University of New York Health Science Center at Brooklyn
Post Baccalaureate Certificate, Medical Records Administration
Eisai 2012 - 2015
Progenics Pharmaceuticals July 2009 - September 2011
Progenics Pharmaceuticals July 2006 - July 2009
MannKind Corporation January 2006 - June 2006
Eisai Medical Research May 2005 - September 2005
Pfizer December 2000 - March 2004
Skills
ClinTrial, Medidata Rave,, Business Objects XI..., Phase Forward EDC..., InForm Central Coding, Oracle Clinical, Medical Dictionaries:..., InDesign CS4 6.0, Adobe..., Oracle SQL, Clinical Trials, Dictionaries, InDesign, Medicine, Medical Coding, Inform, Medidata, Data Management, Software Documentation, 21 CFR Part 11, Sop, Oncology, Pharmaceutical Industry, MedDRA, Clinical Data Management, FDA, EDC, CTMS, GCP, Quality Control, Therapeutic Areas, CDISC, Document Management, CRF design, Protocol, CRO, ICH-GCP, Clinical Research, Clinical Development, Clinical Monitoring, Pharmacovigilance, SOP
Education
Columbia, University, New York, NY
Post Bacalaureate Certificate, Computer Technology and Applications (CTA) Database Administration, Design & Developement (DADD)
Hunter College
Bachelor of Arts, Human Movement/ Pre-Physical therapy
State University of New York Health Science Center at Brooklyn
Post Baccalaureate Certificate, Medical Records Administration
Danielle Wells's Eisai Medical Research Experience 2005 - 2005
Job Process Development Engineer I at Regeneron Pharmaceuticals
Industry Biotechnology
Experience
Regeneron Pharmaceuticals, Inc June 2007 - Present
Lehigh University January 2007 - May 2007
Lehigh University August 2006 - May 2007
Eisai Medical Research 2005 - 2005
Education
Lehigh University 2003 — 2007
B.S., BioEngineering
Regeneron Pharmaceuticals, Inc June 2007 - Present
Lehigh University January 2007 - May 2007
Lehigh University August 2006 - May 2007
Eisai Medical Research 2005 - 2005
Education
Lehigh University 2003 — 2007
B.S., BioEngineering
Lisa Miglietta's Eisai Medical Research Experience 2005 - 2006
Job Clinical Research Associate, Clinical Trial Management
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals 2008 - 2012
Hoffman- LaRoche Inc. 2006 - 2007
Eisai Medical Research 2005 - 2006
Daiichi Medical Research Inc 2001 - 2005
Skills
Clinical Monitoring, Training, Vendor Management, Budget, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Photoshop, English, Teaching, Budgets
Education
New York University 1978 — 1980
Master's degree, Microbiology/immunology
Pace University - Dyson School of Arts and Science 1972 — 1976
Bachelor's degree (BS), Biology/Biological Sciences, General
Regeneron Pharmaceuticals 2008 - 2012
Hoffman- LaRoche Inc. 2006 - 2007
Eisai Medical Research 2005 - 2006
Daiichi Medical Research Inc 2001 - 2005
Skills
Clinical Monitoring, Training, Vendor Management, Budget, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Photoshop, English, Teaching, Budgets
Education
New York University 1978 — 1980
Master's degree, Microbiology/immunology
Pace University - Dyson School of Arts and Science 1972 — 1976
Bachelor's degree (BS), Biology/Biological Sciences, General
Haihong Zhu's Eisai Medical Research Experience May 2013 - Present
Job Statistician at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research May 2013 - Present
Novartis May 2012 - May 2013
Eisai September 2008 - May 2012
Eisai Medical Research 2008 - 2011
Eisai Medical Research 2008 - 2011
Skills
Clinical Trials, SAS, Biostatistics, Clinical Development, Oncology, Data Management, Clinical Study Design, CRO, Drug Development, Survival Analysis, Pharmaceutical Industry, CTMS, 21 CFR Part 11, Clinical Data Management, Protocol, SAS programming, Regulatory Submissions, Biotechnology, Validation, CDISC, GCP, Statistics, EDC, FDA, Logistic Regression, Statistical Modeling, Statistical Programming, SDTM, Medical Writing, Pharmacovigilance, Clinical Research, Epidemiology, Therapeutic Areas, CRF design, Predictive Modeling, R, Predictive Analytics, Bayesian statistics, S-Plus, Data Mining, Biomarkers
Education
University of Minnesota-Twin Cities
Doctor of Philosophy (PhD), Statistics
Eisai Medical Research May 2013 - Present
Novartis May 2012 - May 2013
Eisai September 2008 - May 2012
Eisai Medical Research 2008 - 2011
Eisai Medical Research 2008 - 2011
Skills
Clinical Trials, SAS, Biostatistics, Clinical Development, Oncology, Data Management, Clinical Study Design, CRO, Drug Development, Survival Analysis, Pharmaceutical Industry, CTMS, 21 CFR Part 11, Clinical Data Management, Protocol, SAS programming, Regulatory Submissions, Biotechnology, Validation, CDISC, GCP, Statistics, EDC, FDA, Logistic Regression, Statistical Modeling, Statistical Programming, SDTM, Medical Writing, Pharmacovigilance, Clinical Research, Epidemiology, Therapeutic Areas, CRF design, Predictive Modeling, R, Predictive Analytics, Bayesian statistics, S-Plus, Data Mining, Biomarkers
Education
University of Minnesota-Twin Cities
Doctor of Philosophy (PhD), Statistics
Adam Finkelstein's Eisai Medical Research Experience May 2008 - November 2008
Job Associate Manager, Clinical Contracts (Consultant) at Celgene
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals 2012 - Present
Celgene 2010 - Present
Dainippon Sumitomo Pharma 2008 - 2010
Sepracor 2008 - 2010
Eisai Medical Research May 2008 - November 2008
Schering-Plough Research Institute 2007 - 2008
Skills
Clinical Trials, Contract Negotiation, Contract Management, Clinical, Vendor Management, Clinical Research, Pharmaceutical Industry, GCP, Oncology, Biotechnology, FDA, Clinical Development, Sop, Quality Assurance, CRO, 21 CFR Part 11, CTMS, Drug Development, IND, Therapeutic Areas, EDC, Regulatory Submissions, Clinical Data Management, Regulatory Affairs, Lifesciences, Pharmacovigilance, Medical Writing, ICH-GCP, Biopharmaceuticals, Vaccines, GMP, Computer System..., SOP, Life Sciences
Education
Rutgers, The State University of New Jersey-New Brunswick
BS, Biological Sciences
Regeneron Pharmaceuticals 2012 - Present
Celgene 2010 - Present
Dainippon Sumitomo Pharma 2008 - 2010
Sepracor 2008 - 2010
Eisai Medical Research May 2008 - November 2008
Schering-Plough Research Institute 2007 - 2008
Skills
Clinical Trials, Contract Negotiation, Contract Management, Clinical, Vendor Management, Clinical Research, Pharmaceutical Industry, GCP, Oncology, Biotechnology, FDA, Clinical Development, Sop, Quality Assurance, CRO, 21 CFR Part 11, CTMS, Drug Development, IND, Therapeutic Areas, EDC, Regulatory Submissions, Clinical Data Management, Regulatory Affairs, Lifesciences, Pharmacovigilance, Medical Writing, ICH-GCP, Biopharmaceuticals, Vaccines, GMP, Computer System..., SOP, Life Sciences
Education
Rutgers, The State University of New Jersey-New Brunswick
BS, Biological Sciences
Michele Giliberti's Eisai Medical Research Experience January 2008 - July 2009
Job Senior Director, Clinical Research & Development at TherapeuticsMD
Industry Pharmaceuticals
Experience
TherapeuticsMD July 2014 - Present
Shionogi Inc. March 2014 - July 2014
Shionogi Inc. June 2012 - March 2014
Shionogi-USA April 2010 - June 2012
Novartis July 2009 - March 2010
Eisai Medical Research January 2008 - July 2009
Schering-Plough Research Institute May 1999 - January 2008
Skills
CTMS, Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, Clinical Operations, Neurology, Regulatory Submissions, Medical Affairs
Education
Rutgers, The State University of New Jersey-New Brunswick 1996 — 1998
Bachelor of Arts, Biological Sciences, Spanish
University of Arizona 1994 — 1996
TherapeuticsMD July 2014 - Present
Shionogi Inc. March 2014 - July 2014
Shionogi Inc. June 2012 - March 2014
Shionogi-USA April 2010 - June 2012
Novartis July 2009 - March 2010
Eisai Medical Research January 2008 - July 2009
Schering-Plough Research Institute May 1999 - January 2008
Skills
CTMS, Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, Clinical Operations, Neurology, Regulatory Submissions, Medical Affairs
Education
Rutgers, The State University of New Jersey-New Brunswick 1996 — 1998
Bachelor of Arts, Biological Sciences, Spanish
University of Arizona 1994 — 1996
Robert Shumaker's Eisai Medical Research Experience 2008 - Present
Job Senior Director, Clinical Pharmacology, Oncology at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research 2008 - Present
Sandoz 2006 - 2008
Ivax 2004 - 2006
Alpharma 1995 - 2004
Wallace Laboratories 1988 - 1995
Merrell Dow Research Institute 1980 - 1988
Warner Lambert Parke Davis 1977 - 1980
Skills
Oncology, Pharmaceutical Industry, Pharmacokinetics, Clinical Development, Clinical Trials, Clinical Pharmacology, Biotechnology, Drug Metabolism, CRO, Drug Development
Education
University of Wisconsin-Madison 1975 — 1977
PhD, Pathology and Veterinary Science
University of Wisconsin-Madison 1971 — 1975
MSc, Pathology
The Ohio State University 1967 — 1971
BSc, Microbiology
Eisai Medical Research 2008 - Present
Sandoz 2006 - 2008
Ivax 2004 - 2006
Alpharma 1995 - 2004
Wallace Laboratories 1988 - 1995
Merrell Dow Research Institute 1980 - 1988
Warner Lambert Parke Davis 1977 - 1980
Skills
Oncology, Pharmaceutical Industry, Pharmacokinetics, Clinical Development, Clinical Trials, Clinical Pharmacology, Biotechnology, Drug Metabolism, CRO, Drug Development
Education
University of Wisconsin-Madison 1975 — 1977
PhD, Pathology and Veterinary Science
University of Wisconsin-Madison 1971 — 1975
MSc, Pathology
The Ohio State University 1967 — 1971
BSc, Microbiology
Michael Everson's Eisai Medical Research Experience January 2008 - December 2012
Job Associate Director Clinical Research at Eisai Pharmaceuticals (NOT Clin. Ops.)
Industry Pharmaceuticals
Experience
Eisai Pharmaceuticals December 2012 - Present
Eisai Medical Research January 2008 - December 2012
Capstone Clinicl Trials January 2001 - November 2006
UAB Hospital 1994 - 1999
Skills
Clinical Development, Medical Writing, Clinical Trials, Infectious Diseases, Neurology, Pharmaceuticals, Clinical Research, Therapeutic areas, Life Sciences, Rheumatology, Cardiology, Clinical, Strategic Planning, R&D, Research, Clinical Trial..., Corporate Development, Global Health, Neglected Diseases, Public-private..., Pharmaceutical Industry, Therapeutic Areas, Lifesciences, Drug Development, CTMS, Biostatistics, Public/private..., Protocol, CRO, Immunology, Clinical Data Management, GCP, IND, EDC, Medical Affairs, Regulatory Submissions, Pharmacovigilance, Clinical Operations, Regulatory Affairs, Vaccines, ICH-GCP, Clinical Monitoring, Translational Medicine, Biomarkers, Drug Discovery, Biopharmaceuticals, 21 CFR Part 11, Biotechnology, FDA, Sop
Education
University of Alabama at Birmingham 1981 — 1986
PhD, Molecular Cell Biology, Immunology
Louisiana State University 1977 — 1980
BS, Microbiology
Eisai Pharmaceuticals December 2012 - Present
Eisai Medical Research January 2008 - December 2012
Capstone Clinicl Trials January 2001 - November 2006
UAB Hospital 1994 - 1999
Skills
Clinical Development, Medical Writing, Clinical Trials, Infectious Diseases, Neurology, Pharmaceuticals, Clinical Research, Therapeutic areas, Life Sciences, Rheumatology, Cardiology, Clinical, Strategic Planning, R&D, Research, Clinical Trial..., Corporate Development, Global Health, Neglected Diseases, Public-private..., Pharmaceutical Industry, Therapeutic Areas, Lifesciences, Drug Development, CTMS, Biostatistics, Public/private..., Protocol, CRO, Immunology, Clinical Data Management, GCP, IND, EDC, Medical Affairs, Regulatory Submissions, Pharmacovigilance, Clinical Operations, Regulatory Affairs, Vaccines, ICH-GCP, Clinical Monitoring, Translational Medicine, Biomarkers, Drug Discovery, Biopharmaceuticals, 21 CFR Part 11, Biotechnology, FDA, Sop
Education
University of Alabama at Birmingham 1981 — 1986
PhD, Molecular Cell Biology, Immunology
Louisiana State University 1977 — 1980
BS, Microbiology
Corrie Lewis's Eisai Medical Research Experience May 2005 - June 2009
Job Sr PM, CTMS Implementation at Medidata Solutions
Industry Pharmaceuticals
Experience
Medidata Solutions November 2014 - Present
Eisai April 2012 - Present
Eisai June 2009 - April 2011
Eisai Medical Research May 2005 - June 2009
Eisai Medical Research July 2004 - May 2005
Eisai Medical Research March 2004 - July 2004
Eisai Medical Research April 2003 - March 2004
EISAI INC October 2000 - April 2003
GENERAL CHEMICAL CORPORATION June 1998 - October 2000
General Chemical Corporation February 1998 - June 1998
Skills
Budgeting, Forecasting, Process Improvement, Lotus Notes, Visio, Financial Reporting, Budgets, PeopleSoft, Analysis, Cross-functional Team..., Microsoft Excel, Clinical Trials, Strategy, Project Planning, CRO, Clinical Development, Auditing, CTMS, SDLC, Pharmaceutical Industry, Management, Accounts Payable, Outlook, Payroll, Business Intelligence, EDC, Oncology
Education
Fairleigh Dickinson University 1993 — 1997
Bachelor of Science (BS), Accounting
Fairleigh Dickinson University 1993 — 1997
Bachelor of Science, Accounting
MHSS 1989 — 1993
Medidata Solutions November 2014 - Present
Eisai April 2012 - Present
Eisai June 2009 - April 2011
Eisai Medical Research May 2005 - June 2009
Eisai Medical Research July 2004 - May 2005
Eisai Medical Research March 2004 - July 2004
Eisai Medical Research April 2003 - March 2004
EISAI INC October 2000 - April 2003
GENERAL CHEMICAL CORPORATION June 1998 - October 2000
General Chemical Corporation February 1998 - June 1998
Skills
Budgeting, Forecasting, Process Improvement, Lotus Notes, Visio, Financial Reporting, Budgets, PeopleSoft, Analysis, Cross-functional Team..., Microsoft Excel, Clinical Trials, Strategy, Project Planning, CRO, Clinical Development, Auditing, CTMS, SDLC, Pharmaceutical Industry, Management, Accounts Payable, Outlook, Payroll, Business Intelligence, EDC, Oncology
Education
Fairleigh Dickinson University 1993 — 1997
Bachelor of Science (BS), Accounting
Fairleigh Dickinson University 1993 — 1997
Bachelor of Science, Accounting
MHSS 1989 — 1993
Jinnell Brown's Eisai Medical Research Experience August 2007 - January 2009
Job Contracts Manager at Bayer Healthcare
Industry Pharmaceuticals
Experience
Bayer HealthCare November 2012 - Present
Memorial Sloan-Kettering Cancer Center September 2011 - October 2012
Merck Sharp & Dohme February 2009 - May 2011
Eisai Medical Research August 2007 - January 2009
NYU Medical Center January 2006 - January 2007
Skills
Vendor Management, Financial Analysis, Process Improvement, Compliance, Contract Negotiation, Contract Management, Data Management, Budgeting, Forecasting, Strategic Planning, Clinical Trials, Pharmaceuticals, Financial Management, Budgets, Pharmaceutical Industry, Healthcare, Healthcare Management, Negotiation, Change Management, Project Management, GCP, FDA, Finance, Cross-functional Team..., CRO, CTMS, Clinical Data Management, Oncology, Biotechnology, EDC, Clinical Development
Education
University of Phoenix 2009 — 2011
Master Healthcare Administration
City University of New York-John Jay College of Criminal Justice 1997 — 2001
BS, Computer Information Systems
Bayer HealthCare November 2012 - Present
Memorial Sloan-Kettering Cancer Center September 2011 - October 2012
Merck Sharp & Dohme February 2009 - May 2011
Eisai Medical Research August 2007 - January 2009
NYU Medical Center January 2006 - January 2007
Skills
Vendor Management, Financial Analysis, Process Improvement, Compliance, Contract Negotiation, Contract Management, Data Management, Budgeting, Forecasting, Strategic Planning, Clinical Trials, Pharmaceuticals, Financial Management, Budgets, Pharmaceutical Industry, Healthcare, Healthcare Management, Negotiation, Change Management, Project Management, GCP, FDA, Finance, Cross-functional Team..., CRO, CTMS, Clinical Data Management, Oncology, Biotechnology, EDC, Clinical Development
Education
University of Phoenix 2009 — 2011
Master Healthcare Administration
City University of New York-John Jay College of Criminal Justice 1997 — 2001
BS, Computer Information Systems
Karl Coppage's Eisai Medical Research Experience April 2011 - Present
Job Diabetes Care Specialist at Novo Nordisk A/S
Industry Pharmaceuticals
Experience
Eisai Medical Research April 2011 - Present
Novo Nordisk A/S April 2011 - Present
Skills
Medical Devices, Pharmaceutical Sales, Pharmaceutical Industry, Event Planning, Cardiology, Endocrinology, Gastroenterology, Neurology, Urology, Rheumatology, Diabetes, Hospital Sales, Sales Operations
Education
Eastern Michigan University 1995 — 2000
Eisai Medical Research April 2011 - Present
Novo Nordisk A/S April 2011 - Present
Skills
Medical Devices, Pharmaceutical Sales, Pharmaceutical Industry, Event Planning, Cardiology, Endocrinology, Gastroenterology, Neurology, Urology, Rheumatology, Diabetes, Hospital Sales, Sales Operations
Education
Eastern Michigan University 1995 — 2000
Charles Callaghan's Eisai Medical Research Experience November 2004 - February 2011
Job Pharmaceutical Professional
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals; +30,000 employees November 2012 - Present
Eisai Medical Research November 2004 - February 2011
Eisai Medical Research September 1999 - November 2004
Skills
Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, Drug Development, GMP, Oncology
Education
University of North Carolina at Wilmington 1986 — 1989
BS, Biology
Takeda Pharmaceuticals; +30,000 employees November 2012 - Present
Eisai Medical Research November 2004 - February 2011
Eisai Medical Research September 1999 - November 2004
Skills
Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, Drug Development, GMP, Oncology
Education
University of North Carolina at Wilmington 1986 — 1989
BS, Biology
Maria Coppa-Meyers's Eisai Medical Research Experience 2011 - 2011
Job Clinical Operations Manager at Eisai
Industry Pharmaceuticals
Experience
Eisai December 2013 - Present
Arbonne International 2010 - 2014
PPD September 2011 - December 2012
Eisai Medical Research 2011 - 2011
Novartis 2003 - 2010
Education
Temple University 2006 — 2011
MS, Regulatory Affairs and Quality Assurance
The Catholic University of America 1989 — 1993
BS, Biology
Eisai December 2013 - Present
Arbonne International 2010 - 2014
PPD September 2011 - December 2012
Eisai Medical Research 2011 - 2011
Novartis 2003 - 2010
Education
Temple University 2006 — 2011
MS, Regulatory Affairs and Quality Assurance
The Catholic University of America 1989 — 1993
BS, Biology
Huachun Chen's Eisai Medical Research Experience September 2002 - Present
Job Senior Director of Clinical Pharmacology at Eisai Medical Research
Industry Pharmaceuticals
Experience
Eisai Medical Research September 2002 - Present
Education
The University of Georgia
Eisai Medical Research September 2002 - Present
Education
The University of Georgia
Jamila Clauzel's Eisai Medical Research Experience May 2002 - July 2007
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Execupharm 2007 - 2013
Eisai Medical Research May 2002 - July 2007
Education
New York University 1995 — 1999
Bachelor of Arts (B.A.), Pre-Medicine/Pre-Medical Studies
Execupharm 2007 - 2013
Eisai Medical Research May 2002 - July 2007
Education
New York University 1995 — 1999
Bachelor of Arts (B.A.), Pre-Medicine/Pre-Medical Studies
Gail Zimetbaum's Eisai Medical Research Experience January 2004 - December 2006
Job Looking for a new opportunity
Industry Pharmaceuticals
Experience
CROfessionals, Inc. September 2013 - March 2014
ICON Clinical Research January 2007 - March 2009
Eisai Medical Research January 2004 - December 2006
Ortho Biotech December 2001 - December 2003
Skills
Clinical Monitoring, ICH-GCP, EDC, CTMS, GCP, CRO, Clinical Trials, Therapeutic Areas, Oracle Clinical, Clinical Data Management, Patient Recruitment, CRF design, Clinical Development, Regulatory Submissions, Inform, Clinical Operations, Therapeutic Area, Rheumatoid Arthritis, Oncology, Trial Management
Education
Rutgars University 1984 — 1986
B.A, Zoology
St. Barnabas Medical Center 1979 — 1980
Certificate, Comparative and Laboratory Animal Medicine, 3.0
University of California, Berkeley 1974 — 1976
none, Marine Biology
CROfessionals, Inc. September 2013 - March 2014
ICON Clinical Research January 2007 - March 2009
Eisai Medical Research January 2004 - December 2006
Ortho Biotech December 2001 - December 2003
Skills
Clinical Monitoring, ICH-GCP, EDC, CTMS, GCP, CRO, Clinical Trials, Therapeutic Areas, Oracle Clinical, Clinical Data Management, Patient Recruitment, CRF design, Clinical Development, Regulatory Submissions, Inform, Clinical Operations, Therapeutic Area, Rheumatoid Arthritis, Oncology, Trial Management
Education
Rutgars University 1984 — 1986
B.A, Zoology
St. Barnabas Medical Center 1979 — 1980
Certificate, Comparative and Laboratory Animal Medicine, 3.0
University of California, Berkeley 1974 — 1976
none, Marine Biology
Peter Consalazio's Eisai Medical Research Experience March 2005 - Present
Job Oncology sales at Eisai Biopharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Medical Research March 2005 - Present
Elan Pharmaceuticals August 2001 - March 2005
GlaxoSmithKline April 1993 - August 2001
Skills
Oncology, Pharmaceutical Sales, Neurology, Pharmaceutical Industry, Hospitals, Hospital Sales, Gastroenterology, Sales Operations, Pain Management, Biotechnology, Rheumatology, Diabetes, Cardiology, Endocrinology, Sales Effectiveness, Managed Care
Education
Dowling College 1986 — 1990
Bachelor's degree, Marketing/Marketing Management, General
Eisai Medical Research March 2005 - Present
Elan Pharmaceuticals August 2001 - March 2005
GlaxoSmithKline April 1993 - August 2001
Skills
Oncology, Pharmaceutical Sales, Neurology, Pharmaceutical Industry, Hospitals, Hospital Sales, Gastroenterology, Sales Operations, Pain Management, Biotechnology, Rheumatology, Diabetes, Cardiology, Endocrinology, Sales Effectiveness, Managed Care
Education
Dowling College 1986 — 1990
Bachelor's degree, Marketing/Marketing Management, General