PAREXEL Consulting
Industry: Company
DescriptionFounded: 1982 Parent organization: PAREXEL
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PAREXEL Consulting Employees
Employee
Years
Job
Industry
Fahid Naseer Fahid Naseer's PAREXEL Consulting Experience April 2013 - June 2015
Job Project Specialist: Global Medicines Development & Affairs at Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Vertex Pharmaceuticals June 2015 - August 2015
PAREXEL Consulting April 2013 - June 2015
PAREXEL July 2012 - April 2013
Brigham and Women's Hospital May 2010 - August 2010
University of Health Sciences Lahore May 2009 - August 2009
Education
University of Massachusetts Boston 2007 — 2012
B.S., Biochemistry and Molecular Biology, Economics with Honors
Harvard University 2011 — 2012
Organic Chemistry with Honors
Vertex Pharmaceuticals June 2015 - August 2015
PAREXEL Consulting April 2013 - June 2015
PAREXEL July 2012 - April 2013
Brigham and Women's Hospital May 2010 - August 2010
University of Health Sciences Lahore May 2009 - August 2009
Education
University of Massachusetts Boston 2007 — 2012
B.S., Biochemistry and Molecular Biology, Economics with Honors
Harvard University 2011 — 2012
Organic Chemistry with Honors
Vivian Bringslimark Vivian Bringslimark's PAREXEL Consulting Experience April 2002 - July 2008
Job President and Owner of HPIS Consulting, Inc.
Industry Pharmaceuticals
Experience
HPIS Consulting, Inc August 2008 - Present
SE FL Chapter of ATD May 2014 - Present
GMP TEA, Inc. October 2007 - Present
GMP TEA, Inc. January 2012 - June 2014
GMP TEA, Inc. February 2011 - December 2013
GMP TEA, Inc. January 2012 - November 2013
GMP TEA, Inc. October 2007 - December 2011
PAREXEL Consulting April 2002 - July 2008
Watson Pharmaceuticals / Schein Pharmaceuticals November 1995 - April 2002
Ciba-Geigy now known as Novartis June 1993 - September 1995
Skills
Cross-functional Team..., Training, Quality System, Instructional Design, FDA, Employee Training, Project Management, GMP, Learning Management..., Leadership, Sop, Performance Improvement, CAPA, Change Management, Pharmaceutical Industry, Consulting, Adult Learning..., Training Needs Analysis, Validation, Biopharmaceuticals, Technical Training, Management, Quality Assurance, Manufacturing, Coaching, Change Control, Quality Systems..., Performance Consulting, Database Admin, Medical Devices, Needs Analysis, Consent Decree, Human Performance..., Performance Support..., Employee Qualification, Qualified Trainer..., CBT /eLearning Design, Problem Solving, Risk Assessment, Leading Cross..., GMP Conference Agenda..., TrainTheTrainer, OJT, SOP
Education
Teachers College of Columbia University 1994 — 1996
MA, Adult Learning
The College of New Rochelle 1988 — 1991
MS with Honors, Educational Computing
State University of New York College at Oneonta 1982 — 1986
BS and BA, Math Ed and Mathematics
HPIS Consulting, Inc August 2008 - Present
SE FL Chapter of ATD May 2014 - Present
GMP TEA, Inc. October 2007 - Present
GMP TEA, Inc. January 2012 - June 2014
GMP TEA, Inc. February 2011 - December 2013
GMP TEA, Inc. January 2012 - November 2013
GMP TEA, Inc. October 2007 - December 2011
PAREXEL Consulting April 2002 - July 2008
Watson Pharmaceuticals / Schein Pharmaceuticals November 1995 - April 2002
Ciba-Geigy now known as Novartis June 1993 - September 1995
Skills
Cross-functional Team..., Training, Quality System, Instructional Design, FDA, Employee Training, Project Management, GMP, Learning Management..., Leadership, Sop, Performance Improvement, CAPA, Change Management, Pharmaceutical Industry, Consulting, Adult Learning..., Training Needs Analysis, Validation, Biopharmaceuticals, Technical Training, Management, Quality Assurance, Manufacturing, Coaching, Change Control, Quality Systems..., Performance Consulting, Database Admin, Medical Devices, Needs Analysis, Consent Decree, Human Performance..., Performance Support..., Employee Qualification, Qualified Trainer..., CBT /eLearning Design, Problem Solving, Risk Assessment, Leading Cross..., GMP Conference Agenda..., TrainTheTrainer, OJT, SOP
Education
Teachers College of Columbia University 1994 — 1996
MA, Adult Learning
The College of New Rochelle 1988 — 1991
MS with Honors, Educational Computing
State University of New York College at Oneonta 1982 — 1986
BS and BA, Math Ed and Mathematics
Shelly Henderson Shelly Henderson's PAREXEL Consulting Experience February 2008 - May 2010
Job Business Development Manager at NNE Pharmaplan
Industry Biotechnology
Experience
NNE Pharmaplan July 2011 - June 2012
ISPE Boston Area Chapter International Society of Pharmaceutical Engineering 1992 - 2011
PAREXEL Consulting February 2008 - May 2010
Strategic BioSolutions September 2004 - June 2007
Formatech July 2003 - June 2004
BioMetics January 1994 - February 1998
Skills
Biotechnology, GMP, Pharmaceutical Industry, Vaccines, V&V, Medical Devices, Protein Chemistry, Clinical Trials, Product Development, Strategy, Business Development, Formulation, Pharmaceutics, Monoclonal Antibodies, FDA, Technology Transfer, Biopharmaceuticals
Education
Babson College
Masters of Business Administration, Finance, Marketing
Emma Willard
Emma Willard
University of Vermont
BS, Medical Technology
NNE Pharmaplan July 2011 - June 2012
ISPE Boston Area Chapter International Society of Pharmaceutical Engineering 1992 - 2011
PAREXEL Consulting February 2008 - May 2010
Strategic BioSolutions September 2004 - June 2007
Formatech July 2003 - June 2004
BioMetics January 1994 - February 1998
Skills
Biotechnology, GMP, Pharmaceutical Industry, Vaccines, V&V, Medical Devices, Protein Chemistry, Clinical Trials, Product Development, Strategy, Business Development, Formulation, Pharmaceutics, Monoclonal Antibodies, FDA, Technology Transfer, Biopharmaceuticals
Education
Babson College
Masters of Business Administration, Finance, Marketing
Emma Willard
Emma Willard
University of Vermont
BS, Medical Technology
Annmarie Anderson's PAREXEL Consulting Experience November 2006 - March 2008
Job
Industry Events Services
Experience
Nickerson December 2014 - Present
GP Charity, Inc. December 2009 - Present
ATR/Treehouse March 2011 - November 2014
ATR Treehouse March 2011 - November 2014
Nowspeed Marketing December 2010 - March 2011
McNeil, Gray & Rice July 2009 - October 2010
Gray & Rice Public Relations March 2008 - July 2009
PAREXEL Consulting November 2006 - March 2008
Skills
Public Relations, SEM, Marketing Communications, SEO, Facebook, Press Releases, Trade Shows, Social Media Marketing, Advertising, Blogging, Social Media, Email Marketing, Management, Digital Marketing, Public Speaking, Marketing, Strategy, CRM
Education
Babson College 2002 — 2006
Business Administration, Marketing, Literary & Visual Arts
Nickerson December 2014 - Present
GP Charity, Inc. December 2009 - Present
ATR/Treehouse March 2011 - November 2014
ATR Treehouse March 2011 - November 2014
Nowspeed Marketing December 2010 - March 2011
McNeil, Gray & Rice July 2009 - October 2010
Gray & Rice Public Relations March 2008 - July 2009
PAREXEL Consulting November 2006 - March 2008
Skills
Public Relations, SEM, Marketing Communications, SEO, Facebook, Press Releases, Trade Shows, Social Media Marketing, Advertising, Blogging, Social Media, Email Marketing, Management, Digital Marketing, Public Speaking, Marketing, Strategy, CRM
Education
Babson College 2002 — 2006
Business Administration, Marketing, Literary & Visual Arts
Mike Falkow Mike Falkow's PAREXEL Consulting Experience January 2008 - May 2013
Job Independent Consultant
Industry Pharmaceuticals
Experience
The Lancer Group June 2013 - Present
Program Lead December 2014 - December 2014
Program Lead September 2014 - September 2014
PAREXEL Consulting January 2008 - May 2013
Tunnell Consulting 2003 - 2008
American Red Cross December 2001 - May 2003
Aventis Pharmaceuticals April 1996 - December 2001
US Food and Drug Administration 1972 - 1986
Skills
FDA, Pharmaceutical Industry, Validation, Biotechnology, Quality Systems, FDA Inspection Readiness, Compliance Remediation, Quality Assurance, Training, Quality System, 21 CFR Part 11, GxP, Medical Devices, GCP, Clinical Development, Aseptic Processing, GMP, Pharmaceutics, Clinical Trials, Regulatory Submissions, Regulatory Requirements, Biopharmaceuticals, Computer System..., Strategy, CAPA, Cleaning Validation, Cross-functional Team..., Change Control, Technology Transfer, GAMP, Pharmacovigilance, Regulatory Affairs, Sop, R&D, Lifesciences, Quality Control, Quality Auditing, Quality Management, V&V, GLP, Drug Development, IND, CRO, Medical Writing, Vaccines, ISO 13485, Oncology, CTMS, Commercialization, Protocol
Education
Temple University
Bachelor's degree, Biochemistry and Molecular Biology
The Lancer Group June 2013 - Present
Program Lead December 2014 - December 2014
Program Lead September 2014 - September 2014
PAREXEL Consulting January 2008 - May 2013
Tunnell Consulting 2003 - 2008
American Red Cross December 2001 - May 2003
Aventis Pharmaceuticals April 1996 - December 2001
US Food and Drug Administration 1972 - 1986
Skills
FDA, Pharmaceutical Industry, Validation, Biotechnology, Quality Systems, FDA Inspection Readiness, Compliance Remediation, Quality Assurance, Training, Quality System, 21 CFR Part 11, GxP, Medical Devices, GCP, Clinical Development, Aseptic Processing, GMP, Pharmaceutics, Clinical Trials, Regulatory Submissions, Regulatory Requirements, Biopharmaceuticals, Computer System..., Strategy, CAPA, Cleaning Validation, Cross-functional Team..., Change Control, Technology Transfer, GAMP, Pharmacovigilance, Regulatory Affairs, Sop, R&D, Lifesciences, Quality Control, Quality Auditing, Quality Management, V&V, GLP, Drug Development, IND, CRO, Medical Writing, Vaccines, ISO 13485, Oncology, CTMS, Commercialization, Protocol
Education
Temple University
Bachelor's degree, Biochemistry and Molecular Biology
Scott Bergeron's PAREXEL Consulting Experience July 2010 - July 2012
Job Vice President, World Wide Head, Customer Strategy at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL July 2012 - Present
PAREXEL Consulting July 2010 - July 2012
PAREXEL 2005 - July 2010
Forest Laboratories May 2002 - June 2005
Skills
Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, Strategic Planning, Account Management, Sales, Regulatory Affairs, GMP, Strategy, Clinical Research, Lifesciences, New Business Development, Drug Development, Product Launch, Commercialization, Biotechnology, Cross-functional Team..., Oncology, Management
Education
Fitchburg State College 1998 — 2001
MBA
Keene State College 1991 — 1995
BA, Business, Psychology
PAREXEL July 2012 - Present
PAREXEL Consulting July 2010 - July 2012
PAREXEL 2005 - July 2010
Forest Laboratories May 2002 - June 2005
Skills
Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, Strategic Planning, Account Management, Sales, Regulatory Affairs, GMP, Strategy, Clinical Research, Lifesciences, New Business Development, Drug Development, Product Launch, Commercialization, Biotechnology, Cross-functional Team..., Oncology, Management
Education
Fitchburg State College 1998 — 2001
MBA
Keene State College 1991 — 1995
BA, Business, Psychology
Christopher Church Christopher Church's PAREXEL Consulting Experience March 2013 - August 2014
Job Managing Director at Kineticos Life Sciences
Industry Management Consulting
Experience
Kineticos Life Sciences August 2014 - Present
PAREXEL Consulting March 2013 - August 2014
PAREXEL May 2011 - March 2013
Quintiles January 2010 - May 2011
American Institute of Healthcare & Fitness - Clinical Research Unit June 2005 - December 2009
Skills
Clinical Trials, Strategic Planning, Product Development, Clinical Research, Biotechnology, Business Strategy, Cross-functional Team..., Project Management
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School
MBA, Marketing (emphasis on strategic product development)
East Carolina University
BS, Biology, General
Kineticos Life Sciences August 2014 - Present
PAREXEL Consulting March 2013 - August 2014
PAREXEL May 2011 - March 2013
Quintiles January 2010 - May 2011
American Institute of Healthcare & Fitness - Clinical Research Unit June 2005 - December 2009
Skills
Clinical Trials, Strategic Planning, Product Development, Clinical Research, Biotechnology, Business Strategy, Cross-functional Team..., Project Management
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School
MBA, Marketing (emphasis on strategic product development)
East Carolina University
BS, Biology, General
William J. Winter William J. Winter's PAREXEL Consulting Experience January 2011 - April 2012
Job Vice President Technical at PAREXEL International
Industry Pharmaceuticals
Experience
PAREXEL International November 2014 - Present
PAREXEL International May 2012 - Present
PAREXEL Consulting January 2011 - April 2012
Science and Compliance LLC April 2008 - April 2012
Rondaxe Pharma April 2008 - April 2012
Bristol-Myers Squibb December 2001 - December 2007
Bristol-Myers Squibb November 1999 - December 2001
Bristol-Myers Squibb September 1997 - November 1999
Skills
Technology Transfer, Quality Assurance, Manufacturing, Project Management, CAPA, Quality System, Management, FDA, Pharmaceutical Industry, Product Development, Biotechnology, Analytical Chemistry, Regulatory Affairs, Process Engineering, Quality Control, Process Simulation, Chemistry, Strategy, Validation, GMP, Leadership, SOP, V&V
Education
TCU 1979 — 1981
National Science Foundation Postdoctoral Fellow, Synthesis and Study of Unique Organic Molecules with P. D. Bartlett
The Ohio State University 1973 — 1978
Ph.D., Organic Chemistry - Synthesis of Nucleoside Antibiotics
State University of New York College at Potsdam 1969 — 1973
Bachelors, Chemistry and Biology - Double Major with Honors
PAREXEL International November 2014 - Present
PAREXEL International May 2012 - Present
PAREXEL Consulting January 2011 - April 2012
Science and Compliance LLC April 2008 - April 2012
Rondaxe Pharma April 2008 - April 2012
Bristol-Myers Squibb December 2001 - December 2007
Bristol-Myers Squibb November 1999 - December 2001
Bristol-Myers Squibb September 1997 - November 1999
Skills
Technology Transfer, Quality Assurance, Manufacturing, Project Management, CAPA, Quality System, Management, FDA, Pharmaceutical Industry, Product Development, Biotechnology, Analytical Chemistry, Regulatory Affairs, Process Engineering, Quality Control, Process Simulation, Chemistry, Strategy, Validation, GMP, Leadership, SOP, V&V
Education
TCU 1979 — 1981
National Science Foundation Postdoctoral Fellow, Synthesis and Study of Unique Organic Molecules with P. D. Bartlett
The Ohio State University 1973 — 1978
Ph.D., Organic Chemistry - Synthesis of Nucleoside Antibiotics
State University of New York College at Potsdam 1969 — 1973
Bachelors, Chemistry and Biology - Double Major with Honors
Lisa Rysso-DeMaggio Lisa Rysso-DeMaggio's PAREXEL Consulting Experience June 2009 - September 2011
Job Senior Manager at Amgen
Industry Pharmaceuticals
Experience
Amgen January 2014 - Present
Raquelian Consulting September 2011 - January 2014
PAREXEL Consulting June 2009 - September 2011
Pfizer Inc March 2000 - May 2009
Pfizer Global R&D June 2001 - September 2003
Kresge Hearing Research Institute August 1998 - March 2000
University of Michigan June 1990 - March 2000
Skills
Africa, Regulatory Submissions, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, FDA, Generic Programming, Regulatory Requirements, Clinical Research, IND, Medical Devices, Strategy, GCP, 21 CFR Part 11, Quality Assurance, CRO
Education
The Johns Hopkins University 2010 — 2012
M.S., Bioscience Regulatory Affairs
University of Michigan 2000 — 2002
MS, Information Economics, Management and Policy
Eastern Michigan University 1989 — 1996
BS, Physics
Temple University
Amgen January 2014 - Present
Raquelian Consulting September 2011 - January 2014
PAREXEL Consulting June 2009 - September 2011
Pfizer Inc March 2000 - May 2009
Pfizer Global R&D June 2001 - September 2003
Kresge Hearing Research Institute August 1998 - March 2000
University of Michigan June 1990 - March 2000
Skills
Africa, Regulatory Submissions, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, FDA, Generic Programming, Regulatory Requirements, Clinical Research, IND, Medical Devices, Strategy, GCP, 21 CFR Part 11, Quality Assurance, CRO
Education
The Johns Hopkins University 2010 — 2012
M.S., Bioscience Regulatory Affairs
University of Michigan 2000 — 2002
MS, Information Economics, Management and Policy
Eastern Michigan University 1989 — 1996
BS, Physics
Temple University
Charles Collier Charles Collier's PAREXEL Consulting Experience 2001 - 2005
Job IT PM, CSV, and QA Professional
Industry Information Technology and Services
Experience
Gilead Sciences March 2014 - Present
Onyx Pharmaceuticals May 2013 - March 2014
Abbott Diabetes Care August 2012 - December 2012
US Data Management 2009 - April 2012
IT&E International September 2007 - November 2008
Washington Group International 2005 - 2006
PAREXEL Consulting 2001 - 2005
Skills
GxP, Computer System..., 21 CFR Part 11, Quality Auditing, Validation, Regulatory Affairs, FDA, Medical Devices, V&V, Sop, Quality Assurance, Project Management, Change Control, SDLC, Quality System, Requirements Analysis, CAPA, GMP, Information Technology, R&D, Pharmaceutical Industry, Project Planning, GAMP, Biotechnology, Lifesciences, ISO 13485, GLP, Technology Transfer, SOP, Life Sciences
Education
United States Naval Academy 1967 — 1971
B.S, Physics
US Naval Nuclear Power Schools
Gilead Sciences March 2014 - Present
Onyx Pharmaceuticals May 2013 - March 2014
Abbott Diabetes Care August 2012 - December 2012
US Data Management 2009 - April 2012
IT&E International September 2007 - November 2008
Washington Group International 2005 - 2006
PAREXEL Consulting 2001 - 2005
Skills
GxP, Computer System..., 21 CFR Part 11, Quality Auditing, Validation, Regulatory Affairs, FDA, Medical Devices, V&V, Sop, Quality Assurance, Project Management, Change Control, SDLC, Quality System, Requirements Analysis, CAPA, GMP, Information Technology, R&D, Pharmaceutical Industry, Project Planning, GAMP, Biotechnology, Lifesciences, ISO 13485, GLP, Technology Transfer, SOP, Life Sciences
Education
United States Naval Academy 1967 — 1971
B.S, Physics
US Naval Nuclear Power Schools
Raymond Lamy Raymond Lamy's PAREXEL Consulting Experience March 2004 - June 2007
Job President and Principal Consultant, ARCIEL, LLC
Industry Pharmaceuticals
Experience
ARCIEL, LLC July 2007 - Present
PAREXEL Consulting March 2004 - June 2007
Raymond C. Lamy Consulting June 2000 - February 2004
Situs Corporation October 1999 - May 2000
SkyePharma Inc. / DepoTech Corporation September 1994 - October 1999
Baxter Healthcare Corporation - Hyland Division February 1993 - September 1994
Bristol-Myers Squibb Company, Pharmaceutical Research Institute May 1986 - January 1993
Skills
Regulatory Affairs, Regulatory Submissions, Clinical Trials, FDA, Biotechnology, Drug Development, Validation, Manufacturing, Oncology, Pharmaceutical Industry, Clinical Development, Life Sciences, Medical Devices, Pharmaceutics, CRO, IND, Clinical Research, Regulatory Requirements, Biopharmaceuticals, Combination Products, NDA, Orphan Drugs, Breakthrough Therapy..., Fast-Track Designation, SOP, GCP, Technology Transfer, GMP, Management, Strategy, Therapeutic Areas, 21 CFR Part 11, GLP, CTMS, eCTD, 21CFR 312
Education
University of New Haven 1989 — 1991
MS, Computer Software Applications
University of Rhode Island 1981 — 1985
BS, Zoology / Psychology
ARCIEL, LLC July 2007 - Present
PAREXEL Consulting March 2004 - June 2007
Raymond C. Lamy Consulting June 2000 - February 2004
Situs Corporation October 1999 - May 2000
SkyePharma Inc. / DepoTech Corporation September 1994 - October 1999
Baxter Healthcare Corporation - Hyland Division February 1993 - September 1994
Bristol-Myers Squibb Company, Pharmaceutical Research Institute May 1986 - January 1993
Skills
Regulatory Affairs, Regulatory Submissions, Clinical Trials, FDA, Biotechnology, Drug Development, Validation, Manufacturing, Oncology, Pharmaceutical Industry, Clinical Development, Life Sciences, Medical Devices, Pharmaceutics, CRO, IND, Clinical Research, Regulatory Requirements, Biopharmaceuticals, Combination Products, NDA, Orphan Drugs, Breakthrough Therapy..., Fast-Track Designation, SOP, GCP, Technology Transfer, GMP, Management, Strategy, Therapeutic Areas, 21 CFR Part 11, GLP, CTMS, eCTD, 21CFR 312
Education
University of New Haven 1989 — 1991
MS, Computer Software Applications
University of Rhode Island 1981 — 1985
BS, Zoology / Psychology
Robert Barwick Robert Barwick's PAREXEL Consulting Experience January 2005 - December 2007
Job Quality & Regulatory Compliance in Pharmaceutical/Biotechnology/Medical Device Industries
Industry Pharmaceuticals
Experience
Executive Consultant to Pharmaceutical Industry January 2009 - Present
Watson Pharmaceuticals January 2008 - January 2009
PAREXEL Consulting January 2005 - December 2007
Par Pharmaceutical October 2004 - December 2004
Johnson & Johnson April 2000 - September 2004
Rhone-Poulenc Rorer (Sanofi Aventis) June 1995 - April 2000
GlaxoSmithKline March 1990 - June 1995
CryoLife, Inc. May 1987 - March 1990
MUREX Corporation 1986 - 1987
C.R. Bard, Inc., 1982 - 1986
Skills
FDA, GMP, CAPA, Pharmaceutical Industry, Regulatory Affairs, Validation, V&V, Change Control, 21 CFR Part 11, Technology Transfer, Sop, GxP, Biotechnology, GLP, Quality System, Aseptic Processing, Regulatory Submissions, IND, Regulatory Requirements, R&D, Strategy, Lifesciences, Medical Devices, Vaccines, Quality Assurance, Pharmaceutics, Quality Control, Biopharmaceuticals, Computer System..., Commercialization, Microbiology, GCP, Clinical Development, LIMS, CRO, Clinical Trials, Generic Programming, Drug Development, Pharmacovigilance, Clinical Research, SOP, Life Sciences
Education
University of North Carolina at Greensboro 1973 — 1975
MS, Biological Sciences (Microbiology, Virology and Biochemistry)
University of North Carolina at Greensboro 1971 — 1973
BA, Biology
Executive Consultant to Pharmaceutical Industry January 2009 - Present
Watson Pharmaceuticals January 2008 - January 2009
PAREXEL Consulting January 2005 - December 2007
Par Pharmaceutical October 2004 - December 2004
Johnson & Johnson April 2000 - September 2004
Rhone-Poulenc Rorer (Sanofi Aventis) June 1995 - April 2000
GlaxoSmithKline March 1990 - June 1995
CryoLife, Inc. May 1987 - March 1990
MUREX Corporation 1986 - 1987
C.R. Bard, Inc., 1982 - 1986
Skills
FDA, GMP, CAPA, Pharmaceutical Industry, Regulatory Affairs, Validation, V&V, Change Control, 21 CFR Part 11, Technology Transfer, Sop, GxP, Biotechnology, GLP, Quality System, Aseptic Processing, Regulatory Submissions, IND, Regulatory Requirements, R&D, Strategy, Lifesciences, Medical Devices, Vaccines, Quality Assurance, Pharmaceutics, Quality Control, Biopharmaceuticals, Computer System..., Commercialization, Microbiology, GCP, Clinical Development, LIMS, CRO, Clinical Trials, Generic Programming, Drug Development, Pharmacovigilance, Clinical Research, SOP, Life Sciences
Education
University of North Carolina at Greensboro 1973 — 1975
MS, Biological Sciences (Microbiology, Virology and Biochemistry)
University of North Carolina at Greensboro 1971 — 1973
BA, Biology
David Lowry David Lowry's PAREXEL Consulting Experience January 2007 - Present
Job Vice President, Parexel Consulting, Expert in cGMP for FDA regulated products
Industry Pharmaceuticals
Experience
PAREXEL Consulting January 2007 - Present
PAREXEL 2000 - 2007
American Red Cross, Biomedical Services 1994 - 2000
Ciba Vison 1991 - 1994
Baxter Healthcare 1982 - 1987
Baxter 1966 - 1982
Skills
GMP, FDA, Regulatory Affairs, CAPA, Quality System, Validation, Pharmaceutical Industry, Biotechnology, Quality Management, Quality Auditing, CRO, GLP, V&V, Medical Devices, Regulatory Requirements, Change Control, Sop, Pharmaceutics, Biopharmaceuticals, 21 CFR Part 11, Regulatory Submissions, Clinical Trials, Quality Assurance, Technology Transfer, Analytical Chemistry, Quality Control, GCP, Lifesciences, Drug Development, Clinical Development, Vaccines, Pharmacovigilance, IND, Oncology, SOP, CTMS
Education
Delta State University (NG) 1965 — 1973
BS, MBA, Biology and Managment
Delta State University 1963 — 1967
Biology/Biological Sciences, General
PAREXEL Consulting January 2007 - Present
PAREXEL 2000 - 2007
American Red Cross, Biomedical Services 1994 - 2000
Ciba Vison 1991 - 1994
Baxter Healthcare 1982 - 1987
Baxter 1966 - 1982
Skills
GMP, FDA, Regulatory Affairs, CAPA, Quality System, Validation, Pharmaceutical Industry, Biotechnology, Quality Management, Quality Auditing, CRO, GLP, V&V, Medical Devices, Regulatory Requirements, Change Control, Sop, Pharmaceutics, Biopharmaceuticals, 21 CFR Part 11, Regulatory Submissions, Clinical Trials, Quality Assurance, Technology Transfer, Analytical Chemistry, Quality Control, GCP, Lifesciences, Drug Development, Clinical Development, Vaccines, Pharmacovigilance, IND, Oncology, SOP, CTMS
Education
Delta State University (NG) 1965 — 1973
BS, MBA, Biology and Managment
Delta State University 1963 — 1967
Biology/Biological Sciences, General
Carol Bognar's PAREXEL Consulting Experience September 1999 - December 2009
Job Expert in clinical quality assurance audits, consulting and GCP training
Industry Research
Experience
Carol Bognar Consulting, LLC September 2011 - Present
The Weinberg Group May 2011 - August 2011
The Weinberg Group January 2010 - May 2011
PAREXEL Consulting September 1999 - December 2009
PRA International 1995 - 1999
Skills
GCP, SOP, Quality Assurance, Clinical, Compliance, Auditing, Sop, Clinical Research, Pharmaceutical Industry, Clinical Trials, CRO, Quality System, Clinical Development, Regulatory Submissions, CTMS, Regulatory Affairs, FDA, Validation, GxP, EDC, Drug Development, Pharmacovigilance
Education
James Madison University
BSN, Science, Nursing
University of Virginia
MSN, Science, Nursing
Carol Bognar Consulting, LLC September 2011 - Present
The Weinberg Group May 2011 - August 2011
The Weinberg Group January 2010 - May 2011
PAREXEL Consulting September 1999 - December 2009
PRA International 1995 - 1999
Skills
GCP, SOP, Quality Assurance, Clinical, Compliance, Auditing, Sop, Clinical Research, Pharmaceutical Industry, Clinical Trials, CRO, Quality System, Clinical Development, Regulatory Submissions, CTMS, Regulatory Affairs, FDA, Validation, GxP, EDC, Drug Development, Pharmacovigilance
Education
James Madison University
BSN, Science, Nursing
University of Virginia
MSN, Science, Nursing
Lotte McNamara, PhD Lotte McNamara, PhD's PAREXEL Consulting Experience April 2012 - November 2014
Job Principal Consultant at PAREXEL
Industry Biotechnology
Experience
PAREXEL November 2014 - Present
CASSS (an International Separation Science Society) January 2011 - Present
PAREXEL Consulting April 2012 - November 2014
LKM CMC Consulting - an affiliate of NW Biopharmaceutical Consulting March 2004 - March 2012
Cell Therapeutics, Inc. 2003 - 2004
Seattle Genetics 2001 - 2003
Immunex 1998 - 2001
ZymoGenetics 1991 - 1995
Skills
Biopharmaceuticals, IND, Pharmaceutical..., Quality by Design, Therapeutics, FDA, GMP, Validation, Regulatory Submissions, Biotechnology, Pharmaceuticals, Regulatory Affairs, Life Sciences, SOP, cGMP, Process Validation, eCTD, Monoclonal Antibodies, Quality Systems, R&D, Formulation Development, Process Development
Education
Danmarks Farmaceutiske Universitet 1994 — 1998
PhD, Pharmaceutical Sciences
Danmarks Farmaceutiske Universitet 1984 — 1991
MS, Pharmaceutical Sciences
University of Colorado Anschutz Medical Campus
PAREXEL November 2014 - Present
CASSS (an International Separation Science Society) January 2011 - Present
PAREXEL Consulting April 2012 - November 2014
LKM CMC Consulting - an affiliate of NW Biopharmaceutical Consulting March 2004 - March 2012
Cell Therapeutics, Inc. 2003 - 2004
Seattle Genetics 2001 - 2003
Immunex 1998 - 2001
ZymoGenetics 1991 - 1995
Skills
Biopharmaceuticals, IND, Pharmaceutical..., Quality by Design, Therapeutics, FDA, GMP, Validation, Regulatory Submissions, Biotechnology, Pharmaceuticals, Regulatory Affairs, Life Sciences, SOP, cGMP, Process Validation, eCTD, Monoclonal Antibodies, Quality Systems, R&D, Formulation Development, Process Development
Education
Danmarks Farmaceutiske Universitet 1994 — 1998
PhD, Pharmaceutical Sciences
Danmarks Farmaceutiske Universitet 1984 — 1991
MS, Pharmaceutical Sciences
University of Colorado Anschutz Medical Campus
Joseph Dorando Joseph Dorando's PAREXEL Consulting Experience June 2012 - Present
Job Complaints Manager at Prestige Brands
Industry Mechanical or Industrial Engineering
Experience
Prestige Brands February 2014 - Present
Parexel Consulting June 2012 - Present
Protocol Link July 2010 - Present
Lachman Consultants June 2008 - Present
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Wyeth Biotech June 2006 - January 2008
Wyeth May 1992 - January 2008
Skills
LIMS, Sop, 21 CFR Part 11, FDA, Validation, Quality Assurance, Management, Regulatory Affairs, Lifesciences, Pharmaceutical Industry, Medical Devices, Quality System, CAPA, Change Control, GLP, Computer System..., Quality Control, HPLC, Software Documentation, GCP, GMP, Cross-functional Team..., Quality Auditing, Document Management, Clinical Development
Education
Montclair State University 1973 — 1977
Bachelors Degree, Chemistry
Prestige Brands February 2014 - Present
Parexel Consulting June 2012 - Present
Protocol Link July 2010 - Present
Lachman Consultants June 2008 - Present
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Wyeth Biotech June 2006 - January 2008
Wyeth May 1992 - January 2008
Skills
LIMS, Sop, 21 CFR Part 11, FDA, Validation, Quality Assurance, Management, Regulatory Affairs, Lifesciences, Pharmaceutical Industry, Medical Devices, Quality System, CAPA, Change Control, GLP, Computer System..., Quality Control, HPLC, Software Documentation, GCP, GMP, Cross-functional Team..., Quality Auditing, Document Management, Clinical Development
Education
Montclair State University 1973 — 1977
Bachelors Degree, Chemistry
Matt Kiernan Matt Kiernan's PAREXEL Consulting Experience November 1999 - November 2004
Job Partner, Pharmica Consulting
Industry Pharmaceuticals
Experience
Pharmica Consulting 2005 - Present
Covance December 2005 - January 2007
Bristol Myers Squibb November 2005 - December 2006
Parexel Consulting November 1999 - November 2004
Merck 2000 - 2003
Omnicare Clinical Research 1997 - 1999
Skills
Document Management, Knowledge Management, Biotechnology, SDLC, Life Sciences, 21 CFR Part 11, Pharmaceuticals, Project Portfolio..., Process Improvement, Cross-functional Team..., Six Sigma, Business Process..., Change Management, Program Management, Project Planning, Business Intelligence, Healthcare, Business Management, Team Leadership, Strategic Planning, Resource Management, Strategy, Business Strategy, Clinical Development, Clinical Trials, Lifesciences, Management, Management Consulting, PMP, Pharmaceutical Industry, Process Simulation, Project Management, Quality Assurance, SharePoint, Validation, Consulting, CRO, Oncology, FDA, Drug Development, Clinical Research, GCP, Medical Devices, Regulatory Affairs, CTMS, SOP, Regulatory Submissions, Leadership
Education
Villanova University 2000 — 2002
MBA, Business
Purdue University 1995 — 1996
Chemistry
Temple University 1993 — 1995
B.S, Chemistry
University of Pittsburgh 1989 — 1994
Bachelor of Science, Business & Psychology
Pharmica Consulting 2005 - Present
Covance December 2005 - January 2007
Bristol Myers Squibb November 2005 - December 2006
Parexel Consulting November 1999 - November 2004
Merck 2000 - 2003
Omnicare Clinical Research 1997 - 1999
Skills
Document Management, Knowledge Management, Biotechnology, SDLC, Life Sciences, 21 CFR Part 11, Pharmaceuticals, Project Portfolio..., Process Improvement, Cross-functional Team..., Six Sigma, Business Process..., Change Management, Program Management, Project Planning, Business Intelligence, Healthcare, Business Management, Team Leadership, Strategic Planning, Resource Management, Strategy, Business Strategy, Clinical Development, Clinical Trials, Lifesciences, Management, Management Consulting, PMP, Pharmaceutical Industry, Process Simulation, Project Management, Quality Assurance, SharePoint, Validation, Consulting, CRO, Oncology, FDA, Drug Development, Clinical Research, GCP, Medical Devices, Regulatory Affairs, CTMS, SOP, Regulatory Submissions, Leadership
Education
Villanova University 2000 — 2002
MBA, Business
Purdue University 1995 — 1996
Chemistry
Temple University 1993 — 1995
B.S, Chemistry
University of Pittsburgh 1989 — 1994
Bachelor of Science, Business & Psychology
Rich Levy Rich Levy's PAREXEL Consulting Experience 2002 - 2005
Job Senior Vice President at Parenteral Drug Association
Industry Pharmaceuticals
Experience
Parenteral Drug Association (PDA) 2005 - Present
PAREXEL Consulting 2002 - 2005
Millipore Corporation January 1986 - December 2001
Skills
Aseptic Processing, Sterilization, Strategic Planning, Management, Publications, Pharmaceutical..., Regulatory Affairs, Pharmaceutics, Microbiology, Biotechnology, GMP, Lifesciences, FDA, Pharmaceutical Industry, Validation, Technology Transfer, Medical Devices, Commercialization, R&D, Sop, Filtration, 21 CFR Part 11, Clinical Development, Regulatory Requirements, GLP, Drug Development, Drug Discovery, Biopharmaceuticals, Clinical Trials, Change Control, Regulatory Submissions, Quality System, Formulation, Vaccines, V&V, GCP, CRO, Quality Assurance, Manufacturing, CAPA, Chromatography, Drug Delivery, ISO 13485, Analytical Chemistry, Cleaning Validation, IND, GxP, Quality Auditing, Biologics, Computer System...
Education
Worcester Polytechnic Institute, Worcester, MA 1981 — 1985
Ph.D., Environmental Health Sciences
Clark University, Worcester, MA 1972 — 1975
M.A., Biology
Colby College, Waterville, ME 1968 — 1972
B.A., Biology
Parenteral Drug Association (PDA) 2005 - Present
PAREXEL Consulting 2002 - 2005
Millipore Corporation January 1986 - December 2001
Skills
Aseptic Processing, Sterilization, Strategic Planning, Management, Publications, Pharmaceutical..., Regulatory Affairs, Pharmaceutics, Microbiology, Biotechnology, GMP, Lifesciences, FDA, Pharmaceutical Industry, Validation, Technology Transfer, Medical Devices, Commercialization, R&D, Sop, Filtration, 21 CFR Part 11, Clinical Development, Regulatory Requirements, GLP, Drug Development, Drug Discovery, Biopharmaceuticals, Clinical Trials, Change Control, Regulatory Submissions, Quality System, Formulation, Vaccines, V&V, GCP, CRO, Quality Assurance, Manufacturing, CAPA, Chromatography, Drug Delivery, ISO 13485, Analytical Chemistry, Cleaning Validation, IND, GxP, Quality Auditing, Biologics, Computer System...
Education
Worcester Polytechnic Institute, Worcester, MA 1981 — 1985
Ph.D., Environmental Health Sciences
Clark University, Worcester, MA 1972 — 1975
M.A., Biology
Colby College, Waterville, ME 1968 — 1972
B.A., Biology
J. Edgar Guerzon's PAREXEL Consulting Experience June 2012 - December 2012
Job Independent Consultant at GMP Scientific, Inc.
Industry Biotechnology
Experience
GMP Scientific, Inc. Independent ConsultantGMP Scientific, Inc.July 2015 - Present
Coquilicious Corp. March 2008 - Present
Pharma Tech Services® November 2007 - Present
PAREXEL January 2014 - March 2015
Parexel Consulting June 2012 - December 2012
Blu Caribe January 2012 - May 2012
Excellent Pharma Consulting November 2008 - December 2011
AMGEN - Puerto Rico May 2006 - October 2007
AMGEN - Rhode Island March 2005 - May 2006
Allergan - Waco, TX January 2003 - February 2005
Skills
FDA, Consent Decree, GMP, Aseptic Processing, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Change Control, CAPA, Technology Transfer, Validation, SOP, 21 CFR Part 11, Quality System, Quality Assurance, Sterility Assurance, Quality Control, GxP, HPLC, GC, Life Sciences, Deviation Management, V&V, Technical Writing, Deviations, Remediation, LIMS, GLP, Manufacturing, Analytical Chemistry, Cleaning Validation, Root Cause Analysis, Process Improvement, Laboratory, Management, Continuous Improvement, Vaccines, Microbiology, Cross-functional Team..., Quality Auditing, TrackWise, Leadership, Six Sigma
Education
Ramapo College of New Jersey
Bachelor of Applied Science (BASc), Molecular Biology
Don Bosco College Prep HS
HDS, Biology
GMP Scientific, Inc. Independent ConsultantGMP Scientific, Inc.July 2015 - Present
Coquilicious Corp. March 2008 - Present
Pharma Tech Services® November 2007 - Present
PAREXEL January 2014 - March 2015
Parexel Consulting June 2012 - December 2012
Blu Caribe January 2012 - May 2012
Excellent Pharma Consulting November 2008 - December 2011
AMGEN - Puerto Rico May 2006 - October 2007
AMGEN - Rhode Island March 2005 - May 2006
Allergan - Waco, TX January 2003 - February 2005
Skills
FDA, Consent Decree, GMP, Aseptic Processing, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Change Control, CAPA, Technology Transfer, Validation, SOP, 21 CFR Part 11, Quality System, Quality Assurance, Sterility Assurance, Quality Control, GxP, HPLC, GC, Life Sciences, Deviation Management, V&V, Technical Writing, Deviations, Remediation, LIMS, GLP, Manufacturing, Analytical Chemistry, Cleaning Validation, Root Cause Analysis, Process Improvement, Laboratory, Management, Continuous Improvement, Vaccines, Microbiology, Cross-functional Team..., Quality Auditing, TrackWise, Leadership, Six Sigma
Education
Ramapo College of New Jersey
Bachelor of Applied Science (BASc), Molecular Biology
Don Bosco College Prep HS
HDS, Biology
Tony Nakhla, Ph.D. Tony Nakhla, Ph.D.'s PAREXEL Consulting Experience October 2012 - March 2014
Job Director Regulatory Affairs at Premier Research
Industry Pharmaceuticals
Experience
Premier Research March 2014 - Present
University of New Mexico, College of Pharmacy September 2011 - Present
Parexel Consulting October 2012 - March 2014
Sandia Biotech, Inc. December 2010 - March 2014
Nakhla Consulting Services July 2010 - March 2014
Lovelace Respiratory Research Institute November 2009 - June 2010
Capstone Therapeutics January 2006 - July 2009
Tony Nakhla Consulting Services August 2003 - December 2005
Cardinal Health January 2000 - June 2003
Lipex Biomembranes, Inc. April 1998 - December 1999
Skills
HPLC, Biochemistry, Vaccines, Lyophilization, Life Sciences, IND, Therapeutics, cGMP, Biotechnology, Protein Chemistry, ELISA, Pharmaceuticals, Analytical Chemistry, Drug Delivery, Process Development, Mass Spectrometry, Chemistry, Characterization, Biopharmaceuticals, QC, Manufacturing, Technology Transfer, Clinical Development, Regulatory Affairs, Chromatography, Pharmaceutical Industry, GMP, LC-MS, Lifesciences, Formulation, Immunology
Education
Memorial University of Newfoundland 1985 — 1988
M.Sc., Biochemistry
Concordia University 1981 — 1984
B.Sc., Biochemistry
Memorial University of Newfoundland
Ph.D., Biochemistry
Premier Research March 2014 - Present
University of New Mexico, College of Pharmacy September 2011 - Present
Parexel Consulting October 2012 - March 2014
Sandia Biotech, Inc. December 2010 - March 2014
Nakhla Consulting Services July 2010 - March 2014
Lovelace Respiratory Research Institute November 2009 - June 2010
Capstone Therapeutics January 2006 - July 2009
Tony Nakhla Consulting Services August 2003 - December 2005
Cardinal Health January 2000 - June 2003
Lipex Biomembranes, Inc. April 1998 - December 1999
Skills
HPLC, Biochemistry, Vaccines, Lyophilization, Life Sciences, IND, Therapeutics, cGMP, Biotechnology, Protein Chemistry, ELISA, Pharmaceuticals, Analytical Chemistry, Drug Delivery, Process Development, Mass Spectrometry, Chemistry, Characterization, Biopharmaceuticals, QC, Manufacturing, Technology Transfer, Clinical Development, Regulatory Affairs, Chromatography, Pharmaceutical Industry, GMP, LC-MS, Lifesciences, Formulation, Immunology
Education
Memorial University of Newfoundland 1985 — 1988
M.Sc., Biochemistry
Concordia University 1981 — 1984
B.Sc., Biochemistry
Memorial University of Newfoundland
Ph.D., Biochemistry
Keith Tode, MBA's PAREXEL Consulting Experience June 2012 - June 2015
Job Global Business Director, IP & Science, Thomson Reuters
Industry Information Services
Experience
Thomson Reuters June 2015 - Present
PAREXEL Consulting June 2012 - June 2015
PAREXEL International Consulting January 2011 - June 2012
Citigroup Global Markets 2004 - 2009
John Hancock Direct Foreign Operations 1999 - 2004
Chiway Corp 1998 - 1999
Skills
International Business..., Emerging Markets, Commercialization, Regulatory Affairs, Customer Relations, Global Business..., Management Consulting, Life Sciences, Leadership, Strategy, Business Strategy, New Business Development, Strategic Planning, Global Marketing, International Marketing, Lifesciences, Product Launch, Training, Clinical Trials, Entrepreneurship, International Sales, Cross-functional Team..., Finance, Start-ups, Business Planning, Management, Healthcare, Biotechnology, Executive Management, Strategic Partnerships, Medical Devices, Product Development, Marketing, Pharmaceutical Industry, Competitive Analysis, Market Research, Competitive Intelligence, Strategic Thinking, Market Analysis, Due Diligence, Team Management, Business Development, FDA, Budgets, Oncology, Consulting, Business Intelligence, Health Economics, CRO, International Business
Education
Norwich University
MBA
University of New Hampshire
BA
Thomson Reuters June 2015 - Present
PAREXEL Consulting June 2012 - June 2015
PAREXEL International Consulting January 2011 - June 2012
Citigroup Global Markets 2004 - 2009
John Hancock Direct Foreign Operations 1999 - 2004
Chiway Corp 1998 - 1999
Skills
International Business..., Emerging Markets, Commercialization, Regulatory Affairs, Customer Relations, Global Business..., Management Consulting, Life Sciences, Leadership, Strategy, Business Strategy, New Business Development, Strategic Planning, Global Marketing, International Marketing, Lifesciences, Product Launch, Training, Clinical Trials, Entrepreneurship, International Sales, Cross-functional Team..., Finance, Start-ups, Business Planning, Management, Healthcare, Biotechnology, Executive Management, Strategic Partnerships, Medical Devices, Product Development, Marketing, Pharmaceutical Industry, Competitive Analysis, Market Research, Competitive Intelligence, Strategic Thinking, Market Analysis, Due Diligence, Team Management, Business Development, FDA, Budgets, Oncology, Consulting, Business Intelligence, Health Economics, CRO, International Business
Education
Norwich University
MBA
University of New Hampshire
BA
Tom Greskovich's PAREXEL Consulting Experience March 2005 - July 2008
Job
Industry Pharmaceuticals
Experience
T. Greskovich, Ltd August 2008 - Present
Parexel Consulting March 2005 - July 2008
Baxter Healthcare January 1978 - June 2004
Baxter Healthcare 1992 - 1998
Skills
Quality System, CAPA, Quality Assurance, FDA, Medical Devices, Regulatory Requirements, Quality Control, GMP, Validation, Change Control, 21 CFR Part 11, Aseptic Processing, Regulatory Affairs, V&V, Pharmaceutical Industry, Sop, GxP, Computer System..., Pharmaceutics, Design Control, CRO, Six Sigma, Regulatory Submissions, ISO 13485, GLP, Biotechnology, Laboratory, GCP, Vaccines, R&D, GAMP, Product Quality, Biopharmaceuticals, Pharmacovigilance, Commercialization, CTMS, Quality Management, Process Simulation, Document Management, ISO, Quality Auditing, Microbiology, Technology Transfer, LIMS, Lifesciences, Clinical Trials, Clinical Development, Analytical Chemistry, Manufacturing, Drug Development
Education
Indiana University-Northwest 1982 — 1986
MBA
Indiana University Bloomington 1967 — 1971
BS
T. Greskovich, Ltd August 2008 - Present
Parexel Consulting March 2005 - July 2008
Baxter Healthcare January 1978 - June 2004
Baxter Healthcare 1992 - 1998
Skills
Quality System, CAPA, Quality Assurance, FDA, Medical Devices, Regulatory Requirements, Quality Control, GMP, Validation, Change Control, 21 CFR Part 11, Aseptic Processing, Regulatory Affairs, V&V, Pharmaceutical Industry, Sop, GxP, Computer System..., Pharmaceutics, Design Control, CRO, Six Sigma, Regulatory Submissions, ISO 13485, GLP, Biotechnology, Laboratory, GCP, Vaccines, R&D, GAMP, Product Quality, Biopharmaceuticals, Pharmacovigilance, Commercialization, CTMS, Quality Management, Process Simulation, Document Management, ISO, Quality Auditing, Microbiology, Technology Transfer, LIMS, Lifesciences, Clinical Trials, Clinical Development, Analytical Chemistry, Manufacturing, Drug Development
Education
Indiana University-Northwest 1982 — 1986
MBA
Indiana University Bloomington 1967 — 1971
BS
Kirsten Morasco's PAREXEL Consulting Experience April 2000 - March 2004
Job Owner, KLM Consulting
Industry Management Consulting
Experience
KLM Consulting April 2004 - Present
Parexel Consulting April 2000 - March 2004
Barnett International 2000 - 2004
Wyeth Pharmaceuticals September 1997 - April 2000
McNeil Consumer Products January 1995 - August 1997
Skills
Process Improvement, Change Management, Management Consulting, Clinical, Six Sigma, Strategic Planning, Clinical Research, Program Management, Project Management, Management, Cross-functional Team..., Strategy, Business Process..., Business Analysis, Business Strategy, Coaching, CRM, Outsourcing, Business Process, Pharmaceutical Industry, Consulting
Education
The Catholic University of America 1989 — 1993
Bachelor of Science (BS), Biology, General
Mount Saint Joseph Academy 1985 — 1989
KLM Consulting April 2004 - Present
Parexel Consulting April 2000 - March 2004
Barnett International 2000 - 2004
Wyeth Pharmaceuticals September 1997 - April 2000
McNeil Consumer Products January 1995 - August 1997
Skills
Process Improvement, Change Management, Management Consulting, Clinical, Six Sigma, Strategic Planning, Clinical Research, Program Management, Project Management, Management, Cross-functional Team..., Strategy, Business Process..., Business Analysis, Business Strategy, Coaching, CRM, Outsourcing, Business Process, Pharmaceutical Industry, Consulting
Education
The Catholic University of America 1989 — 1993
Bachelor of Science (BS), Biology, General
Mount Saint Joseph Academy 1985 — 1989
Teri Johnson, RAC's PAREXEL Consulting Experience March 2003 - September 2007
Job Sr. Director, Regulatory Affairs at Orexigen Therapeutics
Industry Pharmaceuticals
Experience
Orexigen Therapeutics January 2014 - Present
Orexigen Therapeutics, Inc. March 2008 - December 2013
PAREXEL Consulting March 2003 - September 2007
PAREXEL International March 2002 - February 2003
Miravant Medical Technologies 1996 - March 2002
Norton-Lambert 1993 - 1996
Skills
Regulatory Submissions, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Sop, Oncology, Drug Development, Therapeutic Areas, IND, Cross-functional Team..., Protocol, Clinical Research, Strategy, Neurology, Clinical Development
Education
University of California, Santa Barbara 1991 — 1995
Sociology
Orexigen Therapeutics January 2014 - Present
Orexigen Therapeutics, Inc. March 2008 - December 2013
PAREXEL Consulting March 2003 - September 2007
PAREXEL International March 2002 - February 2003
Miravant Medical Technologies 1996 - March 2002
Norton-Lambert 1993 - 1996
Skills
Regulatory Submissions, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Sop, Oncology, Drug Development, Therapeutic Areas, IND, Cross-functional Team..., Protocol, Clinical Research, Strategy, Neurology, Clinical Development
Education
University of California, Santa Barbara 1991 — 1995
Sociology
Amy Caruso's PAREXEL Consulting Experience February 2002 - September 2006
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals Corporation 2008 - 2011
Celgene September 2006 - August 2007
PAREXEL Consulting February 2002 - September 2006
PAREXEL Consulting July 2000 - February 2002
Novartis January 1999 - July 2000
Novartis September 1997 - January 1999
Skills
Clinical Trials, Oncology, FDA, Research, Program Management, Biotechnology, Clinical Research, Clinical Data Management, CTMS, Quality Assurance, Strategic Planning, Data Management, Drug Development, Sop, Software Documentation, Pharmaceutical Industry
Education
Montclair State University 1992 — 1996
Bachelor of Arts, Communication Studies
Parsippany Hills HS
Novartis Pharmaceuticals Corporation 2008 - 2011
Celgene September 2006 - August 2007
PAREXEL Consulting February 2002 - September 2006
PAREXEL Consulting July 2000 - February 2002
Novartis January 1999 - July 2000
Novartis September 1997 - January 1999
Skills
Clinical Trials, Oncology, FDA, Research, Program Management, Biotechnology, Clinical Research, Clinical Data Management, CTMS, Quality Assurance, Strategic Planning, Data Management, Drug Development, Sop, Software Documentation, Pharmaceutical Industry
Education
Montclair State University 1992 — 1996
Bachelor of Arts, Communication Studies
Parsippany Hills HS
David Hyde, CPIP's PAREXEL Consulting Experience September 1991 - September 2004
Job GMP Compliance Manager at Lantheus Medical Imaging, Inc.
Industry Pharmaceuticals
Experience
Lantheus Medical Imaging, Inc. April 2011 - Present
Mount Wachusett Community College - Biotech Programs September 2010 - April 2011
ProPharma Group November 2009 - April 2010
Foster-Miller, Inc. August 2007 - November 2009
LearnWright, Inc. October 2005 - April 2007
Thermo Electron Corporation October 2004 - October 2005
PAREXEL Consulting September 1991 - September 2004
Millipore Corporation 1989 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Skills
Validation, Pharmaceutical Industry, Quality Assurance, FDA, GMP, Process Improvement, V&V, Biotechnology, Management, Software Documentation, CAPA, Quality Auditing, Medical Devices, Manufacturing, Sop, Quality System, Business Development, Project Management, Program Management
Education
Colby College 1979 — 1983
BA, Biology
Lantheus Medical Imaging, Inc. April 2011 - Present
Mount Wachusett Community College - Biotech Programs September 2010 - April 2011
ProPharma Group November 2009 - April 2010
Foster-Miller, Inc. August 2007 - November 2009
LearnWright, Inc. October 2005 - April 2007
Thermo Electron Corporation October 2004 - October 2005
PAREXEL Consulting September 1991 - September 2004
Millipore Corporation 1989 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Skills
Validation, Pharmaceutical Industry, Quality Assurance, FDA, GMP, Process Improvement, V&V, Biotechnology, Management, Software Documentation, CAPA, Quality Auditing, Medical Devices, Manufacturing, Sop, Quality System, Business Development, Project Management, Program Management
Education
Colby College 1979 — 1983
BA, Biology
Kathleen Linder, PMP, CQA's PAREXEL Consulting Experience 2006 - Present
Job Manager, Strategic Resourcing at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL Consulting 2006 - Present
Sepracor May 2004 - January 2006
Biogen Idec August 1998 - May 2004
Biogen August 1998 - August 2000
Education
Northeastern University 2009 — 2009
Project Management
Bentley University 1998 — 2002
MBA
Worcester Polytechnic Institute 1994 — 1998
PAREXEL Consulting 2006 - Present
Sepracor May 2004 - January 2006
Biogen Idec August 1998 - May 2004
Biogen August 1998 - August 2000
Education
Northeastern University 2009 — 2009
Project Management
Bentley University 1998 — 2002
MBA
Worcester Polytechnic Institute 1994 — 1998
Bhavdeep Shah's PAREXEL Consulting Experience March 2011 - Present
Job Consultant
Industry Pharmaceuticals
Experience
PAREXEL Consulting March 2011 - Present
Cosmopharm Inc. 2006 - 2011
Acusphere, Inc. 2000 - 2005
Pharma/Biotech Companies 1997 - 2000
Mylan Technologies 1994 - 1997
Skills
Change Control, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry
Education
Hult International Business School 1997 — 1998
MSM
Clarkson University 1989 — 1994
Ph.D, Chemistry
PAREXEL Consulting March 2011 - Present
Cosmopharm Inc. 2006 - 2011
Acusphere, Inc. 2000 - 2005
Pharma/Biotech Companies 1997 - 2000
Mylan Technologies 1994 - 1997
Skills
Change Control, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry
Education
Hult International Business School 1997 — 1998
MSM
Clarkson University 1989 — 1994
Ph.D, Chemistry
Martin E. Zuzulo's PAREXEL Consulting Experience October 2007 - January 2009
Job Client Services Partner at Skyland Analytics LLC
Industry Pharmaceuticals
Experience
Skyland Analytics LLC June 2015 - Present
Accenture October 2012 - May 2015
Proficio Consulting Group November 2010 - October 2012
PAREXEL February 2009 - October 2010
PAREXEL Consulting October 2007 - January 2009
IBM Global Business Services 2002 - 2007
PwC March 1996 - January 2002
KPMG US March 1995 - February 1996
Day & Zimmermann June 1993 - March 1995
Biogen September 1987 - June 1993
Skills
Strategic Planning, Account Planning, Pharmaceutical Industry, Lifesciences, Biotechnology, Clinical Development, Business Strategy, Management Consulting, Cross-functional Team..., Pharmaceutics, Clinical Trials, Business Development, Outsourcing, Competitive Intelligence, Medical Devices, CRO, Strategy, Data Management, Process Improvement, Change Management
Education
State University of New York at Stony Brook 1984 — 1986
BA BS, Biochemistry, Molecular Biology, Psychology
Skyland Analytics LLC June 2015 - Present
Accenture October 2012 - May 2015
Proficio Consulting Group November 2010 - October 2012
PAREXEL February 2009 - October 2010
PAREXEL Consulting October 2007 - January 2009
IBM Global Business Services 2002 - 2007
PwC March 1996 - January 2002
KPMG US March 1995 - February 1996
Day & Zimmermann June 1993 - March 1995
Biogen September 1987 - June 1993
Skills
Strategic Planning, Account Planning, Pharmaceutical Industry, Lifesciences, Biotechnology, Clinical Development, Business Strategy, Management Consulting, Cross-functional Team..., Pharmaceutics, Clinical Trials, Business Development, Outsourcing, Competitive Intelligence, Medical Devices, CRO, Strategy, Data Management, Process Improvement, Change Management
Education
State University of New York at Stony Brook 1984 — 1986
BA BS, Biochemistry, Molecular Biology, Psychology
Christie Hamel's PAREXEL Consulting Experience 2000 - 2008
Job Regulatory Operations Assistant Director at Isis Pharmaceuticals
Industry Pharmaceuticals
Experience
Isis Pharmaceuticals January 2013 - Present
Isis Pharmaceuticals April 2010 - January 2013
Datafarm Inc November 2007 - April 2010
PAREXEL Consulting 2000 - 2008
PAREXEL International January 2003 - November 2007
Vical January 2000 - January 2003
Skills
Regulatory Affairs, GCP, Clinical Trials, FDA, Sop, Drug Development, IND, eCTD, Protocol, Clinical Research, Clinical Study Design, NDA, Regulatory Submissions, Pharmaceutical Industry, IRB, Biotechnology
Education
Albion College 1995 — 1999
Isis Pharmaceuticals January 2013 - Present
Isis Pharmaceuticals April 2010 - January 2013
Datafarm Inc November 2007 - April 2010
PAREXEL Consulting 2000 - 2008
PAREXEL International January 2003 - November 2007
Vical January 2000 - January 2003
Skills
Regulatory Affairs, GCP, Clinical Trials, FDA, Sop, Drug Development, IND, eCTD, Protocol, Clinical Research, Clinical Study Design, NDA, Regulatory Submissions, Pharmaceutical Industry, IRB, Biotechnology
Education
Albion College 1995 — 1999
Miriam Ferrell's PAREXEL Consulting Experience August 1996 - July 2008
Job QA Services Validation Section Manager at AbbVie Bioresearch Center
Industry Pharmaceuticals
Experience
AbbVie Bioresearch Center January 2013 - Present
Abbott Bioresearch Center November 2010 - December 2012
Abbott Bioresearch Center March 2009 - November 2010
PAREXEL Consulting August 1996 - July 2008
Skills
CAPA, 21 CFR Part 11, Validation, Change Control, GMP, FDA, GxP, Computer System..., Sop, Pharmaceutical Industry, Quality System, V&V
Education
Massachusetts Institute of Technology 1992 — 1996
BS, Chemical Engineering
AbbVie Bioresearch Center January 2013 - Present
Abbott Bioresearch Center November 2010 - December 2012
Abbott Bioresearch Center March 2009 - November 2010
PAREXEL Consulting August 1996 - July 2008
Skills
CAPA, 21 CFR Part 11, Validation, Change Control, GMP, FDA, GxP, Computer System..., Sop, Pharmaceutical Industry, Quality System, V&V
Education
Massachusetts Institute of Technology 1992 — 1996
BS, Chemical Engineering
Saumya Nathan's PAREXEL Consulting Experience June 2011 - Present
Job Consultant Regulatory Consultant
Industry Biotechnology
Experience
PAREXEL Consulting June 2011 - Present
PAREXEL April 2008 - May 2011
The EMMES Corporation 2006 - 2008
Emergent BioSolutions January 2004 - August 2006
Baxter BioScience 2000 - 2003
Skills
Clinical Trials, Data Management, Protein Purification, FDA, CRO, GLP, Vaccines, EDC, GMP, Clinical Data Management, Regulatory Submissions, Technology Transfer, Regulatory Affairs, Validation, Sop, Change Control, Infectious Diseases, Drug Development, Protocol, GCP, IND, CTMS, Clinical Development, Oncology, 21 CFR Part 11, Biopharmaceuticals, Clinical Study Design, Biotechnology, Pharmacovigilance, Lifesciences, Pharmaceutical Industry, Business Strategy, Life Sciences, SOP
Education
Auburn University 1987 — 1990
M.S., Muscle Biology, Animal Sciences
University of Mumbai
M.Sc., Biophysics
University of Mumbai
B.Sc., Microbiology
St. Teresa's Convent High School
Microbiology
PAREXEL Consulting June 2011 - Present
PAREXEL April 2008 - May 2011
The EMMES Corporation 2006 - 2008
Emergent BioSolutions January 2004 - August 2006
Baxter BioScience 2000 - 2003
Skills
Clinical Trials, Data Management, Protein Purification, FDA, CRO, GLP, Vaccines, EDC, GMP, Clinical Data Management, Regulatory Submissions, Technology Transfer, Regulatory Affairs, Validation, Sop, Change Control, Infectious Diseases, Drug Development, Protocol, GCP, IND, CTMS, Clinical Development, Oncology, 21 CFR Part 11, Biopharmaceuticals, Clinical Study Design, Biotechnology, Pharmacovigilance, Lifesciences, Pharmaceutical Industry, Business Strategy, Life Sciences, SOP
Education
Auburn University 1987 — 1990
M.S., Muscle Biology, Animal Sciences
University of Mumbai
M.Sc., Biophysics
University of Mumbai
B.Sc., Microbiology
St. Teresa's Convent High School
Microbiology
Bruce Mann's PAREXEL Consulting Experience March 2012 - November 2012
Job Independent Consultant at Samsung BioLogics
Industry Pharmaceuticals
Experience
Samsung BioLogics March 2015 - Present
Piramal Critical Care March 2014 - November 2014
PAREXEL December 2012 - February 2014
PAREXEL Consulting March 2012 - November 2012
PIRAMAL CRITICAL CARE April 2010 - March 2012
PIRAMAL CRITICAL CARE June 2009 - March 2010
MINRAD INC June 2008 - May 2009
MINRAD Inc October 2007 - May 2008
MINRAD Inc. April 2004 - September 2007
MINRAD Inc. September 2003 - March 2004
Skills
Change Control, FDA, Validation, GMP, CAPA, Quality Assurance, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, Quality Management, Biopharmaceuticals, Computer System..., GxP, Aseptic Processing, Quality System, Manufacturing, Cleaning Validation, ISO 13485, Continuous Improvement, Quality Control, Sop, V&V, Regulatory Submissions, 21 CFR Part 11, Six Sigma, Regulatory Requirements, Medical Devices, Quality Auditing, FDA GMP, GLP, Technology Transfer, Pharmaceutics, ICH guidelines, LIMS, 21 CFR, Trackwise, IND, SOP development, Vaccines, Sterilization, Pharmacovigilance, ANDA, Generic Programming, SOP, GCP, TrackWise
Education
University of Phoenix
Bachelor's of Science in Environmental Science, 3.73
Samsung BioLogics March 2015 - Present
Piramal Critical Care March 2014 - November 2014
PAREXEL December 2012 - February 2014
PAREXEL Consulting March 2012 - November 2012
PIRAMAL CRITICAL CARE April 2010 - March 2012
PIRAMAL CRITICAL CARE June 2009 - March 2010
MINRAD INC June 2008 - May 2009
MINRAD Inc October 2007 - May 2008
MINRAD Inc. April 2004 - September 2007
MINRAD Inc. September 2003 - March 2004
Skills
Change Control, FDA, Validation, GMP, CAPA, Quality Assurance, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, Quality Management, Biopharmaceuticals, Computer System..., GxP, Aseptic Processing, Quality System, Manufacturing, Cleaning Validation, ISO 13485, Continuous Improvement, Quality Control, Sop, V&V, Regulatory Submissions, 21 CFR Part 11, Six Sigma, Regulatory Requirements, Medical Devices, Quality Auditing, FDA GMP, GLP, Technology Transfer, Pharmaceutics, ICH guidelines, LIMS, 21 CFR, Trackwise, IND, SOP development, Vaccines, Sterilization, Pharmacovigilance, ANDA, Generic Programming, SOP, GCP, TrackWise
Education
University of Phoenix
Bachelor's of Science in Environmental Science, 3.73
Irina Colligon's PAREXEL Consulting Experience October 2001 - December 2007
Job Consultant at Self Employed
Industry Pharmaceuticals
Experience
Self Employed January 2008 - Present
SQA 2006 - 2013
Barnett Educational Services 2012 - 2012
Shire Pharmaceuticals 2010 - 2012
YouEncore 2010 - 2012
Shire Pharmaceuticals 2010 - 2012
MARSQA 1999 - 2012
Johnson & Johnson 2010 - 2011
PAREXEL Consulting October 2001 - December 2007
Johnson & Johnson 2002 - 2006
Skills
FDA, 21 CFR Part 11, GCP, Validation, Pharmaceutical Industry, Clinical Research, Sop, Quality Assurance, Regulatory Affairs, Software Documentation, Clinical Development, Clinical Trials, Lifesciences, Medical Devices, Pharmaceutics, GxP, Regulatory Submissions, GLP, Change Control, GMP, Drug Development, Computer System..., CAPA, Biopharmaceuticals, Biotechnology, Quality Management, CRO, Technology Transfer, Vaccines, Oncology, LIMS, Regulatory Requirements, V&V, Quality System, SOP, Life Sciences
Education
University of Pennsylvania 1975 — 1978
BA, Biology
Moscow Medical Stomatological Institute (Medical) 1973 — 1975
Self Employed January 2008 - Present
SQA 2006 - 2013
Barnett Educational Services 2012 - 2012
Shire Pharmaceuticals 2010 - 2012
YouEncore 2010 - 2012
Shire Pharmaceuticals 2010 - 2012
MARSQA 1999 - 2012
Johnson & Johnson 2010 - 2011
PAREXEL Consulting October 2001 - December 2007
Johnson & Johnson 2002 - 2006
Skills
FDA, 21 CFR Part 11, GCP, Validation, Pharmaceutical Industry, Clinical Research, Sop, Quality Assurance, Regulatory Affairs, Software Documentation, Clinical Development, Clinical Trials, Lifesciences, Medical Devices, Pharmaceutics, GxP, Regulatory Submissions, GLP, Change Control, GMP, Drug Development, Computer System..., CAPA, Biopharmaceuticals, Biotechnology, Quality Management, CRO, Technology Transfer, Vaccines, Oncology, LIMS, Regulatory Requirements, V&V, Quality System, SOP, Life Sciences
Education
University of Pennsylvania 1975 — 1978
BA, Biology
Moscow Medical Stomatological Institute (Medical) 1973 — 1975
Sarika Arora, MPH's PAREXEL Consulting Experience October 2014 - Present
Job Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL Consulting October 2014 - Present
HERON Evidence Development / HERON Commercialization, a PAREXEL Company July 2011 - September 2014
HERON Evidence Development June 2010 - June 2012
Analytica International July 2007 - June 2010
Skills
Health Economics, Healthcare Reimbursement, HTA, Strategy, Business Development, Biotechnology, Pricing, Pharmacovigilance, Sales Effectiveness, Drug Development, Clinical Development, Biopharmaceuticals, Infectious Diseases, Management, Lifesciences
Education
University of Medicine and Dentistry of New Jersey 2005 — 2007
MPH, Dental Public Health
Rutgers University-New Brunswick 2001 — 2005
BS, Public Health, Chemistry, Psychology
PAREXEL Consulting October 2014 - Present
HERON Evidence Development / HERON Commercialization, a PAREXEL Company July 2011 - September 2014
HERON Evidence Development June 2010 - June 2012
Analytica International July 2007 - June 2010
Skills
Health Economics, Healthcare Reimbursement, HTA, Strategy, Business Development, Biotechnology, Pricing, Pharmacovigilance, Sales Effectiveness, Drug Development, Clinical Development, Biopharmaceuticals, Infectious Diseases, Management, Lifesciences
Education
University of Medicine and Dentistry of New Jersey 2005 — 2007
MPH, Dental Public Health
Rutgers University-New Brunswick 2001 — 2005
BS, Public Health, Chemistry, Psychology
Pamela Aiello's PAREXEL Consulting Experience March 2010 - Present
Job Sr. Consultant at PAREXEL International
Industry Pharmaceuticals
Experience
PAREXEL Consulting March 2010 - Present
Boston Scientific September 2008 - March 2010
PAREXEL Consulting May 2003 - September 2008
Wyeth 2001 - April 2003
Fisons 1981 - 1995
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Oncology, GCP, FDA, Vaccines, Medical Devices, 21 CFR Part 11, GLP, Biotechnology, GMP, Immunology, Quality Assurance, Medical Writing, Clinical Research, Laboratory, Therapeutic Areas, Sop
Education
State University of New York Empire State College
BS, chemistry, management
PAREXEL Consulting March 2010 - Present
Boston Scientific September 2008 - March 2010
PAREXEL Consulting May 2003 - September 2008
Wyeth 2001 - April 2003
Fisons 1981 - 1995
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Oncology, GCP, FDA, Vaccines, Medical Devices, 21 CFR Part 11, GLP, Biotechnology, GMP, Immunology, Quality Assurance, Medical Writing, Clinical Research, Laboratory, Therapeutic Areas, Sop
Education
State University of New York Empire State College
BS, chemistry, management
John An's PAREXEL Consulting Experience March 2013 - Present
Job Manager at PAREXEL Consulting
Industry Pharmaceuticals
Experience
PAREXEL Consulting March 2013 - Present
Skills
Oncology, Clinical Trials, FDA, Pharmaceutics, Drug Delivery, Cardiology, Formulation, Regulatory Submissions, Pharmacy, Clinical Operations, Pharmacology, R&D, Sop, Regulatory Requirements, Medical Writing, SOP, Pharmaceutical Industry, Drug Development, Clinical Development
Education
University of North Carolina at Chapel Hill 2001 — 2008
Doctor of Philosophy, Pharmaceutical Sciences
University of North Carolina at Chapel Hill 1997 — 2001
Doctor of Pharmacy (PharmD), Preclinical Studies
PAREXEL Consulting March 2013 - Present
Skills
Oncology, Clinical Trials, FDA, Pharmaceutics, Drug Delivery, Cardiology, Formulation, Regulatory Submissions, Pharmacy, Clinical Operations, Pharmacology, R&D, Sop, Regulatory Requirements, Medical Writing, SOP, Pharmaceutical Industry, Drug Development, Clinical Development
Education
University of North Carolina at Chapel Hill 2001 — 2008
Doctor of Philosophy, Pharmaceutical Sciences
University of North Carolina at Chapel Hill 1997 — 2001
Doctor of Pharmacy (PharmD), Preclinical Studies
Bob Ketterer's PAREXEL Consulting Experience January 2000 - January 2004
Job President at PharmaCOM LLC
Industry Pharmaceuticals
Experience
PharmaCOM LLC January 2005 - Present
Fast Track Systems January 2004 - December 2005
PAREXEL Consulting January 2000 - January 2004
Accenture January 1995 - January 2000
KPMG Peat Marwick January 1993 - January 1995
US Army January 1983 - January 1993
Skills
Team Leadership, Clinical Research, Program Management, Executive Management, Negotiation, Contract Negotiation, Metrics, Planning, Management Consulting, Clinical, Research, Entrepreneur, FDA, Professional Services, Coaching, Clinical Trial..., Engagement, Team Building, Clinical Trials, Change Management, Government, Entrepreneurship
Education
Lehigh University 1990 — 1991
Master of Science, Management Science
Pennsylvania State University 1979 — 1983
Bachelor of Science, Business Economics
PharmaCOM LLC January 2005 - Present
Fast Track Systems January 2004 - December 2005
PAREXEL Consulting January 2000 - January 2004
Accenture January 1995 - January 2000
KPMG Peat Marwick January 1993 - January 1995
US Army January 1983 - January 1993
Skills
Team Leadership, Clinical Research, Program Management, Executive Management, Negotiation, Contract Negotiation, Metrics, Planning, Management Consulting, Clinical, Research, Entrepreneur, FDA, Professional Services, Coaching, Clinical Trial..., Engagement, Team Building, Clinical Trials, Change Management, Government, Entrepreneurship
Education
Lehigh University 1990 — 1991
Master of Science, Management Science
Pennsylvania State University 1979 — 1983
Bachelor of Science, Business Economics
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY