Takeda Global Research and Development
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Takeda Global Research and Development Employees
Employee
Years
Job
Industry
Lucia Yaroch Lucia Yaroch's Takeda Global Research and Development Experience 2005 - 2008
Job Independent Medical Writer at Yaroch Consulting, LLC
Industry Pharmaceuticals
Experience
Yaroch Consulting, LLC 2015 - Present
Amgen 2011 - 2014
Amgen 2008 - 2011
Takeda Global Research and Development 2005 - 2008
Pfizer Global Research and Development 2003 - 2005
Pfizer Global Research and Development 2001 - 2003
Parke-Davis Pharmaceutical Research/Pfizer Global Research and Development 1999 - 2001
Parke-Davis Pharmaceutical Research, contractor through Terre Clinical Research 1998 - 1999
STATPROBE, Inc 1996 - 1998
Skills
Pharmaceutical Industry, Regulatory Submissions, NDA, Drug Development, Clinical Research, Clinical Study Design, Clinical Trials, Clinical Development, SAS, Neuroscience, Medical Writing, FDA, GCP, IND, Drug Metabolism, CTMS, Pharmacology, Regulatory Affairs, Data Management, CRO, Infectious Diseases, Diabetes, Therapeutic Areas, Biopharmaceuticals, Medical Affairs, Pharmacovigilance, Protocol, Biotechnology, eCTD, 21 CFR Part 11, ICH-GCP, Sop
Education
Hibernia College
M.Sc., Pharmaceutical Medicine (First Class Honours)
University of Michigan
Ph.D., Biological Anthropology
University of Michigan
A.M., Biological Anthropology
University of Michigan
A.B. (Honors and Highest Distinction), Anthropology
Yaroch Consulting, LLC 2015 - Present
Amgen 2011 - 2014
Amgen 2008 - 2011
Takeda Global Research and Development 2005 - 2008
Pfizer Global Research and Development 2003 - 2005
Pfizer Global Research and Development 2001 - 2003
Parke-Davis Pharmaceutical Research/Pfizer Global Research and Development 1999 - 2001
Parke-Davis Pharmaceutical Research, contractor through Terre Clinical Research 1998 - 1999
STATPROBE, Inc 1996 - 1998
Skills
Pharmaceutical Industry, Regulatory Submissions, NDA, Drug Development, Clinical Research, Clinical Study Design, Clinical Trials, Clinical Development, SAS, Neuroscience, Medical Writing, FDA, GCP, IND, Drug Metabolism, CTMS, Pharmacology, Regulatory Affairs, Data Management, CRO, Infectious Diseases, Diabetes, Therapeutic Areas, Biopharmaceuticals, Medical Affairs, Pharmacovigilance, Protocol, Biotechnology, eCTD, 21 CFR Part 11, ICH-GCP, Sop
Education
Hibernia College
M.Sc., Pharmaceutical Medicine (First Class Honours)
University of Michigan
Ph.D., Biological Anthropology
University of Michigan
A.M., Biological Anthropology
University of Michigan
A.B. (Honors and Highest Distinction), Anthropology
Meredith Sattler Miller Meredith Sattler Miller's Takeda Global Research and Development Experience October 2008 - Present
Job Senior Clinical Study Manager at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Global Research and Development October 2008 - Present
M3 Clinical Services, Inc. May 2000 - Present
Takeda Global Research and Development November 2007 - October 2008
BioSante Pharmaceuticals Inc February 2007 - November 2007
Takeda Global Research and Development September 2006 - February 2007
Takeda Global Research and Development July 2003 - September 2006
Takeda Global Reserach and Developement February 2003 - July 2003
Abbott Laboratories October 2002 - February 2003
Takeda Global Research and Development January 2002 - October 2002
TAP Pharmaceuticals August 2000 - January 2002
Education
Indiana University Bloomington 1991 — 1995
Bachelor of Science, Biology
Takeda Global Research and Development October 2008 - Present
M3 Clinical Services, Inc. May 2000 - Present
Takeda Global Research and Development November 2007 - October 2008
BioSante Pharmaceuticals Inc February 2007 - November 2007
Takeda Global Research and Development September 2006 - February 2007
Takeda Global Research and Development July 2003 - September 2006
Takeda Global Reserach and Developement February 2003 - July 2003
Abbott Laboratories October 2002 - February 2003
Takeda Global Research and Development January 2002 - October 2002
TAP Pharmaceuticals August 2000 - January 2002
Education
Indiana University Bloomington 1991 — 1995
Bachelor of Science, Biology
Roy Allen Roy Allen's Takeda Global Research and Development Experience October 2006 - February 2009
Job Senior Analytical Consultant at CVS Caremark
Industry Pharmaceuticals
Experience
CVS Caremark 2012 - Present
Takeda Pharmaceuticals North America October 2011 - January 2012
Takeda Pharmaceuticals North America February 2009 - October 2011
Takeda Global Research and Development October 2006 - February 2009
Delta Pharma January 2003 - October 2006
Fullerton Engineering Consultants, Inc. May 2000 - October 2002
Takeda Pharmaceuticals North America, Inc. November 1999 - May 2000
Bake-Line/Keebler, Inc., Des Plaines, IL March 1996 - November 1999
Skills
SAP, COGNOS, Peachtree, Lacerte Tax, QuickBooks, CODA, Microsoft Office, Accounting, Budgeting, Financial Planning, Auditing, Cash Flow, Invoicing, Audit, Forecasting, General Ledger, Financial Analysis, Variance Analysis, Financial Reporting, PowerPoint, Word, Excel, Process Improvement, Financial Accounting, Compliance, Strategic Financial..., Budgets, Strategy, Internal Audit, Leadership, Internal Controls, Pharmaceutical Industry, Access, Accounts Payable, Microsoft Word, Cognos, Business Process, Vendor Management, Start-ups, Microsoft Excel, Accounts Receivable, Finance, Analysis, Data Analysis, Coda, Project Planning, Management, Project Management
Education
North Park University 2009 — 2012
Pursuing, Business Admin/Mgmt, Sophmore-Junior
CVS Caremark 2012 - Present
Takeda Pharmaceuticals North America October 2011 - January 2012
Takeda Pharmaceuticals North America February 2009 - October 2011
Takeda Global Research and Development October 2006 - February 2009
Delta Pharma January 2003 - October 2006
Fullerton Engineering Consultants, Inc. May 2000 - October 2002
Takeda Pharmaceuticals North America, Inc. November 1999 - May 2000
Bake-Line/Keebler, Inc., Des Plaines, IL March 1996 - November 1999
Skills
SAP, COGNOS, Peachtree, Lacerte Tax, QuickBooks, CODA, Microsoft Office, Accounting, Budgeting, Financial Planning, Auditing, Cash Flow, Invoicing, Audit, Forecasting, General Ledger, Financial Analysis, Variance Analysis, Financial Reporting, PowerPoint, Word, Excel, Process Improvement, Financial Accounting, Compliance, Strategic Financial..., Budgets, Strategy, Internal Audit, Leadership, Internal Controls, Pharmaceutical Industry, Access, Accounts Payable, Microsoft Word, Cognos, Business Process, Vendor Management, Start-ups, Microsoft Excel, Accounts Receivable, Finance, Analysis, Data Analysis, Coda, Project Planning, Management, Project Management
Education
North Park University 2009 — 2012
Pursuing, Business Admin/Mgmt, Sophmore-Junior
Pete Vonier Pete Vonier's Takeda Global Research and Development Experience 2008 - November 2008
Job Owner and CRA Consultant, Vonier Research Consulting, LLC
Industry Pharmaceuticals
Experience
Cmed Clinical Services February 2011 - Present
OWL Oncology Research, LLC July 2010 - Present
Vonier Research Consulting, LLC November 2008 - Present
Quintiles, Novella, and PharmaLink 2008 - Present
Catalyst 2014 - 2015
Veristat, Inc. June 2011 - August 2011
Takeda Global Research and Development 2008 - November 2008
TAP Pharmaceutical Products 2004 - November 2008
Target Research Associates 2002 - 2004
Skills
Auditing, EDC, Oncology Clinical..., Clinical Research, Clinical Monitoring, CRO, GCP, Clinical Development, CTMS, Therapeutic Areas, Oncology, Infectious Diseases, Clinical Data Management, Clinical Trials, Sop, ICH-GCP, Clinical Operations, Regulatory Submissions, Protocol, Regulatory Affairs, Drug Development, Medical Writing, Clinical Research..., Pharmaceutical Industry, Phase I, Neurology, Pharmacovigilance, Vaccines, Endocrinology, Oracle Clinical
Education
Tulane University 1994 — 1998
PhD, Biology
University of Arizona 1988 — 1993
BS, Molecular and Cellulary Biology
Cmed Clinical Services February 2011 - Present
OWL Oncology Research, LLC July 2010 - Present
Vonier Research Consulting, LLC November 2008 - Present
Quintiles, Novella, and PharmaLink 2008 - Present
Catalyst 2014 - 2015
Veristat, Inc. June 2011 - August 2011
Takeda Global Research and Development 2008 - November 2008
TAP Pharmaceutical Products 2004 - November 2008
Target Research Associates 2002 - 2004
Skills
Auditing, EDC, Oncology Clinical..., Clinical Research, Clinical Monitoring, CRO, GCP, Clinical Development, CTMS, Therapeutic Areas, Oncology, Infectious Diseases, Clinical Data Management, Clinical Trials, Sop, ICH-GCP, Clinical Operations, Regulatory Submissions, Protocol, Regulatory Affairs, Drug Development, Medical Writing, Clinical Research..., Pharmaceutical Industry, Phase I, Neurology, Pharmacovigilance, Vaccines, Endocrinology, Oracle Clinical
Education
Tulane University 1994 — 1998
PhD, Biology
University of Arizona 1988 — 1993
BS, Molecular and Cellulary Biology
Joyce Heflin Joyce Heflin's Takeda Global Research and Development Experience June 2011 - July 2015
Job Global Submissions Project Manager, Regulatory Affairs at AbbVie
Industry Pharmaceuticals
Experience
AbbVie August 2015 - Present
Takeda Global Research and Development June 2011 - July 2015
Takeda Global Research and Development January 2007 - June 2011
Walgreens September 2005 - January 2007
Abbott Laboratories March 2003 - July 2005
Abbott Laboratories February 2001 - March 2003
Skills
Pharmaceutical Industry, Medical Writing, Quality Assurance, Document Management, Software Documentation, Sop, Protocol, Editing, Regulatory Submissions, Regulatory Documentation, Clinical Trials, Documentum, Adobe Acrobat, Microsoft Office, Training, SOP, Clinical Development, FDA, GCP
Education
Illinois State University 1992 — 1994
BS, English
AbbVie August 2015 - Present
Takeda Global Research and Development June 2011 - July 2015
Takeda Global Research and Development January 2007 - June 2011
Walgreens September 2005 - January 2007
Abbott Laboratories March 2003 - July 2005
Abbott Laboratories February 2001 - March 2003
Skills
Pharmaceutical Industry, Medical Writing, Quality Assurance, Document Management, Software Documentation, Sop, Protocol, Editing, Regulatory Submissions, Regulatory Documentation, Clinical Trials, Documentum, Adobe Acrobat, Microsoft Office, Training, SOP, Clinical Development, FDA, GCP
Education
Illinois State University 1992 — 1994
BS, English
Stephen M. Sainati Stephen M. Sainati's Takeda Global Research and Development Experience 2002 - 2009
Job Principal Owner at Orso Consulting LLC
Industry Pharmaceuticals
Experience
Orso Consulting LLC August 2013 - Present
Takeda Pharmaceuticals International, Inc. January 2010 - July 2013
Takeda Global Research and Development 2002 - 2009
Pharmacia Corporation (now Pfizer) April 1995 - January 2002
Searle 1996 - 1998
Hoechst-Roussel Pharmaceuticals, Inc. 1986 - 1994
Skills
Clinical Pharmacology, Behavioral Neuroscience, Pharmaceutical Industry, Clinical Development, Clinical Research, Drug Development, Clinical Trials, Psychiatry, Medical Affairs, Therapeutic Areas, Translational Medicine, Neuroscience, Pharmacology, Regulatory Affairs, Medicine, Internal Medicine, Diabetes, CTMS, Oncology, IND, Rheumatology, Clinical Study Design
Education
Loyola University Chicago Stritch School of Medicine 1983 — 1985
MD, Internal Medicine
Loyola University Chicago 1975 — 1982
PhD, Pharmacology, Neuroscience
University of Illinois at Chicago 1974 — 1975
MS, Biochemistry
Vanderbilt University 1970 — 1974
BA, Biology, Chemistry, Mathematics
Orso Consulting LLC August 2013 - Present
Takeda Pharmaceuticals International, Inc. January 2010 - July 2013
Takeda Global Research and Development 2002 - 2009
Pharmacia Corporation (now Pfizer) April 1995 - January 2002
Searle 1996 - 1998
Hoechst-Roussel Pharmaceuticals, Inc. 1986 - 1994
Skills
Clinical Pharmacology, Behavioral Neuroscience, Pharmaceutical Industry, Clinical Development, Clinical Research, Drug Development, Clinical Trials, Psychiatry, Medical Affairs, Therapeutic Areas, Translational Medicine, Neuroscience, Pharmacology, Regulatory Affairs, Medicine, Internal Medicine, Diabetes, CTMS, Oncology, IND, Rheumatology, Clinical Study Design
Education
Loyola University Chicago Stritch School of Medicine 1983 — 1985
MD, Internal Medicine
Loyola University Chicago 1975 — 1982
PhD, Pharmacology, Neuroscience
University of Illinois at Chicago 1974 — 1975
MS, Biochemistry
Vanderbilt University 1970 — 1974
BA, Biology, Chemistry, Mathematics
Amy P Hagaman Amy P Hagaman's Takeda Global Research and Development Experience 2001 - 2007
Job Global GXP Professional for Audit & Compliance Solutions
Industry Pharmaceuticals
Experience
Audit & Compliance Solutions July 2010 - Present
PPD April 2008 - July 2010
Takeda Global Research and Development 2001 - 2007
Searle,Pharmacia, Pfizer January 2000 - December 2001
PPD September 1997 - January 2000
Wake Forest Baptist Health March 1987 - May 1993
Skills
GxP Audits, Risk Management, Global Management, GLP, cGMP, Excel, PowerPoint, Access, Auditing, GxP, GCP, CRO, Clinical Trials, FDA, CTMS, Sop, EDC, Clinical Monitoring, Regulatory Affairs, Quality Assurance, Clinical Data Management, Pharmacovigilance, Clinical Research, CAPA, Therapeutic Areas, Protocol, Medical Devices, Computer System..., Clinical Operations, Quality Auditing, Data Management, IRB, Clinical Study Design, Cardiology, Diabetes, Process Improvement, Neurology, ICH-GCP, Clinical Development, Regulatory Submissions, 21 CFR Part 11, Training, Pharmaceutical Industry, NDA, Regulatory Requirements, Biostatistics, Drug Development, Vaccines, IND, Biotechnology
Education
Reed Institute of Interview and Interrogation 2003 — 2003
Certication, Comprehensive Interview/Interrogation Training
CS - Mediators and Conflict Management 1996 — 1996
Certification, Mediation and Conflict Management
Forsyth Technical Community College 1995 — 1996
Certification, IT Software & Computer Technology/Chemistry
North Carolina State University 1984 — 1986
BS, Psychology, Religion
University of North Carolina at Greensboro 1980 — 1981
Bachelors, Nursing/Psychology
Forsyth Technical Community College 1970 — 1971
Associates Degree, Nursing
Audit & Compliance Solutions July 2010 - Present
PPD April 2008 - July 2010
Takeda Global Research and Development 2001 - 2007
Searle,Pharmacia, Pfizer January 2000 - December 2001
PPD September 1997 - January 2000
Wake Forest Baptist Health March 1987 - May 1993
Skills
GxP Audits, Risk Management, Global Management, GLP, cGMP, Excel, PowerPoint, Access, Auditing, GxP, GCP, CRO, Clinical Trials, FDA, CTMS, Sop, EDC, Clinical Monitoring, Regulatory Affairs, Quality Assurance, Clinical Data Management, Pharmacovigilance, Clinical Research, CAPA, Therapeutic Areas, Protocol, Medical Devices, Computer System..., Clinical Operations, Quality Auditing, Data Management, IRB, Clinical Study Design, Cardiology, Diabetes, Process Improvement, Neurology, ICH-GCP, Clinical Development, Regulatory Submissions, 21 CFR Part 11, Training, Pharmaceutical Industry, NDA, Regulatory Requirements, Biostatistics, Drug Development, Vaccines, IND, Biotechnology
Education
Reed Institute of Interview and Interrogation 2003 — 2003
Certication, Comprehensive Interview/Interrogation Training
CS - Mediators and Conflict Management 1996 — 1996
Certification, Mediation and Conflict Management
Forsyth Technical Community College 1995 — 1996
Certification, IT Software & Computer Technology/Chemistry
North Carolina State University 1984 — 1986
BS, Psychology, Religion
University of North Carolina at Greensboro 1980 — 1981
Bachelors, Nursing/Psychology
Forsyth Technical Community College 1970 — 1971
Associates Degree, Nursing
Mitchell Friedman, PhD DABT's Takeda Global Research and Development Experience 2007 - April 2013
Job Sr. Director of Toxicology at Takeda Drug Safety Research Laboratories, Deerfield
Industry Pharmaceuticals
Experience
Takeda Drug Safety Research Laboratories, Deerfield April 2013 - Present
Takeda Global Research and Development 2007 - April 2013
deCODE Genetics May 2006 - January 2007
Ligand Pharmaceuticals 2006 - 2007
Sepracor October 2003 - January 2004
Abbott Laboratories September 1980 - October 2003
Skills
Clinical Development, Toxicology, IND, CRO, Clinical Pharmacology, Immunology, GMP, Drug Discovery, Oncology, Translational Medicine, Drug Metabolism, Science, Infectious Diseases, FDA, Drug Development, GCP, Lifesciences, Biotechnology, Pharmaceutical Industry, Drug Safety, Pharmaceutics, Pharmacology, R&D, GLP, Regulatory Submissions, Bioanalysis, Validation, Regulatory Affairs, Biomarkers, Pharmacokinetics, Staff Mentor, In Vivo, Clinical Trials, Biopharmaceuticals, In Vitro, Therapeutic Areas, Sop, Formulation, Assay Development, DMPK, ADME, Vaccines, HPLC, Technology Transfer, Clinical Study Design, Pharmacovigilance, Neuroscience, Animal Models, Cell, Protocol
Education
The University of Texas at Austin 1976 — 1979
Doctor of Philosophy (PhD), Pharmacology and Toxicology
Takeda Drug Safety Research Laboratories, Deerfield April 2013 - Present
Takeda Global Research and Development 2007 - April 2013
deCODE Genetics May 2006 - January 2007
Ligand Pharmaceuticals 2006 - 2007
Sepracor October 2003 - January 2004
Abbott Laboratories September 1980 - October 2003
Skills
Clinical Development, Toxicology, IND, CRO, Clinical Pharmacology, Immunology, GMP, Drug Discovery, Oncology, Translational Medicine, Drug Metabolism, Science, Infectious Diseases, FDA, Drug Development, GCP, Lifesciences, Biotechnology, Pharmaceutical Industry, Drug Safety, Pharmaceutics, Pharmacology, R&D, GLP, Regulatory Submissions, Bioanalysis, Validation, Regulatory Affairs, Biomarkers, Pharmacokinetics, Staff Mentor, In Vivo, Clinical Trials, Biopharmaceuticals, In Vitro, Therapeutic Areas, Sop, Formulation, Assay Development, DMPK, ADME, Vaccines, HPLC, Technology Transfer, Clinical Study Design, Pharmacovigilance, Neuroscience, Animal Models, Cell, Protocol
Education
The University of Texas at Austin 1976 — 1979
Doctor of Philosophy (PhD), Pharmacology and Toxicology
Patrick Cullinan's Takeda Global Research and Development Experience August 2006 - August 2013
Job Director Global Clinical Transparency at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals August 2014 - Present
Takeda Pharmaceuticals - Takeda Development Center Americas September 2013 - July 2014
Takeda Global Research and Development August 2006 - August 2013
Skills
Medical Writing, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Trials, GCP, Therapeutic Areas, Immunology
Education
University of Chicago - The Pritzker School of Medicine
University College Dublin
Takeda Pharmaceuticals August 2014 - Present
Takeda Pharmaceuticals - Takeda Development Center Americas September 2013 - July 2014
Takeda Global Research and Development August 2006 - August 2013
Skills
Medical Writing, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Trials, GCP, Therapeutic Areas, Immunology
Education
University of Chicago - The Pritzker School of Medicine
University College Dublin
Daniel Selness's Takeda Global Research and Development Experience 2005 - April 2007
Job Chief Strategy Officer at Spaulding Clinical Research, LLC
Industry Pharmaceuticals
Experience
Spaulding Clinical Research, LLC January 2015 - Present
Spaulding Clinical Research, LLC April 2012 - January 2015
Spaulding Clinical Research, LLC 2010 - 2012
Spaulding Clinical Research, LLC 2008 - 2010
Takeda Global Research & Development Center 2007 - 2008
Takeda Global Research and Development 2005 - April 2007
Takeda Pharmaceuticals 2003 - 2005
Abbott Laboratories 1993 - 2003
US Navy 1989 - 1993
Skills
Clinical Development, Clinical Trials, Clinical Research, CRO, Pharmaceutical Industry, Oncology, GCP, CTMS, Biotechnology, FDA, Medical Devices, Clinical Operations, R&D, Sop, Cardiology, Drug Discovery, Lifesciences, EDC, Validation, Regulatory Submissions, Immunology, GLP, Therapeutic Areas, Diabetes, Data Management, Pharmacovigilance, Healthcare, Biopharmaceuticals, Vaccines, Regulatory Affairs, Infectious Diseases, Clinical Pharmacology, Neurology, Protocol, Regulatory Requirements, Drug Development, Clinical Monitoring, Quality Assurance, ICH-GCP, GMP, Pharmaceutics, Dermatology, Clinical Data Management, Pharmacology, Hematology, Medical Writing, 21 CFR Part 11, Cross-functional Team..., Management, Phase I
Education
Cardinal Stritch University 1999 — 2002
MBA, Business Management
Concordia University-Wisconsin 1999 — 2002
BA, Healthcare Administration
Gateway Technical College 1993 — 1996
ADN, Registered Nursing
Spaulding Clinical Research, LLC January 2015 - Present
Spaulding Clinical Research, LLC April 2012 - January 2015
Spaulding Clinical Research, LLC 2010 - 2012
Spaulding Clinical Research, LLC 2008 - 2010
Takeda Global Research & Development Center 2007 - 2008
Takeda Global Research and Development 2005 - April 2007
Takeda Pharmaceuticals 2003 - 2005
Abbott Laboratories 1993 - 2003
US Navy 1989 - 1993
Skills
Clinical Development, Clinical Trials, Clinical Research, CRO, Pharmaceutical Industry, Oncology, GCP, CTMS, Biotechnology, FDA, Medical Devices, Clinical Operations, R&D, Sop, Cardiology, Drug Discovery, Lifesciences, EDC, Validation, Regulatory Submissions, Immunology, GLP, Therapeutic Areas, Diabetes, Data Management, Pharmacovigilance, Healthcare, Biopharmaceuticals, Vaccines, Regulatory Affairs, Infectious Diseases, Clinical Pharmacology, Neurology, Protocol, Regulatory Requirements, Drug Development, Clinical Monitoring, Quality Assurance, ICH-GCP, GMP, Pharmaceutics, Dermatology, Clinical Data Management, Pharmacology, Hematology, Medical Writing, 21 CFR Part 11, Cross-functional Team..., Management, Phase I
Education
Cardinal Stritch University 1999 — 2002
MBA, Business Management
Concordia University-Wisconsin 1999 — 2002
BA, Healthcare Administration
Gateway Technical College 1993 — 1996
ADN, Registered Nursing
Hiran Shah, PMP's Takeda Global Research and Development Experience September 2009 - March 2011
Job Product Manager at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals January 2012 - Present
Takeda Pharmaceuticals March 2011 - February 2012
Takeda Global Research and Development September 2009 - March 2011
Takeda Pharmaceutical North America June 2008 - August 2009
TAP Pharmaceuticals October 2005 - June 2008
TAP Pharmaceuticals January 2004 - October 2005
Skills
Software Project..., Product Management, Global Projects, Projects, Requirements Gathering, Data Warehousing, Business Analysis, Project Management, Cross-functional Team..., Process Improvement, SDLC, Visio, Vendor Management, Business Intelligence, IT Strategy, Business Process..., Disaster Recovery, IT Management, Pharmaceutical Industry, PMP, Project Portfolio..., Software Documentation, MS Project, Quality Assurance, Integration, ITIL, Business Process, Change Control, Change Management, PMO, Product Launch, Resource Management, Analysis, FDA
Education
DePaul University 2005 — 2009
M.S in Business Information Technology, Management, Marketing, Information Security, Database Design, Supply Chain, Web Development
Northeastern Illinois University 1996 — 2002
B.S. in Business Management, Business Management
Takeda Pharmaceuticals January 2012 - Present
Takeda Pharmaceuticals March 2011 - February 2012
Takeda Global Research and Development September 2009 - March 2011
Takeda Pharmaceutical North America June 2008 - August 2009
TAP Pharmaceuticals October 2005 - June 2008
TAP Pharmaceuticals January 2004 - October 2005
Skills
Software Project..., Product Management, Global Projects, Projects, Requirements Gathering, Data Warehousing, Business Analysis, Project Management, Cross-functional Team..., Process Improvement, SDLC, Visio, Vendor Management, Business Intelligence, IT Strategy, Business Process..., Disaster Recovery, IT Management, Pharmaceutical Industry, PMP, Project Portfolio..., Software Documentation, MS Project, Quality Assurance, Integration, ITIL, Business Process, Change Control, Change Management, PMO, Product Launch, Resource Management, Analysis, FDA
Education
DePaul University 2005 — 2009
M.S in Business Information Technology, Management, Marketing, Information Security, Database Design, Supply Chain, Web Development
Northeastern Illinois University 1996 — 2002
B.S. in Business Management, Business Management
Ines Lauva's Takeda Global Research and Development Experience 2001 - Present
Job Sr. Project Manager at TGRD
Industry Pharmaceuticals
Experience
TGRD October 2001 - Present
Takeda Global Research and Development 2001 - Present
Takeda Pharmacueticals 2001 - Present
Takeda Global R&D 2001 - Present
Takeda Pharmaceuticals 2001 - Present
Skills
Clinical Trials, CTMS, Biotechnology, GCP, Medical Writing, FDA, Clinical Development, GMP, Clinical Research, ICH-GCP, Regulatory Affairs, Drug Development, Infectious Diseases, Therapeutic Areas, Oncology, EDC, Pharmaceutical Industry, Lifesciences, Quality Assurance, Pharmacovigilance, Regulatory Submissions, Sop, CRO, Clinical Monitoring, Medical Affairs, Clinical Data Management, 21 CFR Part 11, IND, Clinical Study Design, Clinical Operations, Vaccines, Immunology, Diabetes, Endocrinology, Biopharmaceuticals, Regulatory Requirements
Education
University of Iowa
TGRD October 2001 - Present
Takeda Global Research and Development 2001 - Present
Takeda Pharmacueticals 2001 - Present
Takeda Global R&D 2001 - Present
Takeda Pharmaceuticals 2001 - Present
Skills
Clinical Trials, CTMS, Biotechnology, GCP, Medical Writing, FDA, Clinical Development, GMP, Clinical Research, ICH-GCP, Regulatory Affairs, Drug Development, Infectious Diseases, Therapeutic Areas, Oncology, EDC, Pharmaceutical Industry, Lifesciences, Quality Assurance, Pharmacovigilance, Regulatory Submissions, Sop, CRO, Clinical Monitoring, Medical Affairs, Clinical Data Management, 21 CFR Part 11, IND, Clinical Study Design, Clinical Operations, Vaccines, Immunology, Diabetes, Endocrinology, Biopharmaceuticals, Regulatory Requirements
Education
University of Iowa
Dr Julie (Dr J) Robinson's Takeda Global Research and Development Experience July 2008 - August 2012
Job Senior Manager Vendor Management Global Compound Support Quality Assurance at Takeda Pharmaceuticals International, INc.
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals International Inc. October 2013 - Present
Takeda Development Center, Americas August 2012 - October 2013
Takeda Global Research and Development July 2008 - August 2012
Takeda Pharmaceuticals Inc. 2008 - July 2008
TAP Pharmaceutical Products, Inc. March 2001 - June 2008
Skills
SOP, FDA, Regulatory Affairs, GCP, GLP, Veterinary, Sop, 21 CFR Part 11, Clinical Trials, Drug Discovery, Clinical Research, Quality Assurance, Pharmaceutical Industry, Quality Auditing, GxP, Documentum, CRO, CTMS, Regulatory Submissions, Drug Development, CAPA, Validation, Pharmacovigilance, Clinical Development, Change Control, EDC
Education
Purdue University 2011 — 2012
Graduate Certificate Program, Regulatory and Quality Compliance, A
University of Missouri-Columbia 1978 — 1992
BS, DVM, MS, Animal Science, Veterinary Medicine, Veterinary Microbiology
University of Pennsylvania New Bolton Center 1989 — 1990
Fellowship, Large Animal Internal Medicine
Western College of Veterinary Medicine University of Saskatchewan 1987 — 1989
Residency, Large Animal Internal Medicine
Western College of Veterinary Medicine, University of Saskatchewan 1987 — 1989
MVSc, Large Animal Internal Medicine
North Carolina State University 1986 — 1987
Internship, Equine Field Service
Takeda Pharmaceuticals International Inc. October 2013 - Present
Takeda Development Center, Americas August 2012 - October 2013
Takeda Global Research and Development July 2008 - August 2012
Takeda Pharmaceuticals Inc. 2008 - July 2008
TAP Pharmaceutical Products, Inc. March 2001 - June 2008
Skills
SOP, FDA, Regulatory Affairs, GCP, GLP, Veterinary, Sop, 21 CFR Part 11, Clinical Trials, Drug Discovery, Clinical Research, Quality Assurance, Pharmaceutical Industry, Quality Auditing, GxP, Documentum, CRO, CTMS, Regulatory Submissions, Drug Development, CAPA, Validation, Pharmacovigilance, Clinical Development, Change Control, EDC
Education
Purdue University 2011 — 2012
Graduate Certificate Program, Regulatory and Quality Compliance, A
University of Missouri-Columbia 1978 — 1992
BS, DVM, MS, Animal Science, Veterinary Medicine, Veterinary Microbiology
University of Pennsylvania New Bolton Center 1989 — 1990
Fellowship, Large Animal Internal Medicine
Western College of Veterinary Medicine University of Saskatchewan 1987 — 1989
Residency, Large Animal Internal Medicine
Western College of Veterinary Medicine, University of Saskatchewan 1987 — 1989
MVSc, Large Animal Internal Medicine
North Carolina State University 1986 — 1987
Internship, Equine Field Service
Kathyrn Albrecht's Takeda Global Research and Development Experience October 2004 - July 2013
Job GCP Audit Contractor at Aerotek
Industry Pharmaceuticals
Experience
Aerotek October 2013 - Present
Takeda Global Research and Development October 2004 - July 2013
Abbott Laboratories 1988 - 2004
Skills
Regulatory Affairs, GxP, Regulatory Submissions, CAPA, 21 CFR Part 11, Sop, GLP, GCP, Validation, Pharmaceutical Industry, Clinical Development, Clinical Trials, CTMS, FDA, Medical Devices, Change Control, Drug Development, CRO, Computer System..., Pharmacovigilance, Regulatory Requirements, EDC, Oncology, GMP, Biopharmaceuticals, Technology Transfer, Biotechnology, Quality System, Clinical Data Management, Protocol, Quality Auditing, Lifesciences, Pharmaceutics, SOP
Education
Keller Graduate School of Management of DeVry University 2009 — 2012
Masters of Business Administration, Project Management
University of Wisconsin-Stevens Point 1976 — 1980
B.S., Biology
Aerotek October 2013 - Present
Takeda Global Research and Development October 2004 - July 2013
Abbott Laboratories 1988 - 2004
Skills
Regulatory Affairs, GxP, Regulatory Submissions, CAPA, 21 CFR Part 11, Sop, GLP, GCP, Validation, Pharmaceutical Industry, Clinical Development, Clinical Trials, CTMS, FDA, Medical Devices, Change Control, Drug Development, CRO, Computer System..., Pharmacovigilance, Regulatory Requirements, EDC, Oncology, GMP, Biopharmaceuticals, Technology Transfer, Biotechnology, Quality System, Clinical Data Management, Protocol, Quality Auditing, Lifesciences, Pharmaceutics, SOP
Education
Keller Graduate School of Management of DeVry University 2009 — 2012
Masters of Business Administration, Project Management
University of Wisconsin-Stevens Point 1976 — 1980
B.S., Biology
Greg Murawski's Takeda Global Research and Development Experience May 2008 - Present
Job Associate Director, Regulatory Affairs, Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Global Research and Development May 2008 - Present
TAP Pharmaceutical Products July 2006 - May 2008
Abbott Laboratories May 2005 - June 2006
Abbott Laboratories April 2002 - May 2005
Abbott Diagnostics Division International November 2000 - April 2002
Abbott Diagnostics Division International September 1996 - November 2000
Abbott Diagnostics Division May 1994 - September 1996
Abbott Diagnostics Division May 1993 - May 1994
Abbott Diagnostics Division March 1992 - May 1993
Abbott Diagnostics Division September 1991 - March 1992
Education
Loyola University Chicago School of Law 2004 — 2006
Master of Jurisprudence, Health Law
Roosevelt University 2000 — 2002
M.B.A., International Business
University of West Florida 1980 — 1983
B.S., Science
Thornton Community College 1979 — 1980
A.S., Chemistry
Takeda Global Research and Development May 2008 - Present
TAP Pharmaceutical Products July 2006 - May 2008
Abbott Laboratories May 2005 - June 2006
Abbott Laboratories April 2002 - May 2005
Abbott Diagnostics Division International November 2000 - April 2002
Abbott Diagnostics Division International September 1996 - November 2000
Abbott Diagnostics Division May 1994 - September 1996
Abbott Diagnostics Division May 1993 - May 1994
Abbott Diagnostics Division March 1992 - May 1993
Abbott Diagnostics Division September 1991 - March 1992
Education
Loyola University Chicago School of Law 2004 — 2006
Master of Jurisprudence, Health Law
Roosevelt University 2000 — 2002
M.B.A., International Business
University of West Florida 1980 — 1983
B.S., Science
Thornton Community College 1979 — 1980
A.S., Chemistry
Greer Chambers, CPM's Takeda Global Research and Development Experience November 2008 - March 2012
Job Project Director at Covance
Industry Pharmaceuticals
Experience
Covance September 2014 - Present
Covance April 2012 - September 2014
Takeda Global Research and Development November 2008 - March 2012
Takeda Global Research & Development October 2003 - November 2008
Takeda Global R&D Europe January 2007 - July 2007
Advanced Clinical Associates November 2002 - October 2003
SCIREX Corp. December 2001 - November 2002
Pharmacia (Searle) January 2000 - October 2002
Respiratory Clinical Research Program, U of Chicago April 1999 - January 2000
Skills
GCP, CTMS, Clinical Monitoring, EDC, Clinical Research, CRO, Clinical Trials, Infectious Diseases, Endocrinology, Clinical Development, Rheumatology, Therapeutic Areas, Diabetes, Cardiology, Gastroenterology, Pharmaceutical Industry, Clinical Operations, Patient Recruitment, ICH-GCP, Protocol, Sop, Regulatory Submissions
Education
Indiana State University 1996 — 1998
BS, Life Science and Chemistry
Covance September 2014 - Present
Covance April 2012 - September 2014
Takeda Global Research and Development November 2008 - March 2012
Takeda Global Research & Development October 2003 - November 2008
Takeda Global R&D Europe January 2007 - July 2007
Advanced Clinical Associates November 2002 - October 2003
SCIREX Corp. December 2001 - November 2002
Pharmacia (Searle) January 2000 - October 2002
Respiratory Clinical Research Program, U of Chicago April 1999 - January 2000
Skills
GCP, CTMS, Clinical Monitoring, EDC, Clinical Research, CRO, Clinical Trials, Infectious Diseases, Endocrinology, Clinical Development, Rheumatology, Therapeutic Areas, Diabetes, Cardiology, Gastroenterology, Pharmaceutical Industry, Clinical Operations, Patient Recruitment, ICH-GCP, Protocol, Sop, Regulatory Submissions
Education
Indiana State University 1996 — 1998
BS, Life Science and Chemistry
Karen L. Gilbert, BS, CCRA's Takeda Global Research and Development Experience 2008 - 2011
Job Clinical Research Consultant at Root Cause Research Consulting, LLC
Industry Pharmaceuticals
Experience
Root Cause Research Consulting, LLC September 2014 - Present
Covance September 2013 - August 2014
Barnett Educational Services 2011 - September 2013
Takeda Global Research & Development Center, Inc 2010 - 2011
Takeda Global Research and Development 2008 - 2011
Takeda Pharmaceuticals 2008 - 2011
Takeda Global Research & Development Center, Inc January 2007 - 2011
TAP Pharmaceutical Products Inc. 2007 - 2008
TAP Pharmaceuticals 2007 - 2008
TAP Pharmaceuticals May 2005 - January 2007
Skills
Clinical Monitoring, EDC, GCP, CTMS, Clinical Trials, CRO, Oncology, Clinical Development, Clinical Research, Pharmaceutical Industry, ICH-GCP, Sop, Endocrinology, Rheumatology, Cardiology
Education
Johns Hopkins School of Medicine 1987 — 1988
in M.D./Ph.D. program, Human
University of South Carolina 1982 — 1986
B.S, Biology
University of South Carolina-Columbia 1982 — 1986
B.S., Biology and Chemistry
Root Cause Research Consulting, LLC September 2014 - Present
Covance September 2013 - August 2014
Barnett Educational Services 2011 - September 2013
Takeda Global Research & Development Center, Inc 2010 - 2011
Takeda Global Research and Development 2008 - 2011
Takeda Pharmaceuticals 2008 - 2011
Takeda Global Research & Development Center, Inc January 2007 - 2011
TAP Pharmaceutical Products Inc. 2007 - 2008
TAP Pharmaceuticals 2007 - 2008
TAP Pharmaceuticals May 2005 - January 2007
Skills
Clinical Monitoring, EDC, GCP, CTMS, Clinical Trials, CRO, Oncology, Clinical Development, Clinical Research, Pharmaceutical Industry, ICH-GCP, Sop, Endocrinology, Rheumatology, Cardiology
Education
Johns Hopkins School of Medicine 1987 — 1988
in M.D./Ph.D. program, Human
University of South Carolina 1982 — 1986
B.S, Biology
University of South Carolina-Columbia 1982 — 1986
B.S., Biology and Chemistry
Deborah DeManno's Takeda Global Research and Development Experience November 2011 - January 2013
Job Scientific Director, Global Translational Medicine at Takeda Pharmaceuticals International
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals International October 2014 - Present
Takeda Pharmaceuticals International March 2014 - Present
Takeda Phamaceuticals International August 2013 - Present
Takeda Development Center Americas, Inc. January 2013 - August 2013
Takeda Global Research and Development November 2011 - January 2013
Takeda Global Research and Development July 2008 - November 2011
TAP Pharmaceuticals December 1999 - July 2008
Abbott Laboratories 1994 - 1999
Northwestern University Medical School 1987 - 1994
Skills
Pharmacology, Drug Development, Pharmaceutical Industry, Diabetes, Translational Medicine
Education
Michigan Technological University
BS, Biology
University of Notre Dame
PhD, Biology
Takeda Pharmaceuticals International October 2014 - Present
Takeda Pharmaceuticals International March 2014 - Present
Takeda Phamaceuticals International August 2013 - Present
Takeda Development Center Americas, Inc. January 2013 - August 2013
Takeda Global Research and Development November 2011 - January 2013
Takeda Global Research and Development July 2008 - November 2011
TAP Pharmaceuticals December 1999 - July 2008
Abbott Laboratories 1994 - 1999
Northwestern University Medical School 1987 - 1994
Skills
Pharmacology, Drug Development, Pharmaceutical Industry, Diabetes, Translational Medicine
Education
Michigan Technological University
BS, Biology
University of Notre Dame
PhD, Biology
Karen Zylberman's Takeda Global Research and Development Experience October 2005 - November 2009
Job Director, Project Planning and Management at Takeda Research and Developement
Industry Pharmaceuticals
Experience
Takeda Global Research & Development Center, Inc. 2005 - Present
Takeda Global Research and Development October 2005 - November 2009
Skills
Pharmaceutical Industry, Clinical Trials, Oncology, GCP, Clinical Development, FDA, Quality Assurance, Regulatory Submissions, Regulatory Affairs, 21 CFR Part 11, Drug Development, Therapeutic Areas, CTMS, Biotechnology, CRO
Education
University of Illinois at Chicago 1975 — 1980
Takeda Global Research & Development Center, Inc. 2005 - Present
Takeda Global Research and Development October 2005 - November 2009
Skills
Pharmaceutical Industry, Clinical Trials, Oncology, GCP, Clinical Development, FDA, Quality Assurance, Regulatory Submissions, Regulatory Affairs, 21 CFR Part 11, Drug Development, Therapeutic Areas, CTMS, Biotechnology, CRO
Education
University of Illinois at Chicago 1975 — 1980
Sharon Kuhn's Takeda Global Research and Development Experience July 2008 - Present
Job Sr. CMC/GMP Compliance Coordinator at TAP Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Global Research and Development July 2008 - Present
TAP Pharmaceutical Products Inc 1998 - 2008
Abbott Laboratories 1980 - 1988
Education
Knox College 1972 — 1976
Bachelor of Arts (B.A.), Chemistry and Psychology
Takeda Global Research and Development July 2008 - Present
TAP Pharmaceutical Products Inc 1998 - 2008
Abbott Laboratories 1980 - 1988
Education
Knox College 1972 — 1976
Bachelor of Arts (B.A.), Chemistry and Psychology
Nancianne Knipfer's Takeda Global Research and Development Experience 2008 - Present
Job Manager, Regulatory Affairs Strategy
Industry Pharmaceuticals
Experience
Takeda Global Research and Development 2008 - Present
Education
Albert Einstein College of Medicine of Yeshiva University 1994 — 1998
Ph.D., Biochemistry
Eastern Illinois University 1990 — 1994
Takeda Global Research and Development 2008 - Present
Education
Albert Einstein College of Medicine of Yeshiva University 1994 — 1998
Ph.D., Biochemistry
Eastern Illinois University 1990 — 1994
Haiyan Grady's Takeda Global Research and Development Experience 2008 - Present
Job Research Fellow at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals July 2008 - Present
Takeda Global Research and Development 2008 - Present
Education
Iowa State University 1986 — 1991
Ph.D, Chemistry
Takeda Pharmaceuticals July 2008 - Present
Takeda Global Research and Development 2008 - Present
Education
Iowa State University 1986 — 1991
Ph.D, Chemistry
Dale Brinker's Takeda Global Research and Development Experience August 2008 - December 2009
Job Director, Technology Operations at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals, USA (TPUSA) May 2009 - Present
Takeda Global Research and Development August 2008 - December 2009
TAP Pharmaceutical Products Inc. September 2006 - August 2008
Skills
Pharmaceutical Industry, Technology Transfer, Validation, GMP, Process Improvement, Strategy, CMC, FDA, Regulatory Affairs, Drug Development, IND, Cross-functional Team..., Change Control, Oncology, CAPA, Dissolution, Clinical Development, eCTD, 21 CFR Part 11, Sop, GCP, Regulatory Submissions, Formulation, Analytical Chemistry, CRO, GLP, Biopharmaceuticals, V&V, Pharmaceutics, GxP, Regulatory Requirements
Education
University of Illinois at Chicago 1980 — 1983
BS, Pharmacy
Carthage College 1977 — 1980
None, Chemistry
Takeda Pharmaceuticals, USA (TPUSA) May 2009 - Present
Takeda Global Research and Development August 2008 - December 2009
TAP Pharmaceutical Products Inc. September 2006 - August 2008
Skills
Pharmaceutical Industry, Technology Transfer, Validation, GMP, Process Improvement, Strategy, CMC, FDA, Regulatory Affairs, Drug Development, IND, Cross-functional Team..., Change Control, Oncology, CAPA, Dissolution, Clinical Development, eCTD, 21 CFR Part 11, Sop, GCP, Regulatory Submissions, Formulation, Analytical Chemistry, CRO, GLP, Biopharmaceuticals, V&V, Pharmaceutics, GxP, Regulatory Requirements
Education
University of Illinois at Chicago 1980 — 1983
BS, Pharmacy
Carthage College 1977 — 1980
None, Chemistry
Sean Deck, PMP's Takeda Global Research and Development Experience August 2010 - December 2014
Job Director, GMO Project Management Office (PMO) at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals January 2015 - Present
Takeda Global Research and Development August 2010 - December 2014
Takeda Global Research and Development 2008 - August 2010
Takeda Global Research & Development May 2007 - May 2008
TAP Pharmaceutical Products Inc. September 2005 - May 2007
TAP Pharmaceutical Products Inc. August 2003 - September 2005
TAP Pharmaceutical Products Inc. May 2002 - August 2003
TAP Pharmaceutical Products Inc. August 2001 - May 2002
Skills
EDC, Database Management, Oracle Clinical, Data Management, Validation, Research Project..., Process, Process Improvement, Business Process..., Work Process Improvement, Implementing Processes, Implementing Training..., International Project..., Process Development, Process Management, Project Implementation, Training & Development, Process Mapping, Visio, MS Project, Process Optimization, Standardization, Standards Development, Standards Compliance, SOP, Compliance, Compliance Management, Globalization, Global Business..., Global Strategy, Business Strategy, Strategy Development, Strategy, Project Management, Clinical Data Management, Sop, Clinical Study Design, Clinical Research, Cross-functional Team...
Education
Lake Forest Graduate School of Management 2012 — 2016
MBA, Global Business
Purdue University 1997 — 2000
B.S., Management, MIS and Human Resources minor
Takeda Pharmaceuticals January 2015 - Present
Takeda Global Research and Development August 2010 - December 2014
Takeda Global Research and Development 2008 - August 2010
Takeda Global Research & Development May 2007 - May 2008
TAP Pharmaceutical Products Inc. September 2005 - May 2007
TAP Pharmaceutical Products Inc. August 2003 - September 2005
TAP Pharmaceutical Products Inc. May 2002 - August 2003
TAP Pharmaceutical Products Inc. August 2001 - May 2002
Skills
EDC, Database Management, Oracle Clinical, Data Management, Validation, Research Project..., Process, Process Improvement, Business Process..., Work Process Improvement, Implementing Processes, Implementing Training..., International Project..., Process Development, Process Management, Project Implementation, Training & Development, Process Mapping, Visio, MS Project, Process Optimization, Standardization, Standards Development, Standards Compliance, SOP, Compliance, Compliance Management, Globalization, Global Business..., Global Strategy, Business Strategy, Strategy Development, Strategy, Project Management, Clinical Data Management, Sop, Clinical Study Design, Clinical Research, Cross-functional Team...
Education
Lake Forest Graduate School of Management 2012 — 2016
MBA, Global Business
Purdue University 1997 — 2000
B.S., Management, MIS and Human Resources minor
Sandra Cosner's Takeda Global Research and Development Experience October 2008 - February 2011
Job Regulatory Affairs Strategy
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals March 2011 - Present
Takeda Global Research and Development October 2008 - February 2011
Takeda Global Research and Development October 2005 - September 2008
Abbott Laboratories October 2003 - September 2005
Abbott Laboratories December 2001 - October 2003
Abbott Laboratories August 1999 - December 2001
Abbott Laboratories August 1997 - August 1999
Abbott Laboratories August 1995 - August 1997
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Clinical Development
Education
The University of Kansas 1989 — 1995
B.S., Pharmacy
Takeda Pharmaceuticals March 2011 - Present
Takeda Global Research and Development October 2008 - February 2011
Takeda Global Research and Development October 2005 - September 2008
Abbott Laboratories October 2003 - September 2005
Abbott Laboratories December 2001 - October 2003
Abbott Laboratories August 1999 - December 2001
Abbott Laboratories August 1997 - August 1999
Abbott Laboratories August 1995 - August 1997
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Clinical Development
Education
The University of Kansas 1989 — 1995
B.S., Pharmacy
Lillian Chu's Takeda Global Research and Development Experience 1994 - 2010
Job Recently retired Senior Research fellow at Takeda Global R&D Center, Inc. Takeda Pharmaceutical Products, Inc
Industry Pharmaceuticals
Experience
Takeda Global R&D Center, Inc. October 1994 - July 2010
Takeda Global Research and Development 1994 - 2010
TAP Pharmaceutical Products 1994 - 2008
TAP Pharmaceuticals 1994 - 2008
Skills
Pharmaceutical Industry, Infectious Diseases, Clinical Development, GCP, Clinical Trials, Drug Development, CRO, FDA, Oncology, Drug Discovery, Pharmacovigilance, Clinical Research, Biotechnology, Sop, Regulatory Affairs, ICH-GCP, Lifesciences
Education
University of Illinois at Chicago 1964 — 1971
Takeda Global R&D Center, Inc. October 1994 - July 2010
Takeda Global Research and Development 1994 - 2010
TAP Pharmaceutical Products 1994 - 2008
TAP Pharmaceuticals 1994 - 2008
Skills
Pharmaceutical Industry, Infectious Diseases, Clinical Development, GCP, Clinical Trials, Drug Development, CRO, FDA, Oncology, Drug Discovery, Pharmacovigilance, Clinical Research, Biotechnology, Sop, Regulatory Affairs, ICH-GCP, Lifesciences
Education
University of Illinois at Chicago 1964 — 1971
Bryan Ballog's Takeda Global Research and Development Experience May 2007 - July 2008
Job Country Manager US/PR HCV Site Operations at AbbVie
Industry Pharmaceuticals
Experience
AbbVie(formerly Abbott Labs) June 2012 - Present
Abbott Laboratories February 2011 - June 2012
Abbott Laboratories July 2008 - February 2011
Takeda Global Research And Development May 2007 - July 2008
PRA International February 2005 - May 2007
PharmaNet Development Group, Inc. December 2003 - February 2005
CareStat (Battelle CRO) March 2003 - December 2003
WorldCare Clinical, LLC 2002 - 2003
Perceptive Informatics 2001 - 2002
Skills
CTMS, Clinical Trials, Clinical Monitoring, EDC, HCV, Clinical Operations, Oncology, Therapeutic Areas, Clinical Research, Protocol, Central Nervous System, Clinical Research..., CRO, Immunology, Clinical Development, ICH-GCP, Infectious Diseases, Rheumatology, Drug Development, Neurology, Gastroenterology, Vaccines, Endocrinology
Education
Colorado State University
BS, Biological Sciences
AbbVie(formerly Abbott Labs) June 2012 - Present
Abbott Laboratories February 2011 - June 2012
Abbott Laboratories July 2008 - February 2011
Takeda Global Research And Development May 2007 - July 2008
PRA International February 2005 - May 2007
PharmaNet Development Group, Inc. December 2003 - February 2005
CareStat (Battelle CRO) March 2003 - December 2003
WorldCare Clinical, LLC 2002 - 2003
Perceptive Informatics 2001 - 2002
Skills
CTMS, Clinical Trials, Clinical Monitoring, EDC, HCV, Clinical Operations, Oncology, Therapeutic Areas, Clinical Research, Protocol, Central Nervous System, Clinical Research..., CRO, Immunology, Clinical Development, ICH-GCP, Infectious Diseases, Rheumatology, Drug Development, Neurology, Gastroenterology, Vaccines, Endocrinology
Education
Colorado State University
BS, Biological Sciences
Kimberly Gettens's Takeda Global Research and Development Experience March 2008 - March 2012
Job Associate Director, Clinical Project Management at Quintiles
Industry Pharmaceuticals
Experience
Quintiles May 2013 - Present
inVentiv Health Clinical October 2012 - May 2013
Takeda Global Research and Development March 2008 - March 2012
TAP Pharmaceuticals March 2005 - March 2008
Kendle 1998 - 2000
Education
DePaul University
Master of Business Administration (MBA)
Lafayette College 1991 — 1995
Bachelor of Arts (B.A.), Math & Economics
Quintiles May 2013 - Present
inVentiv Health Clinical October 2012 - May 2013
Takeda Global Research and Development March 2008 - March 2012
TAP Pharmaceuticals March 2005 - March 2008
Kendle 1998 - 2000
Education
DePaul University
Master of Business Administration (MBA)
Lafayette College 1991 — 1995
Bachelor of Arts (B.A.), Math & Economics
Vipin Arora, PhD's Takeda Global Research and Development Experience March 2008 - August 2010
Job Senior Research Advisor at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company 2014 - Present
Abbott Laboratories August 2010 - February 2014
Takeda Global Research and Development March 2008 - August 2010
Novartis Pharmaceuticals Inc. September 2004 - March 2008
Novartis 2004 - 2008
Eli Lilly October 1995 - September 2004
Skills
CRO, Clinical Development, Pharmaceutical Industry, Clinical Trials, Biostatistics, Drug Discovery, Clinical Data Management, FDA, Drug Development, Medical Affairs, Clinical Study Design, Clinical Pharmacology, Diabetes, Oncology, Clinical Research, Immunology, EDC, GCP, Lifesciences, Biomarkers, Therapeutic Areas, SAS, CDISC, CTMS, Statistical Programming, Regulatory Submissions, Data Management, Statistics, Medical Writing, Pharmacovigilance, Infectious Diseases, Sop, SOP, Protocol, ICH-GCP
Education
University of Nebraska-Lincoln 1989 — 1994
PhD, Mathematics and Statistics
University of Delhi 1975 — 1977
MS, Statistics
Univeristy of Delhi 1972 — 1975
BSc (Honors), Mathematics, Statistics
Eli Lilly and Company 2014 - Present
Abbott Laboratories August 2010 - February 2014
Takeda Global Research and Development March 2008 - August 2010
Novartis Pharmaceuticals Inc. September 2004 - March 2008
Novartis 2004 - 2008
Eli Lilly October 1995 - September 2004
Skills
CRO, Clinical Development, Pharmaceutical Industry, Clinical Trials, Biostatistics, Drug Discovery, Clinical Data Management, FDA, Drug Development, Medical Affairs, Clinical Study Design, Clinical Pharmacology, Diabetes, Oncology, Clinical Research, Immunology, EDC, GCP, Lifesciences, Biomarkers, Therapeutic Areas, SAS, CDISC, CTMS, Statistical Programming, Regulatory Submissions, Data Management, Statistics, Medical Writing, Pharmacovigilance, Infectious Diseases, Sop, SOP, Protocol, ICH-GCP
Education
University of Nebraska-Lincoln 1989 — 1994
PhD, Mathematics and Statistics
University of Delhi 1975 — 1977
MS, Statistics
Univeristy of Delhi 1972 — 1975
BSc (Honors), Mathematics, Statistics
Wei Qian's Takeda Global Research and Development Experience 2004 - Present
Job Statistical Programming
Industry Pharmaceuticals
Experience
Takeda Global Research and Development 2004 - Present
G. D. Searle 1997 - 2004
Skills
Statistical Programming, Clinical Trials, Pharmaceutical Industry, CRO, CDISC, SAS programming, SAS, Biostatistics, FDA, Regulatory Submissions, Drug Development, Sop, Clinical Research, Statistics, Unix, SDTM, Clinical Development, 21 CFR Part 11, Therapeutic Areas, Data Analysis
Education
Tsinghua University
University of Illinois at Chicago
University of Kentucky
Takeda Global Research and Development 2004 - Present
G. D. Searle 1997 - 2004
Skills
Statistical Programming, Clinical Trials, Pharmaceutical Industry, CRO, CDISC, SAS programming, SAS, Biostatistics, FDA, Regulatory Submissions, Drug Development, Sop, Clinical Research, Statistics, Unix, SDTM, Clinical Development, 21 CFR Part 11, Therapeutic Areas, Data Analysis
Education
Tsinghua University
University of Illinois at Chicago
University of Kentucky
David Breines's Takeda Global Research and Development Experience January 2002 - November 2009
Job Director, Regulatory Affairs, AbbVie Pharmaceuticals
Industry Pharmaceuticals
Experience
AbbVie August 2011 - Present
Baxter Healthcare November 2009 - August 2011
Takeda Global Research and Development January 2002 - November 2009
DuPont Pharmaceuticals July 1998 - December 2001
Education
Medical College of Ohio 1990 — 1994
Ph.D, Microbiology
Miami University 1985 — 1990
B.A., Microbiology
AbbVie August 2011 - Present
Baxter Healthcare November 2009 - August 2011
Takeda Global Research and Development January 2002 - November 2009
DuPont Pharmaceuticals July 1998 - December 2001
Education
Medical College of Ohio 1990 — 1994
Ph.D, Microbiology
Miami University 1985 — 1990
B.A., Microbiology
Kaori Tabion's Takeda Global Research and Development Experience January 2002 - November 2005
Job QA at Astellas Pharma Global Development
Industry Health, Wellness and Fitness
Experience
Astellas Pharma Global Development November 2005 - September 2010
Takeda Global Research and Development January 2002 - November 2005
Japan Health and Nutrition Food Association 日本健康栄養食品協会 2001 - 2002
Skills
GMP, Pharmaceutical Industry, Quality Assurance
Education
Case Western Reserve University School of Medicine 1998 — 2001
MS, Public Health and Nutrition
Showa Women's University 1992 — 1996
Bachelor of Arts (B.A.), Food Science & Nutrition
Astellas Pharma Global Development November 2005 - September 2010
Takeda Global Research and Development January 2002 - November 2005
Japan Health and Nutrition Food Association 日本健康栄養食品協会 2001 - 2002
Skills
GMP, Pharmaceutical Industry, Quality Assurance
Education
Case Western Reserve University School of Medicine 1998 — 2001
MS, Public Health and Nutrition
Showa Women's University 1992 — 1996
Bachelor of Arts (B.A.), Food Science & Nutrition
Eric Henning's Takeda Global Research and Development Experience July 2008 - August 2012
Job Senior Director, Global Program Management
Industry Pharmaceuticals
Experience
Takeda Pharmaceutical Company Ltd October 2014 - Present
Takeda Pharmaceuticals International August 2012 - Present
Takeda Global Research and Development July 2008 - August 2012
TAP Pharmaceuticals November 1998 - July 2008
TAP Pharmaceuticals May 1997 - November 1998
Abbott September 1995 - May 1997
Rush University Medical Center May 1995 - September 1995
Skills
Cross-functional Team..., Clinical Development, Strategy, Drug Development, Program Management, Project Management, Leadership, R&D, Clinical Research, Immunology, Marketing, Pharmaceutical Industry, CRO, Endocrinology, Gastroenterology, Oncology, Pharmaceutical Sales, Therapeutic Areas, Clinical Trials, Rheumatology
Education
Lake Forest Graduate School of Management 1998 — 2002
Master of Business Administration (M.B.A.)
Northern Illinois University 1991 — 1995
Major: Health Care Administration; Minor: Business Administration
Takeda Pharmaceutical Company Ltd October 2014 - Present
Takeda Pharmaceuticals International August 2012 - Present
Takeda Global Research and Development July 2008 - August 2012
TAP Pharmaceuticals November 1998 - July 2008
TAP Pharmaceuticals May 1997 - November 1998
Abbott September 1995 - May 1997
Rush University Medical Center May 1995 - September 1995
Skills
Cross-functional Team..., Clinical Development, Strategy, Drug Development, Program Management, Project Management, Leadership, R&D, Clinical Research, Immunology, Marketing, Pharmaceutical Industry, CRO, Endocrinology, Gastroenterology, Oncology, Pharmaceutical Sales, Therapeutic Areas, Clinical Trials, Rheumatology
Education
Lake Forest Graduate School of Management 1998 — 2002
Master of Business Administration (M.B.A.)
Northern Illinois University 1991 — 1995
Major: Health Care Administration; Minor: Business Administration
Pam Riggio's Takeda Global Research and Development Experience 1999 - 2005
Job Director of Regulatory Affairs at PharMEDium Services, LLC
Industry Pharmaceuticals
Experience
PharMEDium Services, LLC June 2015 - Present
PharMEDium Services, LLC January 2012 - Present
First Priority, Inc. January 2011 - January 2012
Hospira, Inc. April 2006 - October 2010
Baxter Healthcare Corporation 2005 - 2006
Takeda Global Research and Development 1999 - 2005
TAP Pharmaceuticals 1993 - 1999
Skills
Developing Regulatory..., Regulatory Product..., Regulatory Operations, Regulatory Strategy, Product Development, FDA, Pharmaceuticals, GMP, Regulatory Affairs, Clinical Development, Regulatory Requirements, ICH-GCP, Sop, Regulatory Submissions, Software Documentation, CAPA, 21 CFR Part 11, Change Control, Biotechnology, GCP, Drug Development, Computer System..., Clinical Trials, Quality Assurance, eCTD, Biopharmaceuticals, Aseptic Processing, Regulations, Medical Writing, CRO, Medical Devices, Pharmaceutical Industry, Pharmacovigilance, R&D, Strategy, Therapeutic Areas, Validation
Education
Drexel University College of Medicine 2007 — 2009
MS, Clinical Research Organization and Management
DePaul University 2003 — 2005
BA
PharMEDium Services, LLC June 2015 - Present
PharMEDium Services, LLC January 2012 - Present
First Priority, Inc. January 2011 - January 2012
Hospira, Inc. April 2006 - October 2010
Baxter Healthcare Corporation 2005 - 2006
Takeda Global Research and Development 1999 - 2005
TAP Pharmaceuticals 1993 - 1999
Skills
Developing Regulatory..., Regulatory Product..., Regulatory Operations, Regulatory Strategy, Product Development, FDA, Pharmaceuticals, GMP, Regulatory Affairs, Clinical Development, Regulatory Requirements, ICH-GCP, Sop, Regulatory Submissions, Software Documentation, CAPA, 21 CFR Part 11, Change Control, Biotechnology, GCP, Drug Development, Computer System..., Clinical Trials, Quality Assurance, eCTD, Biopharmaceuticals, Aseptic Processing, Regulations, Medical Writing, CRO, Medical Devices, Pharmaceutical Industry, Pharmacovigilance, R&D, Strategy, Therapeutic Areas, Validation
Education
Drexel University College of Medicine 2007 — 2009
MS, Clinical Research Organization and Management
DePaul University 2003 — 2005
BA
Jeff Soderquist's Takeda Global Research and Development Experience January 2007 - October 2011
Job Experienced Pharmaceutical Quality Executive
Industry Pharmaceuticals
Experience
Astellas Pharma March 2012 - Present
Encompass Consulting LLC November 2011 - March 2012
Takeda Global Research and Development January 2007 - October 2011
Takeda Pharmaceuticals May 2002 - January 2007
Skills
Quality Assurance, GCP, GMP, Drug Development, Quality Systems
Education
Keller Graduate School of Management of DeVry University 1990 — 1993
Masters, Business Administration
University of Wisconsin-Parkside 1977 — 1984
Bachelor of Science, Chemistry
Astellas Pharma March 2012 - Present
Encompass Consulting LLC November 2011 - March 2012
Takeda Global Research and Development January 2007 - October 2011
Takeda Pharmaceuticals May 2002 - January 2007
Skills
Quality Assurance, GCP, GMP, Drug Development, Quality Systems
Education
Keller Graduate School of Management of DeVry University 1990 — 1993
Masters, Business Administration
University of Wisconsin-Parkside 1977 — 1984
Bachelor of Science, Chemistry