Otsuka Pharmaceutical Development & Commercialization
Industry: Pharmaceutical company
DescriptionFounded: 1985 Parent organization: Otsuka Pharmaceutical
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Otsuka Pharmaceutical Development & Commercialization Employees
Otsuka Pharmaceutical Development & Commercialization July 2014 - Present
Missouri State University June 2002 - Present
University of Kentucky July 2012 - June 2014
Private Practice Obstetrics/Gynecology/Infertility July 1998 - October 2011
St. John's Regional Medical Center July 1997 - June 1998
St. John's Regional Medical Center July 1994 - June 1997
Skills
Drug Safety, Pharmacovigilance, Epidemiology, Patient Safety, Preventive Medicine, Obstetrics, Gynecology, Fertility, Population Health, Reproductive Medicine, Evidence-based Medicine, Public Health, Medical Education, Medical Writing, Pharmacoepidemiology, Biostatistics, Medical Research, Health Services Research, Infertility, Global Health, Quality Improvement, Infectious Diseases
Education
University of Kentucky College of Medicine 2012 — 2014
Masters of Public Health, Health Systems Management
University of Kentucky College of Medicine 2012 — 2014
Residency Training, Preventive Medicine
St. Johns Mercy Medical Center 1994 — 1998
Residency Training, Obstetrics and Gynecology Residency Program
St. Louis University School of Medicine 1988 — 1994
Doctor of Medicine (M.D.), Ph.D., Physiology
Otsuka Pharmaceutical Development & Commercialization July 2012 - Present
Eisai Inc. October 2008 - May 2012
Eisai Medical Research 2002 - September 2008
Purepac Pharmaceuticals December 1999 - June 2002
Alpharma 1999 - 2002
Ciba-Geigy/Novartis 1990 - 1999
Skills
Project Management, Program Management, Project Portfolio..., Project Planning, Business Operations, Operating Budgets, Contract Management, Vendor Management, Contract Negotiation, Clinical Trials, Oncology, Drug Development, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, GCP, Regulatory Submissions, Lifesciences, R&D, Pharmacovigilance, CTMS, GMP, Regulatory Affairs, Biotechnology, CRO, FDA, Pharmaceutics, Sop, Cross-functional Team..., IND, Biopharmaceuticals
Education
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Biology, General
Rutgers, The State University of New Jersey-New Brunswick
M.S., Zoology
Otsuka Pharmaceutical Development & Commercialization October 2008 - Present
Yamik Ltd 2005 - July 2008
King Bell LLC February 2008 - June 2008
Rosenthal Partners 2007 - 2007
R House Lettings 1995 - 2007
Skills
Microsoft Excel, Microsoft Office, Microsoft Publisher, Project Management, Microsoft Project..., Microsoft Office..., Time Management, Management, Life Cycle Planning, Global Clinical..., Clinical Trials, Clinical Research, Phase 1 Clinical Trials, Phase 2 Clinical Trials, Phase 3 Clinical Trials, European Regulatory..., Meeting Planning, Meeting Management, Interpersonal..., Cross-functional Team..., Oracle E-Business Suite, MS Project, Program Management, New Business Development, Regulatory Submissions, CTMS, GCP, Business Development, Event Management, Drug Development, Clinical Development, CRO, FDA, Protocol, Therapeutic Areas, Project Planning, Infectious Diseases, Marketing Strategy, Biotechnology, Marketing, Validation, Regulatory Requirements, Clinical Data Management, Analysis, SharePoint, Pharmaceutical Industry, Medical Writing, EDC, Product Development, Regulatory Affairs
Education
Liverpool John Moores University 1990 — 1994
BA (hons), Business
Liverpool John Moores University
Bachelor of Arts (B.A.), Business, Finance and Marketing
Otsuka Pharmaceutical Development & Commercialization October 2012 - Present
Bristol-Myers Squibb June 2011 - November 2012
Bristol-Myers Squibb, Princeton, New Jersey November 2010 - June 2012
MERCK & CO., INC December 2002 - November 2010
PETROTOX, LLC January 2000 - January 2002
MOBIL OIL CORP January 1998 - January 2000
Mobil Oil January 1995 - January 1998
Skills
Pharmaceutics, Therapeutic Areas, Cross-functional Team..., Strategic Planning, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, Regulatory Affairs, Lifesciences, Sop, Drug Development, Regulatory Requirements
Education
Richard Stockton College of NJ
B.S, Biology
Rutgers University
M.S, Biology Coursework
University of Pennsylvania
M.S, Biological Science/Toxicology
Regeneron Pharmaceuticals January 2011 - Present
Regeneron Pharmaceuticals April 2009 - December 2010
Otsuka Pharmaceutical Development & Commercialization October 2007 - April 2009
Encysive Pharmaceuticals January 2006 - September 2007
Encysive Pharmaceuticals January 2004 - January 2006
Pfizer Inc. October 2001 - September 2003
Pfizer Inc. December 2000 - October 2001
Pfizer Inc. May 2000 - December 2000
Parke-Davis/Warner-Lambert (Acquired by Pfizer in June 2000) June 1999 - May 2000
Olsten Staffing Services (Parke-Davis/Warner-Lambert) December 1998 - June 1999
Education
Cleary University 2002 — 2003
BBA
Cleary University 2002 — 2003
Otsuka America Pharmaceutical, Inc. April 2013 - Present
FDA April 2008 - March 2013
Otsuka Pharmaceutical Development & Commercialization July 2005 - April 2008
Otsuka Maryland Research Institute November 2001 - July 2005
Computer Sciences Corporation June 1996 - November 2001
Skills
Project Management, Program Management, Business Analysis, Business Process, Management Consulting, Vendor Management, Integration, Management, Training, Cross-functional Team..., Software Documentation, Change Management, Business Intelligence, Quality Assurance, Leadership, SharePoint, Consulting
Education
Cornell University
Bachelor of Science (B.S.)
University of Delaware
Otsuka Pharmaceutical Development & Commercialization February 2013 - Present
Bristol-Myers Squibb Co. September 2009 - January 2013
Bristol-Myers Squibb September 2003 - September 2009
Image Solutions, Inc. January 2001 - August 2003
GfK Market Measures 1999 - 2001
Skills
21 CFR Part 11, Biopharmaceuticals, Biotechnology, Business Process..., CRO, CTMS, Clinical Development, Clinical Research, Clinical Trials, Cross-functional Team..., FDA, Lifesciences, ICH-GCP, Medical Devices, Management, IND, Oncology, Process Improvement, Regulatory Submissions, Medical Writing, Project Management, Strategy, Therapeutic Areas, Validation, Sop, Drug Development, Pharmaceutical Industry, Product Launch, GMP, Regulatory Affairs, Technology Transfer
Education
Temple University 2004 — 2006
M.S., Regulatory Affairs/Quality Assurance
Rutgers University-New Brunswick 1994 — 1999
Otsuka Pharmaceutical Development & Commercialization May 2015 - Present
Otsuka Pharmaceutical Development & Commercialization August 2011 - Present
Otsuka America Pharmaceutical, Inc. July 2004 - July 2011
Skills
Pharmaceutical Industry, Validation, SOP, Biotechnology
Education
Bucknell University 2000 — 2004
Bucknell University
Sara Dorfman Smith, LLC March 2007 - Present
Otsuka Pharmaceutical Development & Commercialization September 2004 - March 2007
3M Pharmaceuticals June 2003 - April 2004
MannKind Corporation July 2001 - February 2003
Genentech 1998 - 2001
Skills
GMP, Validation, Biotechnology, Sop, Quality Management, Quality Assurance, CAPA, Biopharmaceuticals, Clinical Development, GLP, Clinical Trials, GxP, Pharmaceutical Industry, FDA, Quality Auditing, Quality Control, Laboratory, Life Sciences, Management, CRO, GCP, GDP, Pharmaceutical, Regulatory
Education
University of California, Davis 1993 — 1998
Henry M Gunn High School 1989 — 1993
Otsuka Pharmaceutical Companies (U.S.) October 2012 - Present
Adali Consulting, Inc. February 1998 - October 2012
Otsuk Pharmaceutical Development & Commercialization February 2010 - September 2012
The Total Approach September 2009 - February 2010
Otsuka Pharmaceutical Development & Commercialization November 2008 - June 2009
GenVec Inc. May 2007 - May 2008
GenVec December 2006 - May 2007
Nabi BioPharmaceuticals April 2005 - November 2006
OMRI May 2003 - March 2005
Omnicare Clinical Research April 2002 - September 2004
Skills
Oncology, Clinical Research, Pain, Consulting, Infectious Diseases, Clinical Trials, Clinical Development, FDA, Sop, CRO, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, GCP, EDC, Cardiology, CTMS, Hematology, Pain Management, Clinical Data Management, Clinical Monitoring, Protocol, Immunology, Regulatory Submissions, Vaccines, Data Management, Clinical Operations, Lifesciences, Medical Writing, ICH-GCP, Pharmacovigilance, Oracle Clinical, Pharmaceutics, Neurology, Drug Development, Medical Devices, Medical Affairs, Endocrinology, Dermatology, Clinical Study Design, Phase I, 21 CFR Part 11, IND, Life Sciences, SOP
Education
Marquette University
MBA, Business Administration, General
Marquette University
BSN, Nursing
Otsuka Pharmaceutical Development & Commercialization November 2012 - Present
InfaCare Pharmaceutical Corporation April 2009 - November 2012
Bristol-Myers Squibb October 2005 - March 2009
RPS, Inc. May 2004 - September 2005
Johnson & Johnson Pharmaceutical Research & Development 2002 - 2004
Johnson & Johnson Pharmaceutical Research & Development 1999 - 2002
Janssen Research Foundation 1997 - 1999
IBAH, Inc. (currently Omnicare Clinical Research) September 1994 - June 1997
G. H. Besselaar Associates (currently Covance) October 1991 - July 1994
Skills
Hypertension, CRO, CTMS, Osteoporosis, GI, Clinical Trials, Clinical Research, GCP, Neuroscience, Pharmacology, Medical Writing, Clinical Development, Clinical Monitoring, Medical Affairs, Clinical Operations, Drug Development, Pharmaceutical Industry, Oncology, EDC, Central Nervous System, Regulatory Submissions, Regulatory Requirements, Therapeutic Areas, Protocol, Infectious Diseases, Regulatory Affairs, Neurology, Cardiology, FDA, Diabetes, Dermatology, ICH-GCP
Education
Pepperdine University 1980 — 1982
BA, Pre-Med, Psychology
Mercer County Community College 1977 — 1980
A.A.S., Medical Technology, Psychology
Otsuka Pharmaceutical Development & Commercialization April 2009 - Present
Bristol-Myers Squibb November 2004 - April 2009
BMS 1989 - 2009
Bristol-Myers Squibb November 1999 - November 2004
Bristol-Myers Squibb October 1989 - November 1999
Skills
Medicine, Commercialization, Product Development, Oncology, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Clinical Research, Biotechnology, Drug Development, Urology, Medical Affairs, Drug Discovery, Neurology, Dermatology, Product Launch, FDA, Medical Writing, Lifesciences, Neuroscience, Cardiology, Pharmaceutical Sales, CRO, Endocrinology, Regulatory Affairs, Sales Effectiveness, Cross-functional Team..., Diabetes, Infectious Diseases, Market Access, Regulatory Submissions, Life Sciences
Education
University of Medicine and Dentistry of New Jersey 1976 — 1981
PhD, Pharmacology
Seton Hall University 1973 — 1976
MS, Physiology
La Salle University 1969 — 1973
BA, Biology
Astex Pharmaceuticals, an Otsuka Company January 2015 - Present
Otsuka Pharmaceutical Development & Commercialization August 2013 - Present
Otsuka Pharmaceutical Development & Commercialization October 2010 - August 2013
Astellas March 2008 - October 2010
Skills
SAS, Statistical Modeling, R, Statistics, Clinical Trials, Biostatistics, SAS Programming, Data Analysis, Analytics, Data Mining
Education
University of Minnesota-Twin Cities 1999 — 2007
PhD, Statistics