Eisai Medical Research Inc.
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Eisai Medical Research Inc. Employees
Eisai Inc June 2010 - May 2011
Eisai Medical Research Inc March 2003 - June 2010
Eisai Medical Research Inc January 2002 - March 2003
Eisai, Inc January 1996 - January 2002
Eisai, Inc January 1988 - January 1996
John N Castellucci, MD, PA January 1972 - January 1988
Skills
Meeting Planning, Pharmaceutical Industry, Clinical Trials, Therapeutic Areas, Clinical Development, CTMS, Drug Development, EDC, Budgets, Healthcare, Management, CRO, Cross-functional Team..., Software Documentation, GCP, Oncology, Medical Devices, Neurology, Medical Affairs, Protocol, Pharmaceutical Sales, Regulatory Affairs, Regulatory Submissions, Data Management, Biotechnology, Clinical Research, Pharmacovigilance, Gastroenterology, Biopharmaceuticals, Medical Writing, Sop, Infectious Diseases, FDA, Clinical Data Management
Education
Hofstra University
Associate of Arts, Mathematics, Sociology
East Orange General Hospital May 2014 - Present
Unlimited Taxes May 2009 - September 2013
Merck & Co. Inc June 2008 - April 2009
Novartis Pharmaceutical Corporation May 2007 - May 2008
Eisai Medical Research Inc April 1999 - May 2007
Innovex-DAS October 1996 - November 1999
Roche Biomedical (Lab Corp) April 1993 - September 1996
Skills
Clinical Data Management, CRO, Clinical Trials, Oncology, Pharmaceutical Industry, FDA, Data Management, CRF design, CDISC, EDC, Inform, Protocol, CTMS, GCP, Clinical Development, 21 CFR Part 11, Pharmacovigilance, Clinical Monitoring, Sop, Regulatory Affairs, ICH-GCP, Therapeutic Areas, Clinical Operations
Education
University of Phoenix 2004 — 2006
Bachelor of Science, HealthCare Administration
university of phoenix 2003 — 2006
Health Care Administration
Vitech Systems Group July 2015 - Present
Vitech Systems Group July 2011 - Present
Eisai Medical Research Inc August 2007 - March 2011
Virage Logic Corporation December 1999 - August 2007
Mentor Graphics September 1994 - December 1999
Xerox June 1994 - August 1994
Pennsylvania State University Center for Academic Computing 1990 - 1994
Skills
Software Documentation, VMware, VMware ESX, Solaris, Operating Systems, Hardware, Windows, Servers, System Administration, Virtualization, Linux, TCP/IP, Blackberry Enterprise..., Lotus Domino..., Solarwinds, Citrix, Security, Microsoft Exchange, Troubleshooting, Storage, Active Directory, Disaster Recovery, Data Center, DNS, Windows Server, Red Hat Linux, VPN, Perl, Networking, SAN, High Availability, Databases, Integration, NAS, Cisco Technologies, Infrastructure, Testing, ITIL, Software Development
Education
Penn State University 1987 — 1992
BS, Electrical Engineering
Bishop Shanahan High School 1983 — 1987
High School
St John's Dunellen NJ 1979 — 1983
Pharmaceuticals July 2012 - Present
Hoffman La Roche, Inc June 2007 - 2011
Global Regulatory Ops August 2005 - June 2007
Clinical Research QA Mt. Sinai School of Medicine September 2003 - August 2005
Eisai Medical Research, Inc January 2000 - September 2003
Advanced Biologics 2000 - 2002
Skills
SOP, FDA, GCP, CRO, Quality Assurance, Auditing, Clinical, Quality Auditing, Inspection, CAPA, Regulatory Affairs, Clinical Trials, GLP, GxP, Pharmaceuticals, Clinical Research, 21 CFR Part 11, Regulatory Requirements, Quality Systems, IND, Documentation, Document Management, Compliance, Quality Management, Clinical Trial..., Sop
Education
Old Dominion University 1996 — 2000
Bachelor of Science, Biology
Gilead Sciences July 2011 - Present
Columbia University September 2006 - May 2011
National Cancer Institute June 2010 - August 2010
Pfizer Inc. June 2009 - August 2009
Eisai Medical Research Inc. June 2008 - August 2008
Skills
R, SAS, Cluster Analysis, Statistics, Research, Biostatistics, Data Analysis, Statistical Modeling, Survival Analysis, Time Series Analysis, Data Mining
Education
Columbia University in the City of New York 2006 — 2011
Ph.D., Statistics
Tsinghua University 2002 — 2006
BS, Mathematics
Shanghai High School 1999 — 2002
Regeneron Pharmaceuticals, Inc. October 2014 - Present
Novartis June 2011 - July 2014
Related April 2011 - June 2011
Swiss Re America Holding Corporation October 2007 - February 2011
Eisai Medical Research Inc. December 2006 - October 2007
Merck & Co., Inc. September 2006 - November 2006
Johnson&Johnson October 2004 - September 2006
Norvergence 2003 - 2004
Aerotek 2001 - 2003
Teksystems 2001 - 2003
Skills
Talent Acquisition, Applicant Tracking..., Sourcing, Internet Recruiting, Technical Recruiting, Talent Management, Recruiting, Onboarding, Executive Search, College Recruiting, Employee Relations, Benefits Negotiation, Human Resources, Vendor Management, Performance Management
Education
Fairleigh Dickinson University-Florham Campus 1997 — 2000
BS
The Citadel 1995 — 1997
Millburn High School 1991 — 1995
Axiom May 2012 - Present
Eisai Inc. July 2007 - May 2012
Eisai Medical Research Inc. 2007 - 2012
Johnson & Johnson December 2006 - June 2007
Pfizer December 2001 - December 2006
Warner-Lambert Company 1997 - 2001
Warner-Lambert Company 1989 - 1997
Lanid Corporation 1985 - 1989
Lanid Corporation 1985 - 1989
Lanid Corporation 1985 - 1989
Skills
Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, Lifesciences, Legal Documents, Clinical Trials, Biotechnology, Licensing, Legal, Legal Writing, Regulatory Submissions, Legal Advice, Medical Devices, Clinical Development, FDA, Strategy, Cross-functional Team..., CTMS, Commercialization, Change Control, Intellectual Property, Regulatory Requirements, Pharmaceutics, FCPA, Patents
Education
Rutgers University School of Law - Newark 1997 — 2001
J.D.
Montclair State University 1960 — 1964
BA & MA, English
Other
Bachelor's degree, English Language and Literature, General
Neurovance Inc. October 2014 - Present
Euthymics Bioscience Inc. July 2013 - October 2014
Neurovance Inc. July 2013 - October 2014
Teva Pharmaceuticals July 2011 - March 2013
Eisai Medical Research Inc. December 2005 - May 2011
Eisai 2005 - May 2011
Somaxon Pharmaceuticals August 2004 - May 2005
Pfizer Medical Affairs Neuroscience 2000 - 2004
Pfizer Pharmaceuticals, New York 1998 - 2004
Pfizer 1997 - 2004
Skills
Clinical Development, Clinical Trials, Pharmaceutical Industry, Clinical Research, Neurology, Drug Development, Oncology, CRO, CTMS, GCP, Neuroscience, Therapeutic Areas, Medical Affairs, Translational Medicine, Diabetes, Biotechnology, Psychiatry, Regulatory Affairs, Pharmacovigilance, Infectious Diseases, Pharmaceutics, Medicine, Biopharmaceuticals, EDC, Lifesciences, Regulatory Submissions, Medical Writing, FDA, Clinical Study Design, Pharmacology, Clinical Pharmacology, IND, Clinical Operations, Clinical Monitoring, Protocol, Clinical Data Management, Life Sciences
Education
Michigan State University 1974 — 1978
Doctor of Medicine (M.D.), Medicine
Harvard College 1970 — 1974
Bachelor of Arts (B.A.), Biology and Economics
Bloomfield Hills Andover High School 1967 — 1970
Diploma
Seidlin Consulting LLC 2007 - Present
Eisai Global Clinical Research (ECG) 2002 - 2007
Eisai Medical Research Inc 2001 - 2007
Aventis Pharmaceuticals 1999 - 2001
Daiichi Sankyo 1994 - 1999
American Cyanamid 1992 - 1995
NYU Medical School 1985 - 1992
National Institutes of Health 1981 - 1984
Skills
Clinical Development, Clinical Research, Pharmaceutical Industry, Oncology, Clinical Trials, Biotechnology, Medical Writing, Lifesciences, Drug Development, GCP, Regulatory Submissions, Regulatory Affairs, Neurology, Regulatory Requirements, Diabetes, 21 CFR Part 11, Neuroscience, FDA, Immunology, Biopharmaceuticals, Cancer, Pharmacology, Dermatology, CTMS, Therapeutic Areas, Medical Devices, GLP, Sop, Medicine, Cardiology, Drug Design, Infectious Diseases, Vaccines, Drug Discovery, Pharmaceutics, Pharmaceutical Sales, Technology Transfer, Life Sciences, SOP
Education
Harvard Medical School 1973 — 1977
Doctor of Medicine (M.D.)
Barnard College 1969 — 1973
AB, Biochemistry, Biology
Eisai Medical Research Inc.
Skills
Clinical Research, Clinical Trials, Clinical Development, GCP, Pharmacology, Bioanalysis, R&D, Regulatory Affairs, Pharmaceutical Industry, Drug Development, Clinical Pharmacology, Project Management, Therapeutic Areas, Sop, Oncology, FDA, Medical Writing, CRO, Medical Affairs, Neurology, CTMS, Program Management, Lifesciences
Education
Rutgers University-New Brunswick 1976 — 1981
Eisai Inc. June 2015 - Present
Eisai Inc. June 2010 - May 2015
Eisai Inc. August 2008 - May 2010
Eisai Medical Research August 2007 - August 2008
Eisai Medical Research Inc. June 2006 - July 2007
Eisai Medical Research Inc. February 2003 - June 2006
Eisai Inc. November 2001 - February 2003
Eisai May 2001 - October 2001
ARC of Bergen and Passaic April 2000 - February 2001
Center for the Disabled January 1994 - March 2000
Skills
Document Management, Microsoft Office, Business Process, Pharmaceuticals, Regulatory Submissions, Documentum, Regulatory Affairs, SOP, FDA, Validation, Documentation, Compliance, eCTD, Adobe Acrobat, Change Control, IND, Cross-functional Team..., Process Improvement, Word, Situational Leadership, Situational Self..., NDA, Global Dossier, Project Management, Emotional Intelligence, CRO, Sop, Drug Development, Pharmaceutical Industry, Quality Assurance, EDC, Clinical Development
Education
University of Phoenix 2005 — 2007
MBA, Business Administration
Excelsior College 2004 — 2005
BS, Psychology
Bayer HealthCare Pharmaceuticals Inc. July 2012 - Present
Novartis March 2011 - July 2012
Novartis September 2008 - February 2011
Novartis September 2007 - September 2008
Eisai Medical Research Inc. October 2005 - September 2007
OSI Pharmaceuticals Inc. August 2001 - October 2005
OSI Pharmaceuticals Inc. March 2001 - June 2001
Novartis Pharmaceuticals Canada Inc. February 1997 - February 2001
Ciba-Geigy Canada Inc. September 1996 - February 1997
Inveresk Research January 1995 - April 1996
Education
University of Plymouth 1981 — 1984
BS Combined Studies (Sciences), Chemistry and Applied Biology