Position:
Document Specialist at McNeil Consumer Healthcare (Contractor - Pharma-Bioserve, Inc)
Location:
Greater Philadelphia Area
Industry:
Pharmaceuticals
Work:
McNeil Consumer Healthcare (Contractor - Pharma-Bioserve, Inc) - Fort Washington, PA since Mar 2013
Document Specialist
Pfizer Oct 2010 - Jul 2012
Senior Manager, Business Analyst
Wyeth Research Oct 2002 - Oct 2010
Associate Director, Clinical Records. Management. Operations
Wyeth Research 1995 - 2002
Manager, R&D Records Management
Bryn Mawr Hospital Jan 1987 - Jan 1994
Director, Materials Management
Education:
Saint Joseph's University 1984 - 1986
Master of Business Administration (M.B.A.), Health/Health Care Administration/Management
West Chester University of Pennsylvania 1978 - 1980
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General
Deleware County Community College 1975 - 1978
Associate of Science (A.S.), Computer Science
Skills:
Pharmaceutical Industry
Clinical Trials
GCP
21 CFR Part 11
Clinical Development
CTMS
Sop
CRO
Computer System Validation
ICH-GCP
EDC
FDA
Regulatory Submissions
Clinical Research
Validation
Electronic Document
Electronic Databases
Electronic Filing
Documentum
Documentations
Records Management
Information Management
FDA GMP
GxP
Migration Management
Regulatory Guidelines
Pharmacovigilance
Vaccines
Regulatory Affairs
Lifesciences
Biotechnology
Business Analysis
Data Migration
R&D
Protocol
