Senior Manager, Regulatory Operations @ (October 2008 - April 2010)
Sr. Manager, Regulatory Operations and Corp. Doc Control @ (March 2005 - October 2008)
Application Support Specialist, Clinical and Regulatory @ Corixa Corporation (January 2003 - January 2005)
Desktop Support Specialist @ Corixa Corporation (January 2001 - January 2003)
Associate Digital Media Editor @ Imagine Media (January 1999 - January 2000)
Kevin Cooke Education
Howard University
Bachelor of Arts - BA (Interior Design)
1991-1995
Kevin Cooke Skills
IND
NDA
eCTD
Management
Regulatory Submissions
FDA
Clinical Development
Biotechnology
Validation
Pharmaceutical Industry
Computer System Validation
Sop
Biopharmaceuticals
21 CFR Part 11
Drug Development
Regulatory Documentation
GCP
Regulatory Operations
Clinical Research
Clinical Trials
CAPA
Regulatory Affairs
Quality System
CTMS
Change Control
CRO
GxP
Regulatory Requirements
GMP
GLP
Technology Transfer
Oncology
Pharmacovigilance
Clinical Data Management
Medical Writing
EDC
Vaccines
Protocol
Therapeutic Areas
Clinical Operations
Lifesciences
V&V
Pharmaceutics
Medical Affairs
Clinical Study Design
Regulations
Clinical Monitoring
Immunology
Life Sciences
Computer System
Kevin Cooke Summary
Kevin Cooke, based in California, United States, is currently a Marriage and Family Pastor at Reality San Francisco. Kevin Cooke brings experience from previous roles at FibroGen, Inc., MAP Pharmaceuticals, Gilead Sciences and PDL BioPharma. Kevin Cooke holds a 1991 - 1995 Bachelor of Arts - BA in Interior Design @ Howard University. With a robust skill set that includes IND, NDA, eCTD, Management, Regulatory Submissions and more. Kevin Cooke has 3 emails and 3 mobile phone numbers on RocketReach.
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