Brooke C.
Epista Life Science
Golden, CO, US
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MOBILE NUMBERS
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WORK HISTORY
Present
@Epista Life Science
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EDUCATION
2007 — 2008
Northeastern University
MS, Regulatory Affairs in Biologics, Drugs, and Medical Devices
2004 — 2006
Northeastern University
Graduate Certificate, International Regulatory Affairs
1998 — 2000
Holy Family University
BA, Computer Management Information Systems
SKILLS
Pharmaceutical IndustrySopFdaLife SciencesBiotechnologyCtmsRegulatory AffairsLifesciencesDocument ManagementU.s. Title 21 Cfr Part 11 RegulationGcp21 Cfr Part 11RegulationsRegulatory RequirementsIndManagementPharmacovigilanceGmpGood Clinical Practice (Gcp)Electronic Common Technical Document (Ectd)Clinical TrialsEctdRegulatory SubmissionsValidationCross-Functional Team LeadershipChange ControlStandard Operating Procedure (Sop)Computer System ValidationClinical DevelopmentU.s. Food and Drug Administration (Fda)DocumentumMedical Devices
ABOUT BROOKE C.
A leader in Life Sciences with a unique mix of experience combining technical aptitude…
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