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Fran Quinn

Director Us Lifecycle Sm and Compliance @辉瑞

Pottstown, PA, US
EMAILS
[email protected]
MOBILE NUMBERS
+12•••••••16

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WORK HISTORY

Jun 2025 — Present

Director Us Lifecycle Sm and Compliance @辉瑞

Collegeville, PA, US

Director leading Global teams across multiple countries and time zones to oversee and manage the US Portfolio concentrating on Lifecycle and compliance submissions across IND and Marketed products. Also lead a parallel global teams supporting Annual Reporting Contributions collections including all NDA, BLA, PADERS. Drug Listing, CARES ACT and SPL Creation.

EDUCATION

2003 — 2008

Villanova University

Bachelor of Science, Leadership

SKILLS

Regulatory RequirementsIndVaccinesCROIch Guidelines21 CfrEctdPharmaceutical IndustrySopFdaIch-GcpDocument ManagementProject Portfolio ManagementRegulatory AffairsNdaIsi ToolboxProcess ImprovementNeesData ManagementSharepointRegulatory DocumentationValidationMicrosoft OfficeAdobe AcrobatMedical WritingDrug DevelopmentGcpClinical TrialsRegulatory FilingsSoftware DocumentationCtmsRegulatory SubmissionsLeadershipPharmacovigilance21 Cfr Part 11RegulationsCross-Functional Team LeadershipComputer System ValidationAndaR

ABOUT FRAN QUINN

Director at Pfizer Submission Mgmt and compliance

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