Drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions
Responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment
Oversee document review coordination, including preparing and aligning reviewer rosters
Coordinate QC activities for clinical and regulatory documents, including working with external vendors to ensure timelines and deliverables are met
Ensure QC-reviewed and final documents are properly archived and traceable in Veeva
Develop and maintain document trackers for version history, ownership, and approvals to support audit readiness
Support documentation and tracking activities for audit and inspection readiness, including CAPA follow-up

7+ years in medical or regulatory writing operations within a GxP environment
Hands-on SOP authorship and routing experience, ideally with DOT or similar systems
Strong coordination and document control experience across review cycles, including experience with Veeva or similar regulatory document management systems
Experience coordinating CSR appendices and other cross-functional components of BLA submissions (e.g., Module 2 and 5 deliverables) is a plus
Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines
Strong interpersonal and communication skills, with proven ability to build trust across cross-functional teams
Exposure to regulatory submissions (INDs, BLAs, CTDs)
Well-versed in inspection-readiness documentation practices
Familiarity with CAPA documentation and inspection-readiness processes, including Medical Writing’s role in supporting inspection responses, is a plus

Medical Writing Operations Manager

Key skills