Medical Writing Operations Manager

Job Summary

Driving operational excellence in a remote full-time capacity, the Medical Writing Operations Manager will oversee document coordination, support SOP authorship, and ensure compliance for regulatory submissions while maintaining alignment across cross-functional teams.

Key responsibilities

• Support the development of the Investigator's Brochure SOP and associated templates, including internal guidance documents
• Coordinate and track CSR appendices in collaboration with cross-functional teams
• Manage document review coordination and oversee QC activities for clinical and regulatory documents

Required qualifications

• 7+ years in medical or regulatory writing operations within a GxP environment
• Hands-on experience with SOP authorship and routing, ideally with DOT or similar systems
• Strong coordination and document control experience, including familiarity with Veeva or similar systems
• Experience with regulatory submissions, including INDs, BLAs, and CTDs
• Well-versed in inspection-readiness documentation practices and CAPA processes