Medical Writing Operations Manager

A company is looking for a Medical Writing Operations Manager (Contract).

Key Responsibilities

Support development of the Investigator's Brochure SOP and associated templates

Coordinate and track CSR appendices in partnership with cross-functional teams

Oversee document review coordination and ensure QC-reviewed documents are properly archived

Required Qualifications

7+ years in medical or regulatory writing operations within a GxP environment

Hands-on SOP authorship and routing experience

Strong coordination and document control experience across review cycles

Exposure to regulatory submissions (INDs, BLAs, CTDs)

Familiarity with CAPA documentation and inspection-readiness processes