Medical Writing Operations Manager (Contract)

The Medical Writing Operations Manager will drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions. This role is responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment. The ideal candidate is detail-oriented, proactive, and highly organized, with demonstrated experience navigating regulated documentation and submission environments. Support development of the Investigator’s Brochure SOP and associated templates, including internal guidance documents and process aids. Coordinate QC activities for clinical and regulatory documents, including working with external vendors to ensure timelines and deliverables are met.