Associate Director, Medical Writing

Job description

The Associate Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Associate Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Associate Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives. Accountable for medical writing deliverables across one or more clinical programs, contributing to program-level plans and ensuring aligned timelines, quality, and resourcing. Independen...