Director, Medical Writing
About The Position
The 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 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 Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives.
Requirements
- Hands-on writing expertise
- Resource planning
- Matrix leadership
- Advanced technical judgment
Responsibilities
- Provides strategic and operational leadership for medical writing activities across one or more clinical development programs.
- Combines hands-on writing expertise with responsibilities for resource planning and matrix leadership.
- Delivers high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives.
- Accountable for document development strategy, planning, and execution.
- Leads clinical content development for complex submissions, including content strategy, organization, and resourcing.
- Partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings.
- Applies advanced technical judgment to solve complex problems.
- Ensures Medical Writing activities are integrated with broader development and regulatory objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
