- Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities.
- Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards.
- Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials.
- Review and refine documents or document sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards.
- Contribute to project planning and cross-functional working groups to support efficient development, review, approval, and finalization of submission-ready documents.
- Establish and continuously improve medical writing processes, templates, and best practices.
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