Director, Medical Writing
Core
Strategic leadership and hands-on execution for developing high-quality, compliant clinical and regulatory documents supporting drug development programs.
Role type
Director, Medical Writing
Builds
Clinical and regulatory submissions (protocols, CTD modules, clinical study reports) for FDA and global health authorities
Domain
Biotechnology / Neuromuscular diseases
Required skills
Medical writing strategy, FDA/regulatory compliance, document planning, resource management, cross-functional collaboration, scientific accuracy, process improvement
Preferred skills
Advanced degree in life sciences, biochemistry/molecular biology expertise, vendor management
Technologies
Microsoft Office, Adobe Acrobat, SharePoint
Responsibilities
Lead planning, authoring, review, and completion of clinical/regulatory documents; Manage internal and external medical writing resources; Author/edit protocols, investigator brochures, CTD modules, and briefing books; Review and refine documents for quality and regulatory adherence; Contribute to project planning and cross-functional working groups; Establish and improve medical writing processes and templates
Seniority
Director, strategic leadership with hands-on execution