Director, Medical Writing
Core
Provide leadership and oversight for medical writing efforts on drug development programs, ensuring high-quality clinical documents for global regulatory submissions.
Role type
Director, Medical Writing
Builds
Clinical dossiers (NDA/BLA/MAA), clinical protocols, study reports, and regulatory summaries for RNAi therapeutics.
Domain
Biopharmaceuticals / Clinical Development / Regulatory Affairs
Deliverable
client delivery
Required skills
Medical writing strategy, regulatory document preparation (NDA/BLA/MAA), team management, project planning, SOP compliance, cross-functional collaboration
Preferred skills
Advanced degree, professional certification, sponsor experience, CTA/IND experience
Technologies
MS Office Suite, MS Project
Responsibilities
Lead medical writing strategy for drug development programs; oversee and mentor internal and external writers; coordinate clinical filing dossiers; develop global department standards; serve as subject matter expert for R&D documents.
Seniority
Director, strategic leadership & management
