Director, Medical Writing WCH
Biogen · Remote
Medical AffairsRemoteFull-time$191k–$263kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Biogen seeks a Director of Medical Writing to lead complex clinical and regulatory documentation programs across the West Coast Hub. This role involves managing medical writing teams, developing strategic regulatory documents, and collaborating with cross-functional departments on marketed and development-stage programs.
What they're looking for
- BSc with 12+ years medical writing experience, or advanced degree with 7+ years experience
- Demonstrated expertise in global regulatory submissions including BLA/NDA and MAA processes
- Proficiency with eCTD format and familiarity with ICH, FDA, and EMA guidelines
- Proven experience authoring regulatory documents and leading teams through authoring processes
- Strong project management skills with ability to manage multiple concurrent projects
- Expert proficiency in MS Word and document management systems such as Veeva or SharePoint
- Team management and/or mentoring experience preferred
What you'll be doing
- Author and oversee preparation of clinical and regulatory documents including protocols, CSRs, IBs, and regulatory submissions
- Lead planning, development, and delivery of documents per ICH guidelines, company SOPs, and regulatory requirements
- Manage and mentor in-house and contractor medical writers while ensuring high-quality deliverables
- Collaborate with clinical development, regulatory affairs, biostatistics, and other cross-functional teams on submission planning
- Represent medical writing in governance committee and regulatory agency meetings
Privacy & handoff
This role links to Biogen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.