Director, Medical Writing - WCH
Biogen
August 13, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Write and/or manage complex marketed and development programs at the portfolio level based on therapeutic area, disease state, and phase.
- Supervise Medical Writing program leads; address Medical Writing issues with internal cross-functional teams and external development partners.
- Plan, develop, and deliver clinical/regulatory documents per ICH, company SOPs, templates, and regulatory requirements (protocols/amendments, CSRs, IBs, INDs/CTAs, submissions).
- Ensure scientific accuracy/consistency; develop and integrate medical writing strategy and messaging.
- Collaborate with SMEs (Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Clinical Operations) and support regulatory submission planning/timelines.
- Manage/oversight of in-house and contractor medical writers; mentor junior writers; serve as Medical Writing liaison to one or more FSPs.
- Review SAPs and clinical data reports incorporated into data-related documents; provide strategic input to streamline outputs.
- Maintain industry knowledge and establish medical writing best practices.
Qualifications / Required Skills:
- BSc + 12 years Medical Writing, or advanced degree + 7 years (pharma/biotech/CRO).
- Experience with global regulatory submissions (e.g., BLA/NDA, MAA).
- Familiarity with eCTD and document relationships.
- Knowledge of ICH, FDA, EMA guidelines and public disclosure requirements.
- Proven document authoring and leading teams through authoring.
- Strong project management; prioritize multiple projects in fast-paced environment.
- SME in MS Word; proficiency with Veeva/SharePoint.
Preferred:
- Experience mentoring/managing other medical writers or external vendors.
Compensation & Benefits (if applicable to role):
- Base salary range: $191,000–$263,000.
- Medical/Dental/Vision/Life; fitness reimbursement; short/long-term disability; paid vacation (+ end-of-year shutdown); paid holidays; sick time; paid maternity/parental leave; 401(k) match; ESPP; tuition reimbursement up to $10,000/year; ERG participation.
- Write and/or manage complex marketed and development programs at the portfolio level based on therapeutic area, disease state, and phase.
- Supervise Medical Writing program leads; address Medical Writing issues with internal cross-functional teams and external development partners.
- Plan, develop, and deliver clinical/regulatory documents per ICH, company SOPs, templates, and regulatory requirements (protocols/amendments, CSRs, IBs, INDs/CTAs, submissions).
- Ensure scientific accuracy/consistency; develop and integrate medical writing strategy and messaging.
- Collaborate with SMEs (Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Clinical Operations) and support regulatory submission planning/timelines.
- Manage/oversight of in-house and contractor medical writers; mentor junior writers; serve as Medical Writing liaison to one or more FSPs.
- Review SAPs and clinical data reports incorporated into data-related documents; provide strategic input to streamline outputs.
- Maintain industry knowledge and establish medical writing best practices.
Qualifications / Required Skills:
- BSc + 12 years Medical Writing, or advanced degree + 7 years (pharma/biotech/CRO).
- Experience with global regulatory submissions (e.g., BLA/NDA, MAA).
- Familiarity with eCTD and document relationships.
- Knowledge of ICH, FDA, EMA guidelines and public disclosure requirements.
- Proven document authoring and leading teams through authoring.
- Strong project management; prioritize multiple projects in fast-paced environment.
- SME in MS Word; proficiency with Veeva/SharePoint.
Preferred:
- Experience mentoring/managing other medical writers or external vendors.
Compensation & Benefits (if applicable to role):
- Base salary range: $191,000–$263,000.
- Medical/Dental/Vision/Life; fitness reimbursement; short/long-term disability; paid vacation (+ end-of-year shutdown); paid holidays; sick time; paid maternity/parental leave; 401(k) match; ESPP; tuition reimbursement up to $10,000/year; ERG participation.