Head of Medical Writing, West Coast Hub
Biogen
June 24, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Lead and advance the Medical Writing function for the West Coast Hub; establish standardized processes, policies, templates, and best practices for consistency, quality, and regulatory compliance.
- Provide strategic/operational oversight of clinical and regulatory writing activities, including authoring and guiding development of: clinical summaries/overviews for global marketing applications (e.g., NDA/BLA/MAA), clinical trial applications (INDs/CTAs), and key documents (e.g., protocols, CSRs, briefing documents).
- Manage and develop the Medical Writing team (performance management, mentorship, career development) to foster accountability, continuous learning, and high-quality delivery.
- Oversee resource planning/allocation and balance internal/external writing resources to meet portfolio demands, timelines, and quality expectations.
- Provide vendor oversight for external medical writing partners (quality, timelines, adherence to standards).
- Partner cross-functionally across R&D (Clinical, Regulatory, Biometrics, Safety) to deliver high-quality documents supporting program strategy and regulatory submissions.
- Drive continuous process improvement and scalable, fit-for-purpose writing processes.
- Represent Medical Writing in cross-functional initiatives and governance forums.
- Participate in workstreams advancing innovative tools/technologies to improve document preparation.
- Establish/enforce document planning/execution best practices; provide direct support/mentoring for complex or high-priority deliverables.
Qualifications/Skills (Required):
- Bachelor’s degree in life sciences/health discipline; advanced degree preferred.
- 12+ years biopharmaceutical industry experience.
- 8+ years direct medical writing experience.
- Expertise in clinical/regulatory document requirements; prior BLA/NDA experience strongly preferred.
- Experience managing a team of writers.
- Strategic influence, executive-level communication, and cross-functional leadership.
Skills (Preferred):
- Advanced degree.
- Experience with innovative tools/technologies in medical writing.
- Process improvement experience in medical writing.
Benefits:
- Base compensation range: $234,000.00–$322,000.00.
- Medical, Dental, Vision, and Life insurance; fitness/wellness reimbursement; short- and long-term disability; paid vacation plus end-of-year shutdown (Dec 26–Dec 31); up to 12 company holidays + 3 personal significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/calendar year); Employee Resource Groups participation.
- Lead and advance the Medical Writing function for the West Coast Hub; establish standardized processes, policies, templates, and best practices for consistency, quality, and regulatory compliance.
- Provide strategic/operational oversight of clinical and regulatory writing activities, including authoring and guiding development of: clinical summaries/overviews for global marketing applications (e.g., NDA/BLA/MAA), clinical trial applications (INDs/CTAs), and key documents (e.g., protocols, CSRs, briefing documents).
- Manage and develop the Medical Writing team (performance management, mentorship, career development) to foster accountability, continuous learning, and high-quality delivery.
- Oversee resource planning/allocation and balance internal/external writing resources to meet portfolio demands, timelines, and quality expectations.
- Provide vendor oversight for external medical writing partners (quality, timelines, adherence to standards).
- Partner cross-functionally across R&D (Clinical, Regulatory, Biometrics, Safety) to deliver high-quality documents supporting program strategy and regulatory submissions.
- Drive continuous process improvement and scalable, fit-for-purpose writing processes.
- Represent Medical Writing in cross-functional initiatives and governance forums.
- Participate in workstreams advancing innovative tools/technologies to improve document preparation.
- Establish/enforce document planning/execution best practices; provide direct support/mentoring for complex or high-priority deliverables.
Qualifications/Skills (Required):
- Bachelor’s degree in life sciences/health discipline; advanced degree preferred.
- 12+ years biopharmaceutical industry experience.
- 8+ years direct medical writing experience.
- Expertise in clinical/regulatory document requirements; prior BLA/NDA experience strongly preferred.
- Experience managing a team of writers.
- Strategic influence, executive-level communication, and cross-functional leadership.
Skills (Preferred):
- Advanced degree.
- Experience with innovative tools/technologies in medical writing.
- Process improvement experience in medical writing.
Benefits:
- Base compensation range: $234,000.00–$322,000.00.
- Medical, Dental, Vision, and Life insurance; fitness/wellness reimbursement; short- and long-term disability; paid vacation plus end-of-year shutdown (Dec 26–Dec 31); up to 12 company holidays + 3 personal significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/calendar year); Employee Resource Groups participation.