Senior Manager, Medical Writing
Alnylam Pharmaceuticals
August 18, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Produce high quality and on-time writing deliverables.
- Independently plan, write, edit, and format clinical documents including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries, and related documents.
- Facilitate/manage efficient review and finalization process for internally or externally produced documents (consultants, contractors, vendors).
- Represent Medical Writing on early-phase (multiple) or specific late-phase project teams; collaborate with the Director of Medical Writing on planning and resourcing for upcoming deliverables.
- Collaborate with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, Corporate Communications, and external stakeholders.
- Serve as subject matter expert for clinical documents and their production.
- Contribute to SOP and template development and maintenance.
Qualifications:
- Bachelor’s degree in Life Science (relevant writing expertise) or English/Communications (relevant science expertise); advanced degree and/or professional certification/credentials preferred.
- 6+ years as a medical writer in sponsor and/or CRO setting; experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting a plus.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process.
- Track record managing multiple fast-paced, deadline-driven projects with exceptional attention to detail and timely delivery.
- Overseeing contract writers is a plus; proficient with Microsoft Windows, Word, Excel, and PowerPoint.
- Ability to travel ~10%.
Benefits:
- Eligible for annual short-term incentive award and annual long-term incentive award (e.g., equity).
- Comprehensive benefits including medical/dental/vision, life and disability insurance, lifestyle reimbursement, flexible spending/HSAs, and 401(k) with company match; paid time off, wellness days, holidays, and recharge breaks.
Application instructions:
- Visit the Benefits section of the Careers website for additional benefits: https://www.alnylam.com/careers
- Produce high quality and on-time writing deliverables.
- Independently plan, write, edit, and format clinical documents including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries, and related documents.
- Facilitate/manage efficient review and finalization process for internally or externally produced documents (consultants, contractors, vendors).
- Represent Medical Writing on early-phase (multiple) or specific late-phase project teams; collaborate with the Director of Medical Writing on planning and resourcing for upcoming deliverables.
- Collaborate with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, Corporate Communications, and external stakeholders.
- Serve as subject matter expert for clinical documents and their production.
- Contribute to SOP and template development and maintenance.
Qualifications:
- Bachelor’s degree in Life Science (relevant writing expertise) or English/Communications (relevant science expertise); advanced degree and/or professional certification/credentials preferred.
- 6+ years as a medical writer in sponsor and/or CRO setting; experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting a plus.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process.
- Track record managing multiple fast-paced, deadline-driven projects with exceptional attention to detail and timely delivery.
- Overseeing contract writers is a plus; proficient with Microsoft Windows, Word, Excel, and PowerPoint.
- Ability to travel ~10%.
Benefits:
- Eligible for annual short-term incentive award and annual long-term incentive award (e.g., equity).
- Comprehensive benefits including medical/dental/vision, life and disability insurance, lifestyle reimbursement, flexible spending/HSAs, and 401(k) with company match; paid time off, wellness days, holidays, and recharge breaks.
Application instructions:
- Visit the Benefits section of the Careers website for additional benefits: https://www.alnylam.com/careers