Director Medical Writing
Alnylam Pharmaceuticals
June 26, 2026
Remote friendly (Cambridge, MA)
United States
$196,400 - $265,700 USD yearly
Clinical Research and Development
Overview
The Director, Medical Writing provides medical writing leadership for drug development programs, collaborates on clinical document strategy and development (including global regulatory submissions), and provides leadership/oversight within Medical Writing.
Key Responsibilities
- Lead medical writing strategy/efforts and ensure high-quality, on-time deliverables per regulations, GCP, and SOPs (e.g., protocols, amendments, investigator brochures, clinical study reports, biopharmaceutics, clinical pharmacology, safety/efficacy, clinical overviews, and related documents).
- Oversee, develop, and manage medical writers across multiple programs; provide coaching/mentorship and manage/train external writers/CROs.
- Communicate program goals/priorities to assigned medical writers.
- Plan/coordinate/oversee clinical filing dossiers with the Filing Excellence group.
- Independently plan, write, and edit high-quality, on-time deliverables as needed.
- Develop global department standards (templates, style guides, processes) and implement process improvements.
- Collaborate on planning and resourcing for upcoming writing deliverables.
- Partner with cross-functional teams (Data Sciences/Statistics, Clinical Ops, Clinical Development, Regulatory Affairs, Global Patient Safety/Risk Management, Early Development, Program Management, Research, Quality) and external stakeholders.
- Serve as subject matter expert for R&D document production and clinical document strategies.
Qualifications
- Bachelor’s in Life Science (with relevant writing expertise) or English/Communications (with relevant science expertise). Advanced degree and/or professional certification preferred.
- 10+ years medical writer experience in sponsor/CRO setting; sponsor experience strongly preferred.
- Experience leading/planning/writing/coordinating global clinical dossier filings (NDA/BLA/MAA) required; CTA/IND a plus.
- 3+ years managing medical writing direct reports.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and drug development process.
- Track record managing multiple deadline-driven projects.
- Excellent attention to detail; deliver with minimal oversight.
- Proficient in MS Office (Excel/Word/PowerPoint) and MS Project.
- Align with core values: Commitment to People; Fiercely Innovative; Purposeful Urgency; Open Culture; Passion for Excellence.
The Director, Medical Writing provides medical writing leadership for drug development programs, collaborates on clinical document strategy and development (including global regulatory submissions), and provides leadership/oversight within Medical Writing.
Key Responsibilities
- Lead medical writing strategy/efforts and ensure high-quality, on-time deliverables per regulations, GCP, and SOPs (e.g., protocols, amendments, investigator brochures, clinical study reports, biopharmaceutics, clinical pharmacology, safety/efficacy, clinical overviews, and related documents).
- Oversee, develop, and manage medical writers across multiple programs; provide coaching/mentorship and manage/train external writers/CROs.
- Communicate program goals/priorities to assigned medical writers.
- Plan/coordinate/oversee clinical filing dossiers with the Filing Excellence group.
- Independently plan, write, and edit high-quality, on-time deliverables as needed.
- Develop global department standards (templates, style guides, processes) and implement process improvements.
- Collaborate on planning and resourcing for upcoming writing deliverables.
- Partner with cross-functional teams (Data Sciences/Statistics, Clinical Ops, Clinical Development, Regulatory Affairs, Global Patient Safety/Risk Management, Early Development, Program Management, Research, Quality) and external stakeholders.
- Serve as subject matter expert for R&D document production and clinical document strategies.
Qualifications
- Bachelor’s in Life Science (with relevant writing expertise) or English/Communications (with relevant science expertise). Advanced degree and/or professional certification preferred.
- 10+ years medical writer experience in sponsor/CRO setting; sponsor experience strongly preferred.
- Experience leading/planning/writing/coordinating global clinical dossier filings (NDA/BLA/MAA) required; CTA/IND a plus.
- 3+ years managing medical writing direct reports.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and drug development process.
- Track record managing multiple deadline-driven projects.
- Excellent attention to detail; deliver with minimal oversight.
- Proficient in MS Office (Excel/Word/PowerPoint) and MS Project.
- Align with core values: Commitment to People; Fiercely Innovative; Purposeful Urgency; Open Culture; Passion for Excellence.