Director Medical Writing
Alnylam Pharmaceuticals
2 months ago
Remote friendly (Cambridge, MA)
United States
$196,400 - $265,700 USD yearly
Clinical Research and Development
Key Responsibilities:
- Lead Medical Writing efforts and strategy for drug development programs; ensure high-quality, on-time deliverables in compliance with regulations, Good Clinical Practices (GCP), and SOPs (including clinical protocols, amendments, investigator brochures, clinical study reports, biopharmaceutics summaries, clinical pharmacology, clinical safety/efficacy, clinical overviews, and related documents).
- Oversee, develop, and manage medical writers across multiple programs; provide leadership, coaching, guidance, mentorship; manage and train external writers/CROs.
- Communicate program goals and priorities to assigned medical writers.
- Plan, coordinate, oversee, and drive clinical filing dossiers with the Filing Excellence group.
- Independently plan, write, and edit high-quality, on-time writing deliverables as needed.
- Contribute to global department standards (templates, style guides, and processes) and implement process improvements.
- Collaborate with Medical Writing leadership to ensure appropriate planning and resourcing.
- Partner with Data Sciences & Statistics, Clinical Operations, Clinical Development, Regulatory Affairs, Global Patient Safety & Risk Management, Early Development, Program Management, Research, and Quality, plus external stakeholders.
- Serve as subject matter expert for Research & Development document strategy and production.
Qualifications:
- Bachelor’s degree in Life Science with relevant writing expertise, or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
- 10+ years of experience as a medical writer in sponsor/CRO settings (sponsor experience strongly preferred).
- Required: experience leading/planning/writing/coordinating/overseeing clinical dossiers for global regulatory filings (NDA/BLA/MAA). CTA/IND experience is a plus.
- 3+ years managing medical writing direct reports.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process.
- Track record managing multiple projects in a fast-paced, deadline-driven environment.
- Attention to detail; ability to complete assignments timely with minimal oversight.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.
- Demonstrated alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, Passion for Excellence.
- Lead Medical Writing efforts and strategy for drug development programs; ensure high-quality, on-time deliverables in compliance with regulations, Good Clinical Practices (GCP), and SOPs (including clinical protocols, amendments, investigator brochures, clinical study reports, biopharmaceutics summaries, clinical pharmacology, clinical safety/efficacy, clinical overviews, and related documents).
- Oversee, develop, and manage medical writers across multiple programs; provide leadership, coaching, guidance, mentorship; manage and train external writers/CROs.
- Communicate program goals and priorities to assigned medical writers.
- Plan, coordinate, oversee, and drive clinical filing dossiers with the Filing Excellence group.
- Independently plan, write, and edit high-quality, on-time writing deliverables as needed.
- Contribute to global department standards (templates, style guides, and processes) and implement process improvements.
- Collaborate with Medical Writing leadership to ensure appropriate planning and resourcing.
- Partner with Data Sciences & Statistics, Clinical Operations, Clinical Development, Regulatory Affairs, Global Patient Safety & Risk Management, Early Development, Program Management, Research, and Quality, plus external stakeholders.
- Serve as subject matter expert for Research & Development document strategy and production.
Qualifications:
- Bachelor’s degree in Life Science with relevant writing expertise, or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
- 10+ years of experience as a medical writer in sponsor/CRO settings (sponsor experience strongly preferred).
- Required: experience leading/planning/writing/coordinating/overseeing clinical dossiers for global regulatory filings (NDA/BLA/MAA). CTA/IND experience is a plus.
- 3+ years managing medical writing direct reports.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process.
- Track record managing multiple projects in a fast-paced, deadline-driven environment.
- Attention to detail; ability to complete assignments timely with minimal oversight.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.
- Demonstrated alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, Passion for Excellence.