Amylyx Pharmaceuticals · 19 hours ago
Associate Director, Medical Writing
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$179K/yr - $201K/yr
5+ years expAmylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. They are seeking an Associate Director of Regulatory Medical Writing to produce critical documents supporting development programs and to collaborate cross-functionally within the organization.
BiotechnologyMedicalNeurosciencePharmaceutical
Responsibilities
Work with internal and external subject experts to plan, prepare, edit, and finalize protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, meeting briefing books, etc.)
Manage the internal review process, including internal and external technical review, while driving sign-off timelines
Collate materials, both internal and external, and ensure that documents using these materials accurately and concisely reflect appropriate sources of information
Manage Amylyx-standard templates, in accordance with ICH and regulatory guidelines. Implement appropriate document QC procedures in accordance with Amylyx Quality Guidelines
Manage vendors and contractors for production of documents when necessary
Qualification
Required
Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years. Relevant career experience includes managing and producing clinical and regulatory documents
Strong knowledge of FDA/ICH guidelines, GCP and eCTD
Provide leadership and management for complex documentation projects
Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
Experience in coordination and prioritization of multiple projects in a fast-paced environment
Must have proven ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users
Fluent in English (oral and written communication) skills
Awareness of pharmaceutical industry needs beyond clinical development and medical affairs
Company
Amylyx Pharmaceuticals
Amylyx Pharmaceuticals specializes in providing solutions for Alzheimer’s and other diseases of the brain.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$623.45MKey Investors
Viking Global InvestorsMorningside
2025-09-10Post Ipo Equity· $175M
2022-10-06Post Ipo Equity· $246.3M
2022-01-07IPO
Leadership Team
Jim Frates
Chief Financial Officer
Camille Bedrosian
Chief Medical Officer
Recent News
BioWorld Financial Watch
2026-01-11
Longevity.Technology
2026-01-11
Company data provided by crunchbase