Associate Director, Medical Writing

Amylyx Pharmaceuticals • Cambridge, MA

2d • Remote

About The Position

Amylyx Pharmaceuticals is looking for an Associate Director, Regulatory Medical Writing who will work collaboratively cross-functionally to produce documents to support Amylyx development programs. This role requires a strategic thinker with a variety of experience in clinical development with deep insight into how different functions contribute to the success of the company.

Requirements

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level