Associate Director, Medical Writing

The Opportunity

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.

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

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.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
• You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location