Associate Director, Medical Writing

Amylyx Pharmaceuticals is looking for an Associate Director, Regulatory Medical Writing to work collaboratively cross-functionally to produce documents to support Amylyx development programs.

Requirements

• Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years
• Strong knowledge of FDA/ICH guidelines, GCP and eCTD
• 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