Associate Director, Medical Writing
Amylyx Pharmaceuticals
5 hours ago
Remote
United States
$179,000 - $201,000 USD yearly
Clinical Research and Development
Associate Director, Regulatory Medical Writing
Responsibilities:
- Work with internal and external subject experts to plan, prepare, edit, and finalize protocols, investigator brochures, synopses, clinical study reports, and regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, meeting briefing books, etc.).
- Manage internal review processes (internal/external technical review) and drive sign-off timelines.
- Collate internal/external materials and ensure documents accurately and concisely reflect source information.
- Manage Amylyx-standard templates in accordance with ICH and regulatory guidelines; implement document QC procedures per Amylyx Quality Guidelines.
- Manage vendors and contractors for document production when necessary.
Requirements:
- Bachelor’s degree with 10+ years; or MS with 8+ years; or PhD with 5+ years; experience managing and producing clinical and regulatory documents.
- Strong knowledge of FDA/ICH guidelines, GCP, and eCTD.
- Leadership and management for complex documentation projects.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems; familiarity with SharePoint and structured content management concepts.
- Experience coordinating/prioritizing multiple projects in a fast-paced environment.
- Proven ability to interpret clinical trial output and summarize results clearly and scientifically accurately.
- Fluent English (oral and written).
- Awareness of pharmaceutical industry needs beyond clinical development and medical affairs.
Compensation:
- Estimated pay range: $179,000–$201,000 USD.
Application instructions (as provided):
- To return to the website please click here.
Responsibilities:
- Work with internal and external subject experts to plan, prepare, edit, and finalize protocols, investigator brochures, synopses, clinical study reports, and regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, meeting briefing books, etc.).
- Manage internal review processes (internal/external technical review) and drive sign-off timelines.
- Collate internal/external materials and ensure documents accurately and concisely reflect source information.
- Manage Amylyx-standard templates in accordance with ICH and regulatory guidelines; implement document QC procedures per Amylyx Quality Guidelines.
- Manage vendors and contractors for document production when necessary.
Requirements:
- Bachelor’s degree with 10+ years; or MS with 8+ years; or PhD with 5+ years; experience managing and producing clinical and regulatory documents.
- Strong knowledge of FDA/ICH guidelines, GCP, and eCTD.
- Leadership and management for complex documentation projects.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems; familiarity with SharePoint and structured content management concepts.
- Experience coordinating/prioritizing multiple projects in a fast-paced environment.
- Proven ability to interpret clinical trial output and summarize results clearly and scientifically accurately.
- Fluent English (oral and written).
- Awareness of pharmaceutical industry needs beyond clinical development and medical affairs.
Compensation:
- Estimated pay range: $179,000–$201,000 USD.
Application instructions (as provided):
- To return to the website please click here.