Related skills
gcp microsoft office document management sharepoint ich📋 Description
- Plan, edit, and finalize protocols, briefs, synopses, and regulatory documents.
- Manage internal and external reviews, driving sign-off timelines.
- Collate materials and ensure documents reflect sources accurately.
- Manage templates per ICH/regulatory guidelines; implement QC procedures.
- Coordinate vendors/contractors for document production when needed.
🎯 Requirements
- Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years in a relevant field.
- Strong knowledge of FDA/ICH guidelines, GCP and eCTD.
- Provide leadership for complex documentation projects.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and SharePoint.
- Experience coordinating multiple projects in a fast-paced environment.
- Must have proven ability to understand and interpret clinical trial output; summarize results clearly for end users.
🎁 Benefits
- Remote work opportunities in the United States
- Travel to Cambridge, MA several times per year
- Join a mission-driven clinical-stage company
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