Trial Master File Manager (Biotech / Oncology)
Exelixis(5 days ago)
About this role
The TMF Manager supports operational activities related to Trial Master Files to ensure they meet compliance standards and are inspection ready. They serve as a subject matter expert, oversee study closures, and collaborate across functions to improve processes and maintain industry and regulatory compliance.
Required Skills
- TRMF Management
- GCP
- Regulatory Compliance
- Project Management
- Quality Control
- Electronic Records
- Document Management
- SOPs
- Metrics Analysis
- Clinical Trials
Qualifications
- BS/BA or MS/MA in related discipline
- 7+ years' experience in pharmaceutical or regulated environment
- Experience with electronic records management systems
- Knowledge of FDA and other regulations
About Exelixis
exelixis.comExelixis is an oncology-focused biotech company innovating cancer treatments for life. Find out how we're dedicated to giving more patients hope for the future.
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