Senior Regulatory Advisor
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Job Summary
Providing senior-level regulatory and scientific guidance, the part-time PRN Senior Regulatory Advisor will advise on FDA regulations, perform clinical reviews, and assist in clinical trial design and analysis while working remotely with a commitment of approximately 5 hours per week.
Key responsibilities
- Provide guidance on FDA regulations and clinical research requirements
- Perform clinical reviews and advise on findings related to clinical trials
- Participate in Scientific Leadership Team meetings to evaluate new opportunities and advise on trial design
Required qualifications
- Medical degree (MD) or equivalent advanced scientific degree
- Extensive senior-level experience in clinical research and regulatory affairs
- Demonstrated experience with FDA guidance and clinical reviews
- Strong background in clinical trial design, conduct, and data analysis
- Experience evaluating new development opportunities preferred
Complete Job Description
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