Regulatory Scientific Subject Matter Expert
Job Summary
Providing domain-level expertise, the full-time Subject Matter Expert - Regulatory / Scientific will validate, design, and enrich specialized training curricula for FDA regulatory reviewers and scientific personnel in a remote setting with periodic on-site presence in Silver Spring, MD.
Key responsibilities
- Ensure technical accuracy, regulatory defense, and scientific validity of training programs for FDA staff
- Collaborate with Instructional Systems Designers to develop practical case studies and training modules
- Review and validate scientifically sound courseware and practical exercises in partnership with instructional design teams
Required qualifications
- Minimum of seven (7) years of professional experience in a regulatory, scientific, or technical role
- Advanced degree (Master's or Ph.D.) in a relevant scientific, medical, regulatory, or technical discipline
- Deep understanding of regulatory review processes and decision-making frameworks
- Proven experience in collaborating with instructional design teams for curriculum development
- Familiarity with continuing education and professional credentialing for scientific and healthcare professionals preferred
Complete Job Description
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