Role OverviewAs a Clinical Regulatory Expert, you will validate clinical data rooms and documents against FDA evidentiary standards, design prompts and rubrics for AI agent capabilities, and ensure compliance with regulatory judgment. You will work independently and asynchronously to meet deadlines and improve AI model performance. This role is a contract position, working 20-25 hours/week.
What You Will Do
Your main responsibilities will include validating clinical data rooms and documents, authoring FDA information requests and model responses, designing prompts and rubrics, and ensuring compliance with regulatory judgment.
Why It Might Be a Fit
We are looking for a candidate with 5+ years of experience in regulatory roles, an MD, PhD, PharmD, or equivalent, and experience reviewing or responding to FDA information requests. You will work independently and asynchronously to meet deadlines and improve AI model performance.
Requirements
- 5+ years of experience in regulatory roles
- MD, PhD, PharmD, or equivalent
- Experience reviewing or responding to FDA information requests across CMC, patient-level data, investigator qualifications, and biomarker or endpoint evidence
- No conflict of interest with a current federal employer
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