Clinical Regulatory Expert - FDA Specialist

Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey.

Responsibilities

• Validate clinical data rooms and documents against FDA evidentiary standards and formatting expectations.
• Author FDA information requests and model responses.
• Design prompts, golden outputs, and rubrics to quantify AI agent capabilities.
• Ensure compliance with deliberate defects testing regulatory judgment.
• Work independently and asynchronously to meet deadlines and improve AI model performance.

Requirements

Must-Have

• 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.

Preferred

• 10–25 years of experience.
• Direct FDA review experience preferred over sponsor-side liaison work.

Pay

$130–$170/hour

Schedule

20–25 hours/week, remote