Clinical Regulatory Expert - FDA Specialist

About the job

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.

Position: Clinical Regulatory Expert
Type:Contract
Compensation:$130–$170/hour
Location:Remote
Commitment:20–25 hours/week

Role 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.

Qualifications

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.

Application Process (Takes 20–30 mins to complete)

• Upload resume
• AI interview based on your resume
• Submit form

Resources & Support

• For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome
• For any help or support, reach out to: support@mercor.com

PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.