Clinical Regulatory Expert - FDA Specialist

Job Description

Job Description

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

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• For any help or support, reach out to: View email address on ziprecruiter.com

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