Remote FDA Regulatory Expert for AI Clinical Data

mercor; United States; Remote; USD 179,000 - 234,000; Part time

Job summary

Mercor is seeking a Contract Clinical Regulatory Expert to validate FDA documentation, respond to FDA information requests, and ensure regulatory data quality. The role emphasizes independent, asynchronous work across time zones, supporting AI research initiatives.

The candidate will bring 5+ years in regulatory roles, with MD/PhD/PharmD or equivalent, and must have no COI with a current federal employer. This contract requires 20–25 hours per week and remote collaboration.

Qualifications

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

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.

Skills

Regulatory affairs

FDA information requests

Clinical data review

Independent work

No COI with federal employer

Education

MD / PhD / PharmD or equivalent

Job description

Mercor is seeking a Contract Clinical Regulatory Expert to validate FDA documentation, respond to FDA information requests, and ensure regulatory data quality. The role emphasizes independent, asynchronous work across time zones, supporting AI research initiatives.

The candidate will bring 5+ years in regulatory roles, with MD/PhD/PharmD or equivalent, and must have no COI with a current federal employer. This contract requires 20–25 hours per week and remote collaboration.