Clinical Regulatory Expert - FDA Specialist
$130 - $170 per hourMercor
Toronto, ON
- Remote job
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:
- For any help or support, reach out to: Show email
PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.
Vacancy posted more than 2 months ago
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