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Clinical Regulatory Expert - FDA Specialist

$130 - $170 par heure

Mercor

Toronto, ON
  • Travail à distance

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:

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

L'offre d'emploi a été publiée Il y a 2 mois
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