Remote Clinical Regulatory Expert — FDA & AI Data

mercor; San Francisco (CA); Hybrid; CAD 255,000 - 334,000; Part time

Job summary

Mercor is seeking a Clinical Regulatory Expert for a remote contract role. The position averages 20–25 hours per week at $130–$170 per hour.

Key responsibilities include validating clinical data against FDA standards, drafting FDA information requests and model responses, and designing prompts to measure AI capabilities. This is a flexible, independently managed engagement designed for experienced regulatory professionals.

Qualifications

• 5+ years of regulatory experience.
• Experience reviewing FDA information requests across CMC, patient data, investigator qualifications, and endpoints.
• No current federal employer conflict.
• Preferred: 10–25 years of experience.
• Direct FDA review experience preferred over sponsor liaison.

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 expertise

FDA information requests handling

Independent work

Education

MD / PhD / PharmD / or equivalent

Job description

Mercor is seeking a Clinical Regulatory Expert for a remote contract role. The position averages 20–25 hours per week at $130–$170 per hour.

Key responsibilities include validating clinical data against FDA standards, drafting FDA information requests and model responses, and designing prompts to measure AI capabilities. This is a flexible, independently managed engagement designed for experienced regulatory professionals.