Clinical Regulatory Expert

As a regulatory expert on this project, you would own a part in multiple workflows:

1. Clinical Data Generation: we need to validate that each data room and its documents hold up against FDA evidentiary standards and formatting expectations, including the deliberate defects planted to test regulatory judgment.

2. FDA RFI task authorship: you must be capable of authoring information requests and model responses, and designing prompts, golden outputs, and rubrics to quantify the ability of an AI agent attempting to do the same thing.

To be qualified for this role, you must fit the following requirements:

• Location: US, Canada, or France.

• YOE: 5+ required. 10-25 preferred.

• Education: MD, PhD, PharmD, or equivalent.

• Hourly availability: 20-25 hours/week, minimum. 30+ preferred.

• Experience: MUST have reviewed or responded to FDA information requests across CMC, patient-level data requests, investigator qualifications, and biomarker or endpoint evidence. Direct FDA review experience strongly preferred over sponsor-side liaison work. No conflict of interest with a current federal employer.

We consider all qualified applicants without regard to legally protected characteristics and provide reasonable accommodations upon request.

Contract and Payment Terms

• You will be engaged as an independent contractor.
• This is a fully remote role that can be completed on your own schedule.
• Projects can be extended, shortened, or concluded early depending on needs and performance.
• Your work at Mercor will not involve access to confidential or proprietary information from any employer, client, or institution.
• Payments are weekly on Stripe or Wise based on services rendered.
• Please note: We are unable to support H1-B or STEM OPT candidates at this time.

About Mercor

Mercor partners with leading AI labs and enterprises to train frontier models using human expertise. You will work on projects that focus on training and enhancing AI systems. You will be paid competitively, collaborate with leading researchers, and help shape the next generation of AI systems in your area of expertise.