Clinical Regulatory Expert

Great Value Hiring; France; Sur place; EUR 154 000 - 202 000; Temps partiel

Résumé du poste

Great Value Hiring seeks a Clinical Regulatory Expert to own parts of regulatory workflows, including clinical data validation and FDA RFI tasks. This role requires an MD, PhD, PharmD, or equivalent, 5+ years of experience (10–25 preferred), and 20–25 hours per week (30+ preferred).

Location options include US/Canada/France. Candidates must have reviewed FDA information requests across CMC, patient data requests, biomarkers or endpoints, with no current federal conflicts.

Qualifications

• MD, PhD, PharmD, or equivalent.
• 5+ years of regulatory experience (10–25 preferred).
• Available 20–25 hours per week (30+ preferred).

Responsabilités

• Own part in multiple regulatory workflows: Clinical Data Generation validation and FDA RFI task design.
• Author FDA information requests and model responses, prompts, golden outputs, and rubrics to quantify AI agent performance.

Description du poste

Clinical Regulatory Expert [$130-$170/hr]

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

• 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.
• 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.