Clinical Regulatory Expert: FDA RFI & Data Validation

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

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.