FDA Regulatory Expert: Clinical Data & RFI Architect

Obsidian; New York (NY); On-site; USD 96,000 - 165,000; Part time

Job summary

Obsidian is seeking a regulatory expert to own a segment of workflows including Clinical Data Generation and FDA RFI task authorship. You will validate data rooms against FDA standards and craft prompts, rubrics, and model outputs for RFIs and related documents.

Ideal candidates hold MD/PhD/PharmD with 5+ years of experience reviewing FDA information requests across CMC and biomarker evidence, and have no COI with a federal employer. Availability is 20–25 hours/week, with 30+ preferred.

Qualifications

• Must have reviewed 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.

Responsibilities

• Own a part in multiple workflows: Clinical Data Generation validation against FDA standards and formatting expectations.
• Author FDA information requests and model responses; design prompts, golden outputs, and rubrics to quantify AI performance.

Skills

FDA experience

Regulatory expertise

Data validation

Clinical data handling

RFI design

Education

MD/PhD/PharmD

Job description

Obsidian is seeking a regulatory expert to own a segment of workflows including Clinical Data Generation and FDA RFI task authorship. You will validate data rooms against FDA standards and craft prompts, rubrics, and model outputs for RFIs and related documents.

Ideal candidates hold MD/PhD/PharmD with 5+ years of experience reviewing FDA information requests across CMC and biomarker evidence, and have no COI with a federal employer. Availability is 20–25 hours/week, with 30+ preferred.