FDA Regulatory Expert: Clinical Data & RFI Architect
Obsidian
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. #J-18808-Ljbffr Obsidian
Vacancy posted 2 days ago
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