FOIA Disclosure Subject Matter Expert

Job Summary

To support the FDA CDER client in reducing complex FOIA backlog, the part-time FOIA and Disclosure Subject Matter Expert will conduct advanced reviews, analysis, redaction, and release of scientifically complex records in compliance with various disclosure laws and FDA policies while working remotely.

Key responsibilities

• Conduct advanced FOIA disclosure reviews involving scientifically complex and high-sensitivity FDA records
• Review and process regulatory submissions, including NDAs, BLAs, ANDAs, and pediatric review materials
• Perform detailed redaction and quality assurance reviews on highly technical records while supporting FDA Open Government initiatives

Required qualifications

• Minimum 10+ years of FDA FOIA/disclosure experience supporting regulatory and scientific records review
• Demonstrated expertise applying FOIA exemptions and disclosure statutes to complex scientific and regulatory records
• Strong understanding of the FDA drug development lifecycle and regulatory submissions
• Bachelor's degree in biology, bioscience, chemistry, nursing, public health, regulatory affairs, or a related field
• Proficiency with FDA enterprise systems and regulatory repositories