[Hiring] SME - Disclosure Support @Akima, LLC

Role Description

AST is seeking a highly experienced FOIA and Disclosure Subject Matter Expert (SME) to support our FDA client in reducing complex FOIA backlog and supporting high-priority disclosure activities. This role supports the review, analysis, redaction, and release of scientifically and regulatorily complex records in accordance with the Freedom of Information Act (FOIA), Privacy Act, Trade Secrets Act, Federal Food, Drug, and Cosmetic Act, and applicable FDA disclosure policies and procedures.

The SME will provide advanced-level support for highly technical and sensitive disclosure matters involving regulatory submissions, drug approval documentation, scientific review materials, and related records requiring specialized expertise in FDA regulatory processes and disclosure determinations.

• Conduct advanced FOIA disclosure reviews involving scientifically complex and high-sensitivity FDA records.
• Review and process regulatory submissions and supporting documentation, including:
  • NDAs (New Drug Applications)
  • BLAs (Biologics License Applications)
  • ANDAs (Abbreviated New Drug Applications)
  • NME and non-NME approval packages
  • Pediatric review materials (BPCA/PREA)
• Analyze records for releasability and apply appropriate exemptions under:
  • FOIA (5 U.S.C. § 552)
  • Privacy Act
  • Trade Secrets Act
  • Federal Food, Drug, and Cosmetic Act
• Perform detailed redaction and quality assurance reviews on scientifically rich and highly technical records.
• Support FDA Open Government and proactive disclosure initiatives.
• Utilize FDA enterprise systems and repositories to retrieve, analyze, and process records.
• Assist with backlog reduction initiatives through high-volume, high-accuracy case processing.
• Provide technical guidance and mentorship to FOIA analysts and review staff to promote consistency and compliance in disclosure determinations.
• Coordinate with FDA stakeholders, disclosure staff, and legal/policy personnel as needed to resolve complex disclosure issues.

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 FDA drug development lifecycle, regulatory submissions, and approval processes.
• Experience processing highly technical disclosure packages involving pharmaceutical and biologic products.
• Demonstrated experience conducting high-volume disclosure reviews while maintaining exceptional quality standards.
• Proficiency with FDA enterprise systems and regulatory repositories.
• Ability to independently manage complex disclosure matters with minimal oversight.
• Bachelor's degree in biology, Bioscience, Chemistry, Nursing, Public Health, Regulatory Affairs or similar.

Benefits

• The company offers a comprehensive benefits program, including medical, dental, vision, life insurance, 401(k) and a range of other voluntary benefits.
• Paid Time Off (PTO) is offered to regular full-time and part-time employees.