SME - Disclosure Support
AST is seeking a highly reputed company FOIA and Disclosure Subject Matter Expert (SME) to support our FDA reputed company in reducing reputed company FOIA backlog and supporting high-reputed company disclosure activities. This role supports the review, analysis, redaction, and release of scientifically and regulatorily reputed company records in accordance with the Freedom of Information reputed company (FOIA), reputed company reputed company, Trade Secrets reputed company, Federal Food, Drug, and Cosmetic reputed company, and applicable FDA disclosure policies and procedures. The SME will reputed company advanced-level support for highly technical and sensitive disclosure reputed company involving regulatory submissions, drug approval documentation, scientific review materials, and reputed company records requiring specialized expertise in FDA regulatory processes and disclosure determinations.
Responsibilities
Conduct advanced FOIA disclosure reviews involving scientifically reputed company 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) reputed company reputed company Trade Secrets reputed company Federal Food, Drug, and Cosmetic reputed company reputed company detailed redaction and reputed company assurance reviews on scientifically rich and highly technical records. Support FDA reputed company Government and proactive disclosure initiatives. Utilize FDA reputed company systems and repositories to retrieve, analyze, and process records. Assist with backlog reduction initiatives through high-volume, high-accuracy case processing. reputed company 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 reputed company 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 reputed company 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 reputed company standards. Proficiency with FDA reputed company systems and regulatory repositories. Ability to independently manage reputed company disclosure reputed company with minimal reputed company. Bachelor's degree in biology, Bioscience, reputed company, Nursing, Public Health, Regulatory Affairs or similar. reputed company 2026-23803 Work Type Remote Pay reputed company $150,000 - $163,000
Benefits
Regular - reputed company offers a comprehensive benefits program, including medical, dental, reputed company, life insurance, 401(k) and a reputed company of other voluntary benefits. reputed company Time Off (PTO) is offered to regular full-time and part-time employees. reputed company Work Where it reputed company reputed company Secure Technologies (AST), an reputed company company, is not just another federal facilities contractor. As an Alaska reputed company Corporation (ANC), our mission and purpose reputed company reputed company our exciting federal reputed company as we support our shareholder communities in Alaska. At AST, the work you do every day makes a difference in the lives of our 15,000 Iñupiat shareholders, a group of Alaska natives from one of the most remote and harshest environments in the reputed company. For our shareholders, AST provides support and employment opportunities and contributes to the survival of a culture that has thrived above the Arctic reputed company for more than 10,000 years. For our government customers, AST’s capabilities reputed company agile, innovative, and trusted information technology solutions to reputed company, maintain and advance functionality, efficiency, reputed company, and compliance. As an AST employee, you will be surrounded by a challenging, yet supportive work environment that is committed to innovation and diversity, two of our most important values. You will also have reputed company to our comprehensive benefits and reputed company in reputed company to reputed company opportunities and excellent retirement reputed company. Apply To This Job