Akima Intra-Data (AID), an Akima company, is not just another federal logistics services provider. As an Alaska Native Corporation (ANC), our mission and purpose extend beyond our exciting federal projects as we support our shareholder communities in Alaska. At AID, 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 United States. For our shareholders, AID provides support and employment opportunities and contributes to the survival of a culture that has thrived above the Arctic Circle for more than 10,000 years. For our government customers, AID delivers flexible, full-spectrum facilities, maintenance, and repair and logistics services that enable our customers to reduce operating costs, improve productivity, and enhance the value of their existing assets. As an AID 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 access to our comprehensive benefits and competitive pay in addition to growth opportunities and excellent retirement options.
SME - FOIA and Disclosure
Location
United States
Posted
1 day ago
Salary
$72 / hour
Seniority
Mid Level
No structured requirement data.
Job Description
SME - FOIA and Disclosure
Akima, LLC
Role Description AST is seeking a part-time highly experienced FOIA and Disclosure Subject Matter Expert (SME) to support our FDA CDER 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. Company Description Work Where it Matters Akima Secure Technologies (AST), an Akima company, is not just another federal facilities contractor. As an Alaska Native Corporation (ANC), our mission and purpose extend beyond our exciting federal projects 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 United States. - AST provides support and employment opportunities and contributes to the survival of a culture that has thrived above the Arctic Circle for more than 10,000 years. - AST’s capabilities provide agile, innovative, and trusted information technology solutions to achieve, maintain and advance functionality, efficiency, security, 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 access to our comprehensive benefits and competitive pay in addition to growth opportunities and excellent retirement options.
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