About this role
Job SummaryThis position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent).
QualificationsIn order to qualify for the Science Disclosure Analyst position which falls under the 0401 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/14/2026: Basic Qualification Requirements: A. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. OR B. Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS FOR THE BAND B. 1. Have a bachelor's degree and also have three (3) years of comparable experience providing advice to stakeholders regarding scientific policies and procedures to address emerging issues related to scientific work; using scientific knowledge to implement and ensure compliance of statutory or other requirements for highly technical scientific information; and using scientific information relevant to drugs and/or biological products. OR 2. Have a master's degree and also have two (2) years of comparable experience providing advice to stakeholders regarding scientific policies and procedures to address emerging issues related to scientific work; using scientific knowledge to implement and ensure compliance of statutory or other requirements for highly technical scientific information; and using scientific information relevant to drugs and/or biological products. OR 3. Have a doctorate degree and also have one (1) year of comparable experience providing advice to stakeholders regarding scientific policies and procedures to address emerging issues related to scientific work; using scientific knowledge to implement and ensure compliance of statutory or other requirements for highly technical scientific information; and using scientific information relevant to drugs and/or biological products. OR 4. Have a MD/DO/DDS/DPM/DVM degree. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Major DutiesIndependently conducts comprehensive disclosure analysis of complex, sensitive, and high-volume scientific and regulatory records involving FDA-regulated products, programs, research, inspections, submissions, applications, scientific reviews, clinical or laboratory information, and related agency records. Integrates professional scientific knowledge with regulatory context to determine whether individual passages, data elements, analyses, methods, findings, and related information are releasable, subject to protection, or require consultation. Evaluates how disclosure of one portion of a record may reveal protected information contained elsewhere in the record or submission. Applies FOIA exemptions and other disclosure restrictions to scientifically dense records, including questions involving confidential commercial information, trade secrets, personal privacy, pre-decisional or deliberative information, investigatory or enforcement-sensitive information, and information protected by specific statutes. Makes independent proposed releasability determinations within delegated parameters; prepares redacted/releasable records; ensures segregability; and develops complete documentation supporting release, withholding, referral, and consultation decisions. Conducts disclosure analyses for proactive publication, advisory committee materials, scientific-information sharing with domestic or international counterparts, and other authorized disclosure activities, adapting the review to the governing disclosure mechanism. Applies quality assurance and quality control methods to determine risk and compliance standards for work and implements associated risk mitigation actions. Develops well-supported recommendations for denials or partial denials and prepares scientific and factual analyses that allow authorized denial officials and counsel to evaluate the basis for withholding. Analyzes changes in disclosure statutes, regulations, judicial decisions, Department of Justice guidance, or FDA policy and assesses their effect on established scientific-disclosure practices. Identifies inconsistencies or gaps in existing disclosure practice and recommends clarifications, decision rules, or procedural changes to promote uniform treatment of comparable scientific information. Serves as a scientific-disclosure consultant to FDA program offices, coordinating with scientists, physicians, engineers, reviewers, compliance personnel, product specialists, records custodians, and managers to resolve difficult questions concerning the scientific meaning and releasability of information. Coordinates disclosure consultations and referrals with other FDA components, HHS, other Federal agencies, and information submitters when necessary to establish the factual basis for a disclosure decision. Develops or substantially revises standard operating procedures, job aids, decision matrices, scientific-disclosure examples, training materials, or reference resources based on changes in law, policy, scientific practice, or recurring case issues. Conducts training courses for Center staff on FOIA, Privacy Act, and implementing regulations, providing appropriate written instructions and guidelines.