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 C (GS-13 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 C. 1. Have a bachelor's degree and also have four (4) 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 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 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 DutiesPerforms the scientific disclosure analysis of the organization's most complex, sensitive, controversial, or precedent-sensitive records, including matters involving novel science, emerging technologies, major regulatory actions, significant commercial interests, substantial public attention, or litigation risk. Applies mastery of professional biological-science concepts and advanced knowledge of FDA regulatory science to interpret the context, significance, and interdependence of complex data, analyses, methods, conclusions, and regulatory records before determining their disclosure treatment. Resolves challenging questions concerning the application of FOIA exemptions, FDA disclosure regulations, confidentiality statutes, privacy protections, deliberative-process principles, and program-specific disclosure provisions to advanced scientific records where precedent is limited, conflicting, or evolving. Develops authoritative recommendations for release, withholding, referral, consultation, and segregability; identifies the legal and scientific risks associated with alternative treatments; and prepares decision-ready documentation for senior disclosure officials, executives, or counsel. Directs or coordinates scientific disclosure review for major proactive-disclosure initiatives, advisory committee records, high-level information-sharing matters, or other significant disclosure activities that require consistent treatment across large record sets or multiple organizational components. Tracks, monitors, follows up, analyzes, completes, and clears important and sensitive Office responses to FOIA requests and other requests for scientific disclosure analysis. Reviews and analyzes appeals from disclosure denials and recommends final FDA decisions for supervisor concurrence. Analyzes new statutes, regulations, judicial decisions, Department of Justice guidance, HHS policy, FDA policy, and changes in regulatory science to determine their effect on scientific disclosure practices and recommends agency or organizational implementation approaches. Develops new or substantially revised decision frameworks, scientific-disclosure criteria, standard operating procedures, precedential analyses, or interpretive guidance when existing rules or examples are inadequate for recurring or high-risk scientific records. Serves as a senior consultant to FDA scientists, physicians, engineers, reviewers, compliance officials, managers, executives, disclosure officials, and attorneys on the treatment of complex scientific information under disclosure and confidentiality requirements. Briefs senior management on high-impact disclosure issues, precedent implications, scientific considerations, litigation or reputational risks, and recommended courses of action; represents the organization on cross-functional working groups or special initiatives involving scientific information disclosure. Develops advanced training, decision tools, knowledge repositories, precedent summaries, and quality-control methods for scientific disclosure analysis. Mentors and provides technical guidance to other analysts and staff on scientific analysis, disclosure methodology, precedent, and complex case strategy without performing supervisory functions.