Science Disclosure Analyst

Summary

This 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).

Duties

Independently 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. Qualifications

In 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.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. Please follow all instructions carefully. Errors or omissions may affect your eligibility. Other Information

The application limit, if applicable, for this advertisement is: 150 applications This position has promotion potential to the Band C level (GS-13 equivalent). Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: No License required: No Mobility agreement required: No Immunization required: No Bargaining Unit: No Telework eligible position: Telework is at the discretion of the supervisor. This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Additional Information: Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. If you are serving, or have served in the last 5 years (from 10/14/2026) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring. Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply. If selected, officers may either (1) remain on active duty assigned to the designated billet for PHS assignment, or (2) separate or retire from the Commissioned Corps before entering a Title 21 civilian appointment. All requirements must be met by the closing date of this announcement (10/14/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.