Science Disclosure Analyst

Food and Drug Administration • Silver Spring, MD

1d

About The Position

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). The analyst will independently conduct 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. This involves integrating 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. The role also evaluates how disclosure of one portion of a record may reveal protected information contained elsewhere in the record or submission. The analyst will apply 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. The position 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. Disclosure analyses are conducted 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. Quality assurance and quality control methods are applied to determine risk and compliance standards for work and associated risk mitigation actions are implemented. The role 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. The analyst analyzes changes in disclosure statutes, regulations, judicial decisions, Department of Justice guidance, or FDA policy and assesses their effect on established scientific-disclosure practices. Inconsistencies or gaps in existing disclosure practice are identified, and recommendations for clarifications, decision rules, or procedural changes are made to promote uniform treatment of comparable scientific information. The position 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. Disclosure consultations and referrals are coordinated with other FDA components, HHS, other Federal agencies, and information submitters when necessary to establish the factual basis for a disclosure decision. Standard operating procedures, job aids, decision matrices, scientific-disclosure examples, training materials, or reference resources are developed or substantially revised based on changes in law, policy, scientific practice, or recurring case issues. Training courses are conducted for Center staff on FOIA, Privacy Act, and implementing regulations, providing appropriate written instructions and guidelines.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring. Appointment to the position will be contingent upon a negative applicant drug test result.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
• Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
• 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.
• 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.
• 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.
• Have a MD/DO/DDS/DPM/DVM degree.
• Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
• 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.
• If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
• If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
• 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.

Nice To Haves

• Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply.

Responsibilities

• 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.

Benefits

• A career with the U.S. government provides employees with a comprehensive benefits package.
• As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.
• Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent.
• Contact the hiring agency for more information on the specific benefits offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level