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 C (GS-13 equivalent). The incumbent performs 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.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National
• Must meet basic qualification requirements: Degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines OR Combination of education and experience.
• In addition to basic requirements, must meet one of the following minimum years of experience requirements for Band C:
• Bachelor's degree and 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.
• Master's degree and 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.
• Doctorate degree and 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.
• MD/DO/DDS/DPM/DVM degree.
• Must submit all relevant transcripts that demonstrate required education.
• Must pass a security investigation.
• Must 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.
• Males born after December 31, 1959, must be registered with the Selective Service.

Nice To Haves

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

Responsibilities

• Performs the scientific disclosure analysis of the organization's most complex, sensitive, controversial, or precedent-sensitive records.
• Applies mastery of professional biological-science concepts and advanced knowledge of FDA regulatory science to interpret complex data and regulatory records.
• Resolves challenging questions concerning the application of FOIA exemptions, FDA disclosure regulations, confidentiality statutes, privacy protections, deliberative-process principles, and program-specific disclosure provisions.
• Develops authoritative recommendations for release, withholding, referral, consultation, and segregability of scientific records.
• Identifies the legal and scientific risks associated with alternative disclosure treatments.
• 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, and high-level information-sharing matters.
• 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.
• Analyzes new statutes, regulations, judicial decisions, and policy changes to determine their effect on scientific disclosure practices and recommends implementation approaches.
• Develops new or substantially revised decision frameworks, scientific-disclosure criteria, standard operating procedures, precedential analyses, or interpretive guidance.
• Serves as a senior consultant to FDA scientists, physicians, engineers, reviewers, compliance officials, managers, executives, disclosure officials, and attorneys on 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.

Benefits

• Career or career-conditional appointment
• Comprehensive benefits package
• Federal employee benefits (range of benefits designed to make your federal career very rewarding)
• 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

What This Job Offers

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