Regulatory Scientific Reviewer (Epidemiologist)

Full Job Description

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 2, Band D.

In order to qualify for the Regulatory Scientific Reviewer (Epidemiologist) position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: Minimum Qualifications Requirements: A.

Must have a bachelor's degree or higher in epidemiology, medical, economics, statistics, pharmacology, or public health. The degree must be from an accredited program or institution. OR B.

Must have comparable experience conducting epidemiological reviews of sponsor protocols and study reports, planning and executing epidemiological research on FDA-regulated products, and providing expert consultant services through all phases of study development from research question specification and study design selection to data analysis using appropriate statistical techniques and integration of findings into regulatory decision-making processes.

AND Minimum Experience and/or Education Requirements A.

Have a Bachelor's degree and also have 5 years of comparable experience providing technical leadership and guidance in a critical assignment area of major importance to the regulated industry, such as a specific product class, regulatory process, or scientific discipline; establishing objectives, determining methodological approaches, and planning, scheduling, and executing all aspects of regulatory assignments.

B.

Have a Master's degree and also have 4 years of comparable experience providing technical leadership and guidance in a critical assignment area of major importance to the regulated industry, such as a specific product class, regulatory process, or scientific discipline; establishing objectives, determining methodological approaches, and planning, scheduling, and executing all aspects of regulatory assignments.

C.

Have a Doctorate/or JD degree and also have 2 years of comparable experience providing technical leadership and guidance in a critical assignment area of major importance to the regulated industry, such as a specific product class, regulatory process, or scientific discipline; establishing objectives, determining methodological approaches, and planning, scheduling, and executing all aspects of regulatory assignments.

D.

Have a MD/DO/DDS/DPM/DVM degree and also have 2 years of comparable experience providing technical leadership and guidance in a critical assignment area of major importance to the regulated industry, such as a specific product class, regulatory process, or scientific discipline; establishing objectives, determining methodological approaches, and planning, scheduling, and executing all aspects of regulatory assignments.

E.

Have seven (7) years of comparable experience providing technical leadership and guidance in a critical assignment area of major importance to the regulated industry, such as a specific product class, regulatory process, or scientific discipline, establishing objectives, determining methodological approaches, and planning, scheduling, and executing all aspects of regulatory assignments.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Major Duties:

Plan and schedule work activities while maintaining alignment with broader FDA regulatory programs and priorities.

Coordinate activities across multiple stakeholders and integrate diverse perspectives to achieve regulatory objectives.

Advise on area-specific research initiatives, product-specific inspections, and product release responsibilities.

Coordinate assignments with internal and external stakeholders, including industry, academia, and other government agencies.

Coordinate and participate in hearings as required in connection with assigned responsibilities.

Develop scientific review guidelines, rules, and approval criteria for product classes leading to publication in the Federal Register.