Division Director, Division Of User Fee Management
This position is being filled under a stream‐lined hiring authority, Title 21, Section 3072 of the
21st Century Cures Act. The candidate selected for this position will serve under a career or
career‐conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
To view the full vacancy announcement, click here: https://www.fda.gov/media/165128/download
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Management to provide trusted, timely management information and services with our diverse, empowered workforce of professionals who enable the Center for Drug Evaluation and Research to achieve its public health goals and objectives.
The Division of User Fee Management (DUFM) obtains the resources necessary for the Center and Agency to achieve their mission of promoting and protecting public health. DUFM does this by providing central oversight and management of CDER’s user fee programs, including the Prescription Drug User Fee Amendments (PDUFA), the Biosimilar User Fee Amendments (BsUFA), the Generic Drug User Fee Amendments (GDUFA), the Compounding Quality Act (CQA), and the Over-the-Counter Monograph User Fee Program (referred to as OMUFA).
As the Director for the Division of User Fee Management (DUFM), the incumbent operates as a senior level manager providing leadership, oversight, and execution of responsibilities to obtain the resources necessary for the Center and Agency to achieve their mission of promoting and protecting public health. The incumbent provides central oversight and management of CDER’s user fee programs, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Act (BsUFA), the Compounding Quality Act (CQA), and the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The Director coordinates and manages the financial and resource management and operational planning for user fee programs totaling $1.8 billion.
Manages the collection and fee assessment activities for user fee programs and the collaboration with a wide range of Offices throughout CDER, the Agency, and portions of regulated industry to implement and execute operational aspects and high-level decisions of user fee programs used in CDER. The Director provides leadership and direction to subordinate Branch Chiefs and other staff responsible for the following activities:
· Monitoring incoming payments from regulated industry to ensure compliance with user fee statutes.
· Working with industry to address questions about user fee obligations.
· Preparing for, supporting, and participating in reauthorization negotiations.
· Providing input to determine annual user fees in PDUFA, GDUFA, BsUFA, CQA, and OMUFA.
Serves as an advisor to the Office of Management (OM) Director and Deputy Director providing authoritive guidance and recommendations on analyzing and determining budget trends and funding levels for Center’s user fee programs and activities. Oversees the establishment of program strategic goals, structure, and processes necessary to implement the organization’s mission and vision of the user fee programs and operational needs of the Center. Manages the assessment of program feasibility by formulating short-and long-term goals; structuring and organizing work; setting priorities; anticipating, identifying, diagnosing, and consulting on potential problems areas; establishing management standards; and utilizing procedures and processes to monitor progress toward organization objectives.
Supervisory Responsibilities: Leads and directs a Division comprised of 65 full time equivalents that includes subordinate supervisors and skilled technical staff. Ensures that staff are hired, trained, supported, and evaluated properly to maximize the success of the Division. Defines jobs, selects employees, and assigns work; defines technical work requirements and milestones; evaluates the organization and employee accomplishments by accepting or rejecting work products; and presents and defends the organization’s work to senior management and other offices. Recommends employee promotions and recognition; approves leave; implements performance modifications; and takes corrective actions as appropriate.
How to Apply
How to Apply: Submit resume or curriculum vitae with cover letter by February 16, 2023 to: Roland Reynolds at Roland.Reynolds@fda.hhs.gov. Candidate resumes may be shared with hiring official within the CDER/OM with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share.” For questions, please contact Roland Reynolds at Roland.Reynolds@fda.hhs.gov.
For questions regarding this Cures position, please contact: CDER-OM-IO-AdminTeam@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.