Deputy 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.

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).

Duties/Responsibilities

As the Deputy Director for the Division of User Fee Management (DUFM), the incumbent assists the Director in providing leadership and oversight to the Immediate Office and 3 Branches. In this capacity, the incumbent supports the Director in meeting Division goals, securing and managing the resources necessary for Center for Drug Evaluation and Research (CDER) to execute its public health mission. through effective user fee program operations, reauthorization negotiations, budget planning, and financial management. The Deputy Director has direct oversight of the Immediate Office and serves as the alter ego for the Director in providing leadership and oversight to employees involved in managing collection of fee assessment activities for user fee programs (PDUFA, GDUFA, BsUFA, OMUFA and Compounding Quality Act) totaling $1.6 billion.

• Ensures that staff are hired, trained, supported, and evaluated properly to maximize the success of the Division. The Deputy Director interacts with a wide range of Offices throughout CDER, the Agency, and with portions of regulated industry to implement and execute the relevant user fee programs.

• Monitors incoming payments from regulated industry to ensure compliance with user fee statutes.

• Works with industry to address questions about user fee obligations.

• Prepares, supports, and participates in reauthorization negotiations.

• Provides input to determine annual user fees in PDUFA, GDUFA, BsUFA, CQA, and OMUFA.

Supervisory Responsibilities: Works with the Division Director leads a division compromised of 3 branches: Generics Branch, the Policy & Operations Branch, and the Brands Branch. Provides occupational specific technical and administrative direction and supervision 25 percent or more of the time to subordinate staff performing the work and functions of the organizational unit. Obtains resources, identifies strategic objectives, and establishes goals for the Division. Executes strategic objectives for the organization.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Desired Education: Our ideal candidate will possess a Master of Business Administration Degree and/or a Juris Doctor, preferred but not required.

Desired Professional Experience: Our ideal candidate will possess a minimum of 5 years of operations management experience in User Fee Management or related field.

Desired Professional Experience:

Our ideal candidate will possess:

• Ability to align and link administrative strategic plans and objectives to mission’s strategic plans.

• Knowledge and understanding of current FDA regulations, policies, and procedures.

• Ability to manage cross-functional teams, unite and engage staff for performance management; communicate and work toward organizational goals, and develop process improvements.

How to Apply

Submit resume or curriculum vitae with cover letter by July 10th, 2024, 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.”

Announcement Contact

For questions regarding this Cures position, please contact: CDER-OM-IO-AdminTeam@fda.hhs.gov.