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 compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
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 are safe, and effective.
The Center for Drug Evaluation and Research (CDER), is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC). CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
The Office of Surveillance and Epidemiology (OSE) within the Center for Drug Evaluation and Research (CDER) works to detect, assess, prevent, and manage the risks of medications so that they can be relied upon to treat disease and improve health. All medicines have risks as well as benefits; the risks of medicines are the chances that something unwanted or unexpected could happen when consumers use them. OSE participates in the safety analysis of drugs before they are marketed to patients and consumers.
This position is in the Office of Medication Error Prevention and Risk Management (OMEPRM), in the Division of Mitigation Assessment and Medication Error Surveillance (DMAMES). The Division of Mitigation Assessment and Medication Error Surveillance (DMAMES) is responsible for reviewing risk evaluation and mitigation strategies (REMS) Assessment plans, methodologies and REMS assessment reports for all products with approved REMS.
Duties/Responsibilities
As the Supervisory Associate Director for Risk Evaluation and Mitigation Strategies, the incumbent serves as a senior advisor to Division Director and Deputy Director on complex scientific, administrative procedural, and policy issues that are related to the REMS assessments to support the Center’s policies related to REMS authorities under the Food and Drug Administration Amendments Act (FDAAA) of 2007. In this capacity, the incumbent provides critical leadership in short and long-term planning program development, policy and program analysis, and the implementation of REMS program initiatives and projects that support DMAMES and OMEPRM. The incumbent’s research identifies problems and issues in depth, carries out studies, consults with other professionals both within and outside the Office, and the Federal government as necessary.
- Provides supervisory oversight for REMS assessment activities conducted by clinicians and scientists in collaboration with others in Division leadership. Initiates decision making processes and documents, and participates in discussions and decisions concerning Division, Office, and Center plans programs, and activities related to REMS.
- Advises the DMAMES Director on methodologically challenging and/or controversial postmarketing safety issues. Concentrates on complex, long range, and emerging problems as applied to the programs for which the Division is responsible. Incumbent keeps fully abreast of the crucial and precedent setting REMS policies and practices pertinent to the Division and briefs senior leadership on all interpretations and evaluations when necessary.
- Provides authoritative resource on the review of REMS assessment and methods for conducting evaluations of drug safety-related issues and activities related to the REMS of medical products to Division and Office staff and other Center-wide programs. This responsibility requires close personal contact with the “state of science” to inculcate advancing theories and practices in the scientific field into the Division and Office programs.
- Provides critical guidance in the application of risk management principles, methods, and the research process of DMAMES’s drug safety regulatory research/investigation program. Advises Office staff about program evaluation approaches, methodologies, monitoring and contributes to developing guidance documents for Industry, including developing tools, processes, and best practices to improve the efficiency of the review of proposed REMS assessment plans, methodology, and assessment reports.
- Leads complex review programs, projects and processes relating to commitments under the user fee programs throughout the Office and coordination within CDER for meeting the commitments under PDUFA VII including modernization and improvement of REMS assessments. Responsibilities include analysis and resolution of complex issues to resolve difficult problems, operational changes, updates to guidance’s, policies and procedures, new review performance goals, and new performance review goals for REMS methodologies and Assessment reports.
- Serves as a subject matter expert, possessing scientific knowledge on different data systems utilizing both past and present, to monitor the effectiveness of different components of REMS which support the development of comprehensive REMS assessment plans. Responsible for maintaining knowledge on the procurement process sufficient to access fundable data systems and support the assessment process.
Supervisory Responsibilities: Provides occupational administrative direction and supervision 25% or more of the time to subordinate staff performing the work and functions of the organizational unit. Applies knowledge of administrative and program management principles and skills to carry out the mission of the Division as well as addressing and solving unusual and often precedent setting problems associated with Division programs. Seeks and develops the most cost effective and fiscally responsible methods to conduct these programs and to solve problems. Obtains resources and identifies strategic objectives for the organization.
How to Apply
Submit resume with cover letter by May 3, 2024 to: OSE-PMAS-Admin-Team@fda.hhs.gov. Resume may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
Please reference Job Reference ID: DMAMESSUPVAD0424
Announcement Contact
For questions regarding this Cures position, please contact OSE-PMAS-Admin-Team@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.