Title 21: 21st Century Cures Act Positions
The 21st Century Cures Act was enacted on December 13, 2016 and Section 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FY23 Food and Drug Omnibus Reform Act expanded this authority further amending Title 21 to include cross-cutting operational positions and individuals that support the development review and regulation of food and cosmetics in addition medical products. (codified into Title 21 of the United States Code (21 US Code 379d-3a).
The positions listed below are being filled under Title 21. The candidate selected for these positions will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here
Title 21 Open Vacancies
Deputy Commissioner for Human Foods
The Office of the Commissioner is recruiting for a Deputy Commissioner for Human Foods to report directly to the Commissioner and serve as a clear line of authority over the entire Human Foods portfolio which presently include the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy & Response, and certain human foods-related components of the Office of Regulatory Affairs (ORA).
Lead Mathematical Statistician
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for a Lead Mathematical Statistician. As the Lead Mathematical Statistician, the incumbent will work with the Division Director and Deputy Director to engage in statistical review and policy activities as well as special projects.
Regulatory Policy Analyst (OP)
The Center for Devices and Radiological Health (CDRH), Office of Policy (OP) is recruiting for a Regulatory Policy Analyst. Reporting directly to the Deputy Director, the Regulatory Policy Analyst will be responsible for: drafting supporting statements for information collection requests as required per the Paperwork Reduction Act (PRA) for regulations, guidance documents and/or other requests for information (e.g., surveys), and collaborative document development within the center, specifically for medical devices and radiological health products; leading work groups to accomplish these responsibilities and objectives; coordinating with other Centers and Offices within the FDA; and analyzing public comments on such regulatory documents which could have PRA implications and implementing appropriate revisions to documents.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for an Interdisciplinary Scientist. As an Interdisciplinary Scientist, the incumbent serves as a technical reviewer evaluating and conducting inspections of nonclinical laboratory studies (GLP studies) and the clinical and bioanalytical portions of bioavailability and bioequivalence studies supporting new and generic drug submissions to the FDA to help ensure the health and welfare of research participants, the reliability of study data, and compliance with United States laws and regulations, in support of protecting the public health.
Pharmacist
The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) is recruiting a Pharmacist. As a Pharmacist, within the Immediate Office, Office of Regulatory (ORP), the incumbent provides leadership and scientific knowledge to the areas of pharmacy practice and regulatory issues as they relate to the Food, Drug, and Cosmetic Act, the Public Health Service Act, the Paperwork Reduction Act, the Drug Price Competition and Patent Term Restoration Act, the Generic Animal Drug and Patent Term Restoration Act, and the Leahy‐Smith America Invents Act Serving as a scientific member of a multidisciplinary team of professionals, the incumbent is responsible for reviewing a wide range of related issues within the Office and across the Center, and for participating in a range of functions related to implementing patent term restoration provisions.
Director, Division of User Fee Management
The Center for Drug Evaluation and Research (CDER), Office of Management (OM) is recruiting for a Director, Division of User Fee Management. 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.
Business Informatics Specialist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Business Informatics Specialist. As a Business Informatics Specialist, the incumbent performs a variety of complex activities to include business analysis, project management, communication to understand and document business needs, develop strategies to meet those needs, and execute informatics projects.
Computer Scientist (Band A/B/C levels) (Remote)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Computer Scientist. As a Computer Scientist, the incumbent works to meet mission-critical informatics initiatives in support of CDER’s regulatory operations by assisting in the development of software systems that form the basis of the modern computing environment for scientific review of human drugs and therapeutic biologics.
Deputy Division Director - OPEQ/OCEA/DCEA3
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence & Analysis (OCEA), Division of Clinical Evidence and Analysis 3 (DCEA3) is recruiting for a Deputy Division Director. The incumbent will assist the DCEA 3 Director in setting strategy, advancing initiatives, and ensuring the goals, priorities, and objectives of the Division align with those of OCEA, OPEQ, and the Center.
Pharmaceutical Scientist (Research) (Telework eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist (Research). As a Research Scientist, the incumbent serves on multi-disciplinary scientific teams and provides technical guidance in research activities which generally include the characterization of drug products, its formulation and manufacturing process as it relates to drug delivery, in vitro drug release and in vivo drug performance.
Data Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Data Scientist. As Data Scientist, the incumbent will utilize tools and techniques and other appropriate analytical methodologies from disciplines, such as data science, operations research, management science, mathematics, statistics, economics, computer science, and decision science. The primary purpose in this role is to conduct and/or participate in the analyses and evaluation of program policy and operations. This work will provide a basis for, and have a direct effect on, decision affecting major center regulatory policies and programs.
Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist). As an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist), the incumbent is responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology/toxicology or clinical drug review divisions located within OND.
Senior Data Scientist
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis II (DCEA2) is recruiting for a Senior Data Scientist. As a Senior Data Scientist, the selected candidate will serve as a subject matter expert and provide administrative and technical oversight on the integration of in-depth data science knowledge into data analytic and visualization tools that will be utilized to support Office and Center leadership in making evidenced-based regulatory decisions concerning digital health devices, encompassing the entire product lifecycle.
Senior Data Engineer
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ) ,Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis II (DCEA2) is recruiting for a Senior Data Engineer. CEA is seeking innovative, forward thinking and driven Data Engineer(s) to develop, pilot, and implement various data analytics tools within CDRH, while collaborating with a team of Data Scientists, Data Engineers and Developers across the Office and Center and interfacing with contractors to accomplish these goals.
Biopharmaceutics Reviewer
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Biopharmaceutics Reviewer. As the Biopharmaceutics Reviewer, the incumbent will be responsible for reviews of in silico, in vitro, ex-vivo and human PK data submitted to INDs, NDAs, ANDAs, sNDAs, and sANDAs to evaluate the mechanism of action (MOA) as proof-of-activity for use of medicinal products in patients, the safety of medicinal products for use in patients and healthy subjects, and the quality profile of medicinal products in patients in order to recommend approvals of applications.
Science Policy Analyst (Telework Eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Science Policy Analyst. As a Science Policy Analyst, the incumbent provides advice and consultation to Office management on program policy matters, including scientific area of expertise.
Interdisciplinary Engineer
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for an Interdisciplinary Engineer. As an Interdisciplinary Engineer, the incumbent serves on multi-disciplinary scientific teams providing technical leadership and guidance in research designed to resolve specific scientific issues to support regulatory assessment, policy development, and decisions.
Computer Scientist (Band D) (Remote)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Computer Scientist. As a Computer Scientist, the incumbent works to meet mission-critical informatics initiatives in support of CDER’s regulatory operations by assisting in the development of software systems that form the basis of the modern computing environment for scientific review of human drugs and therapeutic biologics.
Associate Director for Oncology
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director for Oncology. As the Associate Director of Oncology, the incumbent applies knowledge of administrative and program management principles and skills to carrying out the mission of the Division.
Pharmaceutical Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist. As the Pharmaceutical Scientist, the incumbent is responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate.
Social Scientist (Band A, B and C Levels)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OS) is recruiting for Social Scientists! As a Social Scientist, the incumbent supports the conceptualization, design, and conduct of complex studies into any aspect of the operation and management of programs and/or processes within the Center. This includes the identification of actual or potential problems, trends, and similar factors in Center operations and recommend solutions to senior management for consideration.
Deputy Division Director of DRM
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for a Deputy Division Director of the Division of Risk Management (DRM).
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Consumer Safety Officer. As a Consumer Safety Officer, the incumbent will serve as the regulatory manager/coordinator for an assigned group of office level programs. Activities may include coordination oversight of programs.
Computer Scientist (Band D) (Remote)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Computer Scientist. As a Computer Scientist, the incumbent works to meet mission-critical informatics initiatives in support of CDER’s regulatory operations by assisting in the development of software systems that form the basis of the modern computing environment for scientific review of human drugs and therapeutic biologics.
Associate Director for Oncology
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director for Oncology. As the Associate Director of Oncology, the incumbent applies knowledge of administrative and program management principles and skills to carrying out the mission of the Division.
Project Coordinator
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Project Coordinator. As a Project Coordinator, the incumbent directly supports the development and review of regulation of medical products.
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Consumer Safety Officer. As a Consumer Safety Officer, the incumbent will serve as the regulatory manager/coordinator for an assigned group of office level programs. Activities may include coordination oversight of programs.
Director, Latin America Office
The Office of the Commissioner, Office of Policy, Legislation and International Affairs Office of Global Policy and Strategy, Office of Global Operations, Latin America Office is recruiting for a Director.
Associate Director
The Office of the Commissioner (OC), Office of Policy, Legislation, and International Affairs (OPLIA), Office of Global Policy and Strategy (OGPS), Immediate Office (IO) is recruiting for an Associate Director. As Associate Director (Physician), the incumbent serves as the Senior Advisor to the Associate Commissioner for Global Policy and Strategy on global health matters.
Informatics Program Manager (Band C)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for an Informatics Program Manager. As an Informatics Program Manager, the incumbent will support the planning and execution of major technology programs consisting of multiple projects.
Informatics Program Manager (Band D)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for an Informatics Program Manager. As an Informatics Program Manager, the incumbent will support the planning and execution of major technology programs consisting of multiple projects.
Associate Director for Medication Error and Risk Management Initiatives
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for Associate Director for Medication Error and Risk Management Initiatives. As the Associate Director (AD) for Medication Error and Risk Management Initiatives in OMEPRM, the incumbent works closely with the Office Director to ensure the advancement of OMEPRM’s programmatic initiatives.
Technical Information Specialist
The Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach, and Development (OCOD), Division of Communication and Consumer Affairs (DCCA), Communication Technology Branch (CTB) is recruiting for a Technical Information Specialist. The incumbent serves the Communication Technology Branch (CTB), Division of Communication and Consumer Affairs (DCCA) in the Office of Communication, Outreach, and Development (OCOD). The DCCA directs and implements Center consumer and professional informational activities. The Division identifies, plans, and develops informational and outreach programs as well as creates content development, design, policy, and management of Center's Internet and Intranet web sites.
Management Analyst
The Center for Biologics Evaluation and Research (CBER), Office of Management (OM) is recruiting for a Management Analyst. The incumbent serves the Office of Management (OM). The Office of Management leads procedural and process changes through developing and applying new strategies to emerging problems and new management initiatives, allocating dollars and staff resources to CBER’s program offices, monitoring their usage, and setting priorities to improve the level of customer service and program performance to meet CBER’s goal of protecting and promoting the public health.
Associate Director for Nomenclature and Labeling DMEPAI
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director for Nomenclature and Labeling DMEPAI. As the Associate Director for Nomenclature & Labeling, the incumbent serves as a senior advisor to the Division Director and Deputy Director on complex scientific, administrative, procedural, and policy issues that are related to the nomenclature, labeling, and packaging of medical products that are important to advancing the programmatic goals.
Associate Director, Animal Bioengineering and Cellular Therapies
The Center for Veterinary Medicine (CVM), Office of the Center Director is recruiting for an Associate Director, Animal Bioengineering and Cellular Therapies . The incumbent will lead CVM’s efforts in continuing to implement its regulatory approach to animal biotechnology and cellular therapy products.
Regulatory Review Resolution Specialist (Center Ombudsman)
The Center for Biologics Evaluation and Research (CBER), Office of the Center Director (OD) is recruiting for a Regulatory Review Resolution Specialist (Center Ombudsman). The incumbent serves as the Regulatory Review Resolution Specialist (Center Ombudsman) in the Immediate Office of the Center Director (IOD) and reports directly to the Center Director, CBER. The incumbent serves as the Ombudsman who acts as an independent mediator in disputes related to the regulated industry and CBER to resolve issues in a manner that is timely, fair, and impartial.
Physician
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Physician. As a Physician on the LPT, the incumbent helps oversee the implementation of prescription drug labeling regulations, FDA labeling guidance, and CDER labeling policies across several clinical prescription drug review divisions.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) is recruiting for a Regulatory Counsel. As a Regulatory Counsel in the Divisions of Regulatory Policy (DRP) I-IV in the Office of Regulatory Policy (ORP), the incumbent is responsible for writing regulations, preparing responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration; drafting and commenting on legislation; and providing advice on the interpretations of the laws, regulations, and policies applicable to the FDA.
Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH) is recruiting for a Division Director. This position reports to the Director of OCE. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other products regulated by OTP.
Deputy Director
The Office of the Comissioner, Office of Minority Health and Health Equity (OMHHE) is recruiting for a Deputy Director. The incumbent serves as Deputy Director of OMHHE, representing senior management in scientific and regulatory matters and provides direction, coordination, and leadership in areas related to minority health and health equity.
Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation General Medicine (DCEGM) is recruiting for a Division Director. The incumbent serves as Division Director, DCEGM, and ensures the safety and effectiveness of biological therapies or devices regulated by OTP used in the prevention, treatment, and mitigation of disease.
Physician - Urologist (OHT3)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 3 (OHT3), Division of Reproductive, Gynecology, and Urology Devices (DHT3B) is recruiting for a Physician - Urologist. As a Physician (Urologist) in OHT3/DHT3B, you will be working on projects involving the full range of medical devices and their accessories used in urological procedures (e.g., peripheral and sacral neurostimulators, surgical mesh for stress urinary incontinence, devices for treatment of voiding dysfunction, prostate cancer treatment devices, etc.).
Consumer Safety Officer (Investigator)
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO) is recruiting for multiple Consumer Safety Officers (Investigator). The Consumer Safety Officer (CSO) has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OBIMO program such as: clinical investigators, nonclinical laboratory facilities, sponsors, contract research organizations, institutional review boards, post marketing adverse drug experience reporting, and risk evaluation and mitigation strategies.