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 positions listed below are being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. 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
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.
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 the manufacturing process and controls, microbiology controls and sterility assurance, and the implementation of the manufacturing control strategy at facilities submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate.
Consumer Safety Officer (Special Assistant)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer. As a Consumer Safety Officer (Special Assistant) in the Office of Compounding and Quality Compliance (OCQC) and the Immediate Office, the incumbent will be responsible for developing and implementing compliance strategies, programs, policies, and communications for protecting the public health that minimize exposure to unsafe, ineffective, and poor-quality compounded drug products while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them.
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.
Data Scientist (Band A/B/C)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Data Scientist. As a Data Scientist 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 (Telework Eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for an Interdisciplinary Scientist. As the Interdisciplinary Scientist, the incumbent provides advice and consultation to office management on pharmaceutical quality standards related policy matters including scientific area of expertise, and provides analysis and recommendations for effective development of OPQ policy and program strategies.
Senior Policy Advisor (Telework Eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Senior Policy Advisor. As the Senior Policy Advisor, the incumbent serves as an advisor to the Associate Director for Policy, as well as an expert on pharmaceutical quality policy, including quality-related legislative issues, conducts assessments of proposed quality-related legislation, and provides authoritative advice to senior OPQ staff, as appropriate, on legislative activities that may impact CDER and the operations of OPQ related to pharmaceutical quality oversight.
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.).
Regulatory Counsel
The Office of the Commissioner (OC), Office of the Chief Scientist (OCS), Office of Counterterrorism and Emerging Threats (OCET) is recruiting for a Regulatory Counsel. The incumbent is a subject matter expert, responsible for providing regulatory, legal and policy matter expertise to advise and support program function within OCET and OCS.
Physician
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Physician. The Physician will serve as a clinical reviewer, with a specialty in Hematology, who is a reviewer and advisor to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products.
Team Lead Physican
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Team Lead Physician. The incumbent will serve as a Lead Physician, with a specialty in Hematology, who serves as a secondary reviewer and is one of the principal advisors to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products.
Social Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Social Scientist. 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.
Data Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Data Scientist. As a Data Scientist the incumbent will serve as a consultative service to the Center that help inform decisions impacting Center regulatory policies and programs.
Communications Specialist (OCD)
The Center for Devices and Radiological Health (CDRH), Office of the Center Director (OCD) is recruiting for a Communications Specialist. Reporting directly to the OCD Associate Director for Strategic Communications, you will serve as advisor to the Associate Director, senior leadership, and Center executives. You will monitor and track medical inquires to the Center, develop and implement center-wide communication procedures for content consistency, and develop, manage, and execute comprehensive strategic communication plans that promote and advance the Center’s values, vision, and mission.
Clinical Analyst
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Clinical Analyst to serve as a contributor on a multi-disciplinary scientific team to arrive at a conclusive clinical opinion on drug applications.
Physician - Neurologist (OHT5)
The Center for Devices and Radiological Health (CDRH), Office of Health Technology 5 (OHT5): Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality (OPEQ) is recruiting for a Physician - Neurologist. This position offers the opportunity to broadly impact and improve the quality of life of patients across many dimensions of health care.
Regulatory Counsel (Telework-eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Regulatory Counsel. As Regulatory Counsel, the incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned area are consistent with statutory requirements and existing policy; that their need is justified, and that scientific and regulatory decisions have been appropriately documented.
Lead General Health Scientist
The Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology (OSE) is recruiting for a Lead General Health Scientist. The Lead General Health Scientist is responsible for serving as advisor planning, coordinating, and evaluating drug safety programs and activities to explore and/or confirm signals and to assess risk.
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.