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
Associate Director for Professional Development
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ) is recruiting for an Associate Director for Professional Development to be responsible for overseeing programs that foster the professional development of the multidisciplinary workforce within the Office.
Associate Director for Manufacturing Quality
The Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) is recruiting for an Associate Director for Manufacturing Quality to serve as a senior advisor to the Office Director and Deputy Office Director, OCBQ, concerning the manufacturing of CBER-regulated biological products, including advising on issues involving compliance with current good manufacturing practice requirements, other regulatory compliance issues, enforcement, and policy issues related to manufacturing, in close consultation with the Associate Director for Policy, OCBQ.
Deputy Division Director
The Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP), Office of Medical Policy Initiatives (OMPI), Division of Medical Policy Programs (DMPP) is recruiting for a Deputy Division Director to be directly responsible for the implementation of complex and precedent setting medical policy programs and initiatives across a broad range of medical/clinical and technological subject matter, including drug development and drug approval processes, consumer-directed medical information, professional labeling, and other subject matter areas as assigned by the Division Director.
Research Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR) is recruiting for a Research Scientist to serve on multi-disciplinary scientific teams and provides technical guidance in research activities designed to resolve specific scientific issues to support regulatory assessment, policy development, and decisions.
Lead Artificial Intelligence/Machine Learning
The Office of the Commissioner, Office of Digital Transformation, Office of Data, Analytics and Research is recruiting for a Lead Artificial Intelligence/Machine Learning to serve as an advisor to the Chief Data Officer and senior management officials across FDA.
Deputy Super Office Director for Operations
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Immediate Office (IO) is recruiting for a Deputy Super Office Director for Operations to be responsible for providing oversight for the support of all OGD operational elements including formulating and establishing Office goals in assessment and approval of human generic drug products and executing those goals by providing the regulatory and operational strategy, establishing the efficient processes, and allocating resources.
Public Affairs Specialist (Press Officer) (Band B & C)
The Office of the Commissioner (OC), Office of External Affairs (OEA), Office of Media Affairs (OMA) is recruiting for a Public Affairs Specialist (Press Officer) to be responsible for the coordination of media relations activities for assigned “beat” areas.
Public Affairs Specialist (Press Officer) (Band D)
The Office of the Commissioner (OC), Office of External Affairs (OEA), Office of Media Affairs (OMA) is recruiting for a Public Affairs Specialist (Press Officer) to be responsible for the coordination of media relations activities for assigned “beat” areas.
Project Coordinator
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) is recruiting for a Project Coordinator to support 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), Office of Regulatory Operations (ORO) is recruiting for a Consumer Safety Officer to serve as the regulatory manager/coordinator for an assigned group of drug/biologic products or office level programs.
Interdisciplinary Scientist (IDS)
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Translational and Precision Medicine (DTPM) is recruiting for an Interdisciplinary Scientist (IDS) to serve as the scientific expertise as a member of multi-disciplinary scientific and medical teams engaged in review, evaluation, and decision-making regarding approvability of submissions and applications requesting FDA regulatory consideration of clinical research.
Deputy Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Management (OM), Division of Management Planning and Analysis (DMPA) is recruiting for a Deputy Division Director to serves as the Deputy Division Director of the Division of Management Planning and Analysis (DMPA) under the Office of Management (OM) and manages daily operations of the Division.
Physician (Hematology)
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 (Hematology) to 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.
Lead Physician (Hematology)
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 Lead Physician (Hematology) to 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.
Branch Chief
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 Branch Chief to guide the clinical review program which include evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders.
Supervisory Senior Scientist
The Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE) is recruiting for a Supervisory Senior Scientist to serve as an authoritative expert and resource to facilitate the application of quality regulatory science and science policy for the review and regulation of new and generic animal drugs.
Interdisciplinary Scientist (IDS)
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Study Integrity and Surveillance (OSIS) is recruiting for an Interdisciplinary Scientist (IDS) to serve and be responsible for evaluating scientific data and analytical and bioanalytical methods contained in the new or generic drug submissions to the Agency.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdisciplinary Scientist to be 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.
Scientific Data Analyst
The Center for Biologics Evaluation and Research (CBER), Office of the Center Director (OD), Science Staff (SS) is recruiting for a Scientific Data Analyst to work as part of a team in managing multiple computer–based systems (i.e., Research Central and REES Environmental Monitoring System) that are used for monitoring and tracking regulatory science and research activities, such as research programs, publications, and related research program support budgets.