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
Assistant Director - Division of Regulatory Programs I
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Regulatory Programs (ORP) is recruiting for an Assistant Director in the Division of Regulatory Programs I to plan, lead and coordinate the end-to-end medical device review support activities in the areas of policy evaluation and interpretation and medical device classification in the pre-market space as well as compliance and enforcement efforts in the post-market space.
Associate Director for Counter-Terrorism and Emergency Preparedness (CTEP)
The Center for Drug Evaluation and Research (CDER), Office of the Center Director, Immediate Office is recruiting for an Associate Director for Counter-Terrorism and Emergency Preparedness to provide oversight, direction, and supervision to the Counter-Terrorism and Emergency Coordination Staff (CTECS) which includes a staff of scientists, physicians, and program managers.
Lead Pharmacologist
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Division of Enforcement and Postmarketing Safety (DEPS), Office of Scientific Investigations (OSI), Postmarket Safety Branch (PSB) is recruiting for a Lead Pharmacologist to serve as a source of informed opinion and information on medical and scientific matters related to CDER’s adherence to regulations and statues governing postmarket adverse drug experience reporting requirements.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP), Division of Legal and Regulatory Support (DLRS) is recruiting for a Regulatory Counsel to develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products.
Deputy Division Director
The Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) is recruiting a Deputy Division Director to be responsible for providing leadership, administrative management, and exercising sound scientific and evidenced-based technical judgement in the review of in-scope medical products throughout their total product lifecycle.
Supervisory Regulatory Counsel
The Center for Veterinary Medicine (CVM), Office of Surveillance and Compliance (OS&C) is recruiting for a Supervisory Regulatory Counsel to serve as an expert advisor to Office, Center, and Agency staff regarding the laws and regulations relating to pre-market surveillance and compliance activities of regulated animal products.
Regulatory Counsel
The Center for Veterinary Medicine (CVM), Office of the Director (OD) is recruiting for a Regulatory Counsel to conduct legal analyses of CVM and Agency records to determine whether documents can be released in litigation or in response to third-party subpoenas.
Science Policy Analyst (Band C)
The Center for Drug Evaluation & Research (CDER), Office of New Drugs (OND), Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine (ORPURM), Division of Rare Diseases and Medical Genetics (DRDMG) is recruiting for a Science Policy Analyst to provide expertise to develop, maintain, and manage the administration the Rare Diseases Team’s multiple obligations to facilitate internal agency coordination and external engagement for our multiple external stakeholders (e.g., industry, foundations, and patient advocacy groups).
Science Policy Analyst (Band D)
The Center for Drug Evaluation & Research (CDER), Office of New Drugs (OND), Office of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine (ORPURM), Division of Rare Diseases and Medical Genetics (DRDMG) is recruiting for a Science Policy Analyst to provide support to the Supervisory Associate Director on matters that have a direct effect on the review and evaluation of rare disease drug development actions, policies, and programs.
Science Policy Analyst (Band A, B, C)
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Patient Focused Drug Development (PFDD) is recruiting for a Science Policy Analyst to Provides assistance related to the planning, development, administration, execution, and coordination of programs, initiatives, and policies in Patient Focused Drug Development.
Science Policy Analyst (Band D)
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Patient Focused Drug Development (PFDD) is recruiting for a Science Policy Analyst to provide advice on matters that have a direct effect on patient focused actions, policies, and programs.
Branch Chief (Supervisory Physician)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI) is recruiting for a Branch Chief (Supervisory Physician) to serve as a technical and scientific authority in the area of Good Clinical Practice (GCP), including data integrity and clinical trial conduct, evaluating the reliability of clinical data relating to the safety and effectiveness of a broad range of drugs pending approval before CDER.
Director, Office of Vaccines Review and Research (OVRR)
The Center for Biologics Evaluation and Research (CBER), Office of Vaccines Review and Research (OVRR) are is recruiting for a Director to review and evaluate the safety and efficacy of investigational new drug applications (INDs) and IND amendments for vaccines and related biological products, provide guidance and recommendations to IND sponsors with regard to the chemistry, manufacturing and control information, preclinical safety assessments and first-in-man clinical trials for these products.