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
Deputy Office Director
The Office of Regulatory Affairs (ORA), Office of Criminal Investigations (OCI) is recruiting for a Deputy Office Director. Deputy Office Director, OCI (DDCI), serves as the principal advisor to the Assistant Commissioner for Criminal Investigations (ACCI) and other key officials on regulations and criminal matters that affect the Agency and provides executive leadership and technical direction in initiating and conducting criminal investigations under all statutes administered by the FDA through Offices located throughout the United States.
Deputy Division Director (Supervisory Mathematical Statistician)
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for a Deputy Division Director (Supervisory Mathematical Statistician). As a Deputy Division Director (Supervisory Mathematical Statistician), the incumbent is responsible for providing professional leadership and direction to subordinate supervisors and division staff.
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.
Research Scientist (Telework Eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Research Scientist. As a Research Scientist, the incumbent serves 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 Digital & Web Content Manager
The Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM) is recruiting for a Lead Digital & Web Content Manager. As Lead Digital & Web Content Manager, the incumbent servers on Center and Agency Internet and Intranet committees to provide input, and to help coordinate policy, information, content development, training, web site promotion and other web or multimedia activities.
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.
Public Health Analyst
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Public Health Scientist. As a Public Health Analyst, the incumbent provides public health analytical support to OCQC.
Pharmaceutical Scientist (Telework eligible)
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.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Regulatory Counsel. As a Regulatory Counsel in the Office of Unapproved Drugs and Labeling Compliance (OUDLC), the incumbent serves as a Subject Matter Expert (SME) with responsibilities for protecting the public health of U.S. consumers from unapproved and misbranded drug products through the enforcement of compliance laws and regulations.
Associate Director for Manufacturing Quality
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) is recruiting for a Associate Director for Manufacturing Quality. As Associate Director, the incumbent serves 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. The Associate Director assists in developing and evaluating potential impacts of recommended policies.
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.
Senior Data Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Senior Data Scientist. As the Senior Data Scientist, the incumbent will work with the Director and Deputy Director to expand existing business/data analytics capacity and services to support analytics needs across CDER.
Senior Regulatory Health Project Manager (Rare Diseases)
The Center for Biologics Evaluation and Research (CBER), Office of the Center Director (OD), Policy Staff (PS), Regulatory and Policy Staff (RPS) is recruiting for a Senior Regulatory Health Project Manager to provide senior level regulatory policy and project management expertise concerning biological products regulated by the CBER and intended for use in rare diseases
Office of Compliance and Biologics Quality (OCBQ) Deputy Office Director
The Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), Immediate Office is recruiting for a Deputy Office Director to help manage the development of policies and procedures on all regulatory interpretations and analyses.
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.
Branch Chief - Planning, Performance and Formulation Branch
The Center for Biologics Evaluation and Research (CBER) Office of Management (OM) Division of Management Planning and Analysis (DMPA) Planning, Performance and Formulation Branch (PPFB) is recruiting for a Branch Chief to manage the daily operations of the Branch. This position reports to the Director of DMPA.
Deputy Director
Office of Regulatory Management Operations The Office of Regulatory Affairs (ORA), Office of Regulatory Management Operations (ORMO) is recruiting for a Deputy Director. The incumbent serves as the Deputy Director, Office of Regulatory Management Operations (DD-ORMO). The DD-ORMO, along with the Assistant Commissioner for Regulatory Management Operations (ACRMO), has ORA-wide authority for strengthening the management of business programs and regulatory operations.
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.
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.
Pharmaceutical Scientist (Research) (Telework eligible)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR) is recruiting for a Pharmaceutical Scientist (Research) (Telework eligible). 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.
Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for 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.
Associate Director for Public Health Initiatives
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director for Public Health Initiatives. As the Associate Director for Public Health Initiatives, the incumbent assists the Super Office Director in executing the above responsibilities by serving as the Office’s lead scientific expert on Office activities related to complex, multidisciplinary drug safety matters with a broad public health impact.
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). 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.
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). 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. The physician evaluates clinical trial designs for a variety of hematologic indications.
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.
Division Director (Supervisory Regulatory Counsel)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Division Director (Supervisory Regulatory Counsel). As the Division Director, the incumbent serves as principal advisor to the OGDP Office Director and Deputy Office Director on decision-making processes and documents and participates fully in discussions and decisions concerning DLRS and OGDP plans, programs, and activities in both strategic planning and in the actual determination, allocation, and administration of CDER program segments, functions, and activities.
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.
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.
Deputy Division Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Deputy Division Director. As the Deputy Division Director, the incumbent serves as the alter ego to the Division Director in the oversight, leadership, and management of the division.
Laboratory Director, Forensic Chemistry Center (FCC)
The Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Office of Medical Products and Specialty Laboratory Operations (OMPSLO), Forensic Chemistry Center (FCC) is recruiting for a Laboratory Director. The Director is responsible for providing leadership, guidance, and technical direction necessary for full and effective program accomplishments and the effective utilization of available resources.