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
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.
Physician
The Center for Biologics Evaluation and Research (CBER), Office of Vaccines Review and Research (OVRR), Division of Vaccines and Related Product Applications (DVRPA) is recruiting for a Physician. The Physician conducts clinical reviews and requires a scientific medical knowledge of the infectious diseases and allergy and immunology diseases being treated.
Branch Chief
The Center for Biologics Evaluation and Research (CBER), Office of Regulatory Operations (ORO), Division of Information Technology (DIT), Program Management and Analysis Branch (PMAB) is recruiting for a Branch Chief. This position reports to the Director of DIT. As the Branch Chief, the incumbent oversees the activities and functions related to the Branch.
Consumer Safety Officer (OC/OCQC)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer (OC/OCQC). As a Consumer Safety Officer, the incumbent is responsible for supporting a program function on a Team that resides within a Branch in one of two Divisions of Compounding in the Office of Compounding Quality and Compliance.
Deputy Division Director (OCE/DC)
The Center for Devices and Radiological Health (CDRH), Office of Communication and Education (OCE), Division of Communication (DC) is recruiting for Deputy Division Director. The incumbent will manage the development and implementation of strategic plans, messaging, and related communication materials, simplifying complex technical, legislative, regulatory, legal or other general issues.
Staff Director
Biological Products Operations II The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Biological Products Operations (OBPO), Division of Biological Products Operations II (DBPOII) is recruiting for a Staff Director.
Branch Chief, SREB
The Center for Drug Evaluation and Research (CDER), Office of Executive Programs (OEP) is recruiting for a Branch Chief for the Scientific and Regulatory Education Branch (SREB). As the Branch Chief of the SREB, the incumbent directs the development and formulation of Center-wide learning philosophy and policy, providing significant influence to the conduct of CDER learning and development programs, ensuring a comprehensive approach to staff development and learning. Participates with the Division Director in formulating the overall CDER training budget, developing competencies, and formulating Center's training policies and philosophy.
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.
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.
Laboratory Director, 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.
Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Regulatory Operations (ORO), Division of Information Technology (DIT) is recruiting for a Division Director. This position reports to the Director of ORO. As the Division Director, the incumbent oversees the daily development and management of the CBER Information Technology (IT) Investments in review, scientific, and administrative areas.
Physician (Surgeon)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Physician (Surgeon). As a Physician (Surgeon), the incumbent will be responsible for providing regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs.
Interdisciplinary Scientist (Pharmacokineticist)
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for an Interdisciplinary Scientist (Pharmacokineticist). As a Pharmacokineticist, the incumbent will serve in the Division of Cancer Pharmacology I or Division of Cancer Pharmacology II in the Office of Clinical Pharmacology.
Computer Scientist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for a Computer Scientist. As a Computer Scientist, the incumbent provides mission-critical informatics initiatives in support of OTS’s regulatory operations by assisting in the development of software systems that form the basis of the modern computing environment for management activities which support the scientific review of human drugs and therapeutic biologics.
Data Scientist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for a Data Scientist. As a Data Scientist, the incumbent supports the conceptualization, designs, and conduct of leveraging data into knowledge management efforts and regulatory science within the Center.
Division Director
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Division Director. As Division Director, the incumbent partners with the Office Director and Deputy Office Director in providing scientific leadership and management of review, regulation, and research assuring the safety, efficacy, and quality of biological products and biosimilar biological products as specified by the Public Health Service (PHS) Act and applicable provisions of the Federal Food, Drug & Cosmetic (FD&C) Act through their product lifecycle.
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. The Associate Director for Professional Development (ADPD) position is located within one of the OPEQ offices and is responsible for overseeing programs that foster the professional development of the multidisciplinary workforce within the Office.
Deputy for Therapeutics, Quality, and Emerging Regulatory Operations
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO) is recruiting for a Deputy for Therapeutics, Quality, and Emerging Regulatory Operations. The Deputy for Therapeutics, Quality, and Emerging Regulatory Operations (Deputy) shares fully with the ACMPTO and the Deputy for Technology and Bioresearch Quality and Support Operations, in the facilitation of office staff coordination between multiple, smaller program offices.
DETAIL - Deputy for Therapeutics, Quality, and Emerging Regulatory Operations (DTQERO)
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO) is recruiting for a Deputy for Therapeutics, Quality, and Emerging Regulatory Operations (DTQERO). The Deputy for Therapeutics, Quality, and Emerging Regulatory Operations (Deputy) shares fully with the ACMPTO and the Deputy for Technology and Bioresearch Quality and Support Operations, in the facilitation of office staff coordination between multiple, smaller program offices.
Deputy Division Director (Clinical)
The Center for Biologics Evaluation and Research (CBER), Office of Vaccines Review and Research (OVRR), Division of Vaccines and Related Product Applications (DVRPA) is recruitin for a Deputy Division Director. The Deputy Division Director (Clinical) reports directly to the OVRR Office Director. The incumbent collaborates fully with the Office Director and Deputy Office Director to direct a staff of physicians and scientists engaged in the review and evaluation of Investigational New Drug Applications (INDs), Biologics License Applications and Supplements (BLAs and sBLAs) concerned with biological products regulated by the OVRR.
Branch Chief
The Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), Division of Emerging and Transfusion Transmitted Diseases (DETTD), Product Review Branch (PRB) is recruiting for a Branch Chief. The Branch Chief for the Product Review Branch (PRB) reports to the Director, Division of Emerging and Transfusion Transmitted Diseases (DETTD) and is responsible for supervision, technical leadership, and guidance for activities pertinent to regulatory applications in the area of detection of infectious agents in blood and blood products and the diagnosis of retroviral infections.
Branch Chief
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. As the Branch Chief of the Planning, Performance, and Formulation Branch (PPFB) within the Division of Management Planning and Analysis (DMPA), the incumbent will manage the daily operations of the Branch. This position reports to the Director of DMPA.
Associate Director, Epidemiology
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director, Epidemiology.As an Associate Director, the incumbent serves as the principal scientific advisor to the DEPI Directors on all pharmacoepidemiology, drug safety and effectiveness, and regulatory science-related matters.
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.
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.
Deputy Division Director – OCE/DC
The Center for Devices and Radiological Health (CDRH), Office of Communication and Education (OCE) is reruiting for a Deputy Division Director. Located in the Division of Communication, the Deputy Division Director partners with the Division Director in developing and implementing the Center’s external and internal communication strategy.
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 Cheif. The Branch Chief guides 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.
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.
Epidemiologist
The Center for Drug Evaluation and Research (CDER), Divisions of Epidemiology (DEPI I and II) is recruiting for an Epidemiologist who will be responsible for managing pre- and post-approval drug safety and efficacy review, review of epidemiologic submissions from regulated industry, overseeing a portfolio of drug products for which they are responsible for managing post-approval safety and safety signal evaluation.
CVM, Director of the Office of Minor Use and Minor Species (OMUMS)
The Center for Veterinary Medicine (CVM) is looking to fill a critical leadership position - the Director, Office of Minor Use and Minor Species. The Supervisory Veterinary Medical Officer, Office Director ensures the appropriate evaluation of requests for designation of new animal drugs intended for minor use or minor species in accordance with Section 573 of the Federal Food, Drug, and Cosmetic Act (FFDCA) including initial requests, modification, termination, and annual reports.
Division Director
The Center for Devices and Radiological Health (CDRH) is recruiting a Division Director to serve in the Office of Clinical Evidence and Analysis (OCEA or Office). This Office, within the Office of Product Evaluation and Quality (OPEQ), provides policy and programmatic support for clinical trials, the protection of human subjects, biostatistics, real-world evidence, epidemiological analysis and outreach, and collaborates with hospitals, health systems, industry, and other external stakeholders.
Deputy Director, DMEPA I
The Center for Drug Evaluation and Research (CDER), Office of Medication Error Prevention and Risk Management (OMEPRM), Divisions of Medication Error Prevention and Analysis I (DMEPA I) is recruitnig for a Deputy Director. As Deputy Division Director, the incumbent shares responsibility with the Director in planning, managing, organizing, and directing all operations, functions, and activities of the Division as carried out by Associate Directors, team leaders and staff with professional, medical, and scientific skillsets such as, physicians, pharmacists, nurses, engineers, and social scientists, serving in the roles of safety evaluators and human factors (HF) specialists to meet the goals and mission of the organization.
Interdisciplinary Scientist (Pharmacokineticist)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for Interdisciplinary Scientists in the following offices: Office of Bioequivalence, Office of Safety and Clinical Evaluation, and Office of Research and Standards to conduct the scientific evaluation of generic drug products and determine the acceptability of scientific and regulatory applications through the assessment and evaluation of submissions.
Super Office Director (Office of Therapeutic Products)
The Center for Biologics Evaluation and Research, Office of Therapeutic Products (OTP) is recruiting for a Super Office Director to provide executive leadership to six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy.
Super Office Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting a Super Office Director. As the Director of the Office of Generic Drugs (OGD), the incumbent is responsible for directing OGD activities which include developing and implementing standards for the safety, effectiveness, and quality of generic drugs, reviewing, and evaluating Abbreviated New Drug Applications (ANDAs) and their amendments or supplements to determine approvability, establishing bioequivalence specifications for drug products, including overseeing a regulatory science program to inform these activities, and developing guidelines for bioequivalence reviews, industry protocols, and studies.
Senior Clinical Advisor for Mental Health
The Office of the Commissioner is recruiting for a Senior Clinical Advisor for Mental Health to provide advice to the Commissioner and perform substantive work that cuts across major Agency-wide programs and activities.
Senior Clinical Advisor for Chronic Disease
The Office of the Commissioner is recruiting for a Senior Clinical Advisor for Chronic Disease to provide advice to the Commissioner and perform substantive work that cuts across major Agency-wide programs and activities.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Regulatory Counsel. As a Regulatory Counsel, the incumbent develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products. Drafts or critically reviews documents that state or interpret Center or FDA policy for the regulated industry and other effected groups, embodying policy and program proposals and decisions on these products.
General Health Scientist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for General Health Scientist. As a General Health Scientist, the incumbent is responsible for the evaluation of the safety, efficacy, and/or substitutability of generic drugs consumed by the American people. Researches appropriate precedents, databases, and reference material in depth to gather, review, and evaluate existing regulations and guidance and new information about specific drug products or drug classes.
Physician
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Physician. As a Physician, the incumbent serves as a primary reviewer responsible for the scientific evaluation of clinical studies supporting development and approval of generic drugs. Assesses substitutability for proposed generic drug-device combination products, including assessment of comparative analysis.