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
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 develop, maintain, and manage the administration the Rare Diseases Team’s (RDT) 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 develop, maintain, and manage the administration the Rare Diseases Team’s (RDT) multiple obligations to facilitate internal agency coordination and external engagement for our multiple external stakeholders (e.g. industry, foundations, and patient advocacy groups).
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Compounding Quality and Compliance (OCQC), Division of Compounding Policy and Outreach (DCPO) is recruiting for a Consumer Safety Officer to provide Subject-Matter-Expertise (SME) to advise and support outreach and program activities within the Compounding Branch 6, Division of Compounding Policy and Outreach (DCPO), Office of Compounding Quality and Compliance (OCQC), Office of Compliance.
Lead Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Compounding Quality and Compliance (OCQC), Division of Compounding Policy and Outreach (DCPO) is recruiting for a Lead Regulatory Counsel to develop and implement compliance strategies, programs, policies, and communications for protecting the public health that minimize exposure to unsafe, ineffective, and poor-quality compounded drug products.
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Compounding Quality and Compliance (OCQC), Division of Compounding I and II is recruiting for a Consumer Safety Officer to 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.
Quality Assurance Specialist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Program and Regulatory Operations (OPRO) is recruiting for a Quality Assurance Specialist to serve as a specialist who implements the Quality Management Plan (QMP) or other established guidelines for the CDER Quality Management System for the chemistry, manufacturing, and controls (CMC) review processes.
Director
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO) Office of Medical Devices and Radiological Health Operations (OMDRHO) is recruiting for a Director to serve as the primary advisor to the Assistant Commissioner for Medical Products and Tobacco Operations (ACMPTO). The incumbent is responsible for establishing scientific policy and policy guidance; provide scientific and technical direction and develop short/long term goals for the OMPTO.
Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) is recruiting for a Division Director to review, evaluate and recommend appropriate action on investigational new drug applications (INDs), Biologics License Applications (BLAs), new drug applications (NDAs), and 510 (k) and premarket applications (PMAs).
Consumer Safety Officer (Special Assistant)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Compounding Quality and Compliance (OCQC) is recruiting for a Consumer Safety Officer (Special Assistant) to 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.
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Response (ODSIR) is recruiting for a Consumer Safety Officer to provide technical support within the ODSIR Immediate Office (IO) for the operation and integration of Drug Supply Chain Security Act (DSCSA) program requirements by 2023.
Physician
The Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is recruiting for a Physician to serve as a scientific and regulatory subject-matter expert for real-world evidence (RWE) analytics in the Immediate Office of the Office of Medical Policy (OMP).
Lead Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Response (ODSIR) is recruiting for a Lead Consumer Safety Officer to serve as a recognized authority in scientific matters related to drug security, integrity, and response.
Public Health Analyst (Special Assistant)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Response (ODSIR) is recruiting for a Public Health Analyst (Special Assistant) to serve as a Special Assistant to the ODSIR Director and addresses overreaching issues that impact the development of policies and compliance strategies protecting the public health.
Physician (Cardiologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN), Division of Cardiology and Nephrology (DCN) is recruiting for a Physician (Cardiologist) to be responsible for providing regulatory oversight for investigation studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs.
Physician
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office for Therapeutic Biologics and Biosimilars (OTBB), Scientific Review Staff (SRS) is recruiting for a Physician to provide oversight and scientific review of biosimilars throughout the product lifecycle.
Clinical Analyst
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office for Therapeutic Biologics and Biosimilars (OTBB), Scientific Review Staff (SRS) is recruiting for a Clinical Analyst to evaluate submissions from applicants seeking permission to market biosimilar biological products, provide advice to sponsors on matters pertaining to biosimilar biological product development, and make recommendations on the adequacy of the data and information provided.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drugs and Labeling Compliance (OUDLC), Division of Unapproved Drugs and Labeling (DUDL), Prescription Drugs Branch (PDB) is recruiting for a Regulatory Counsel to 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.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdisciplinary Scientist to review and evaluate drug applications and communicates conclusions with a multidisciplinary review team.