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
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.
Lead 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 Lead Consumer Safety Officer to be responsible for leading a team within Compounding Branch 5, Division of Compounding Policy and Outreach (DCPO), Office of Compounding Quality and Compliance (OCQC), Office of Compliance.
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.
Lead Pharmacokineticist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) is recruiting for a Lead Pharmacokineticist to serve as a principal advisor to the Division Director, Deputy Division Director, and Associate Directors in a specified therapeutic area, and the lead a team of clinical pharmacology reviewers in this therapeutic area responsible for issues pertaining to clinical pharmacology and biopharmaceutics reviews.
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.