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
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.
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 be 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.
Staff Director, Lean Management Staff (LMS)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Lean Management Staff (LMS) is recruiting for a Staff Director to develops, plans, and coordinates the work of LMS and provides authoritative guidance to staff on the application of methods, techniques, and procedures for the conduct of studies, process improvement initiatives, and organizational change management efforts to support improvement to regulatory review processes for medical products.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Bioequivalence (OB) is recruiting for a Deputy Office Director to serve as the primary advisor to the Office Director and provide assistance to the Office Director in the management and direction of the development and implementation of the Agency’s bioequivalence and bioavailability reviews associated with the generic drug program.
Pharmaceutical Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist to be 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),
Scientific Redactor
The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP), Division of Information Disclosure Policy (DIDP) is recruiting for Scientific Redactor to apply redaction skills and good judgment in appropriately redacting scientifically rich information and documents by identifying and removing confidential information before public disclosure.
Mathematical Statistician
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Biostatistics (OB) is recruiting for a Mathematical Statistician to evaluate and advise on protocols for clinical studies and assess the evidence for safety and efficacy from clinical studies submitted in drug and biologics applications.
Physician (Endocrinologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN), Division of General Endocrinology (DGE) is recruiting for a Physician (Endocrinologist) 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, including decisions related to changes to already marketed products.
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).
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.