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
Data Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS) is recruiting for a Data Scientist to serves as a specialist in the application of data science, operations research, computer science, mathematics, and statistics, to design data modeling processes, uncover hidden patterns in the data, and create algorithms and predictive models to extract insights that improve the assessment of the state of pharmaceutical quality.
Assistant Director, Infusion Devices
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 3 (OHT3), Division of Health Technology 3C (DHT3C) is recruiting for an Assistant Director, Infusion Devices to provide technical leadership and exercises scientific and engineering judgment in regulating various medical products, primarily drug infusion devices.
Deputy Division Director (Supervisory Data Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis II (DCEA2) is recruiting for a Deputy Division Director (Supervisory Data Scientist) to serve as the authoritative voice on analytical, statistical, and programmatic techniques to collect, organize, analyze, and interpret unique and highly specialized data sets related to the pre-market review, compliance assessment, and post-market surveillance of medical devices and products.
Artificial Intelligence Advisor
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA) is recruiting for a Artificial Intelligence Advisor to be charged with advancing the Office’s strategic vision for the development and implementation of AI and ML initiatives that support OCEA and OPEQ in the TPLC review of medical devices.
Office Director (Supervisory Regulatory Counsel)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP) is recruiting for an Office Director (Supervisory Regulatory Counsel) to serves as the principal administrative, technical, and regulatory authority on all matters related to generic drug regulatory authorities.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdisciplinary Scientist to be responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team.
Data Scientist (Analytics and Data Services Staff)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Analytics and Data Services Staff (ADSS) is recruiting for a Data Scientist to be responsible for conducting and/or participating in the analysis of program policy and operations.
Research Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Research Scientist to serve 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.
Science Policy Advisor
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD), Immediate Office (IO) is recruiting for a Science Policy Advisor to acts as a public-health focused subject matter expert supporting the Associate Director for Controlled Substances on strategic controlled substances programs and policies.
Senior Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Immediate Office (IO) is recruiting for a Senior Consumer Safety Officer to plan, develop, and direct compliance and enforcement strategies that are patient-focused and risk-based to secure the safety, efficacy, and quality of the nation’s drug supply.
Physician (Dermatologist, Immunologist, or Internist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Immunology and Inflammation (OII), Division of Dermatology and Dentistry (DDD) is recruiting for a physician to provide regulatory oversight for investigational 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; monitoring the post market safety and effectiveness of medical drug products marked and used nationwide.
Statistician
The Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB) is recruiting for a Statistician to use scientific knowledge of the theories, principles and concepts of statistics to conduct meaningful analyses and interpretation of clinical safety data.