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 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.
Science Policy Analyst
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Policy for Pharmaceutical Quality (OPPQ) is recruiting for a Science Policy Analyst to provide advice and consultation to Office management on program policy matters, including those in the incumbent’s scientific area of expertise.
Scientific Redactor
The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP), Division of Information Disclosure Policy (DIDP) is recruiting for a 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.
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.
Associate Director for Digital Health Technologies
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office for Drug Evaluation Science (ODES) is recruiting for an Associate Director for Digital Health Technologies to serve as the principal advisor to the ODES Office Director in matters relating to Digital Health Technologies.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS) is recruiting for an Interdisciplinary Scientist to work on a multi-disciplinary team performing reviews of the literature, assist in designing clinical studies, and interpreting and analyzing clinical study data.