29 Education research jobs at Center for Drug Evaluation and Research (CDER)

FDA Bioequivalence of Complex Generic Products Fellowship

to understand the formulations that have been approved under abbreviated new drug applications (ANDAs) and NDAs. The project will also identify and develop in vitro, in vivo, or in silico techniques that may be

FDA Fellowship in Program, Policy and Operational Analysis

quantitative data, and synthesize and present findings. This project is critical to our public health mission and the training will prepare the participant for a successful career transition into regulatory

FDA-CDER Fellowship in the Intranasal Administration of Monoclonal Antibodies and other Biological Therapeutics

that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established

FDA Oligonucleotide Research Fellowship

entail executing experimental designs, conducting laboratory analyses to develop analytical methods comprehensively, and gaining insight into drug development and product quality control. Additionally

FDA Postdoctoral Glyco-technology Lab Fellowship

the guidance of the mentor, the participant will learn state-of-the-art technologies and develop novel technologies for feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal

FDA Modeling and Simulation Fellowships

and other generic products with clinical study challenges. Develop/apply PBPK absorption models for oral drug products to support biowaiver and risk-based BE assessment. Innovative approaches

FDA In Vitro and In Vivo Bioequivalence Fellowship

develop proposals for novel in vitro, in vivo, or in silico techniques that may be capable of determining whether various complexity factors related to generic drug products will impact their bioequivalence

FDA Predictive Analytics Fellowship

the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly

FDA Product Specific Guidance and Research Fellowship

manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational

FDA Pharmacovigilance Fellowship: Characterization of Newly Identified Safety Signals

through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant