80 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "University of Plymouth" positions at Center for Drug Evaluation and Research (CDER)

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

miscategorization of subjects with potential DILI risk during regulatory review.  Through this opportunity, you will cooperate in research and training activities related to computer modeling and statistical analyses

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

pediatric drug development of these products. The selected fellow will be involved in the following activities related to the research project: collecting data from public and proprietary sources, analyzing

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

barrier integrity and permeability, and compare in vitro findings with available clinical and pharmacokinetic data to assess model performance. These activities will advance understanding of maternal–infant

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

methods informs OTC drug monographs and labeling. Scientific writing and data analysis/synthesis: Developing a peer-reviewed manuscript for a regulatory science journal with data tables and visual

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 19 days ago

foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

website for information about the valid immigration statuses that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to

FDA Fellowship - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

-on training to retrieve data from relevant FDA databases and tools. Under the guidance of mentors, you will learn about regulations, policies, and procedures pertinent to postmarketing drug safety surveillance

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

, data analysis, and regulatory submission evaluations to identify knowledge gaps and establish best practices for assessment. You will analyze clinical trial datasets to characterize dose-response

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

dose selection based on adult data and patient-specific factors. Specifically, the fellow will: Survey clinical development programs for IBD products, focusing on dose-selection strategies for adults and