67 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "https:" "University of Kent" positions at Center for Drug Evaluation and Research (CDER)

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

molecular attributes and biological responses. This project proposes to develop an AI/ML-integrated translational framework that associates analytical quality parameters to PK, immunogenicity, and safety

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 12 days ago

will contribute to developing internal FDA guidance and supporting peer-reviewed publications on appropriate non-inferiority study design and margin justification in modern ophthalmic drug development

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

drug. Historically, increases in liver enzymes (ALT and AST) has been used to identify subjects with potential DILI during drug development. However, local laboratory normal reference ranges can vary

FDA Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

to public health as a social science analyst in our office or in another FDA office. The skills learned during this opportunity will prepare you for a research-focused career. Public service experience is

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

components for each ORISE fellow (computational, complex in vitro modeling - CiVM and bioanalytical). Computational: The participant will assist in the development of quantitative systems pharmacology models

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

assumptions is well recognized in pediatric drug development. The FDA has access to data from approximately 1,200 pediatric clinical trials of which data from 600 trials spanning over 300 pediatric development

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 23 hours ago

development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—including ten biologics and four small molecules—have been approved

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

drug monographs and labeling. Scientific writing and data synthesis: Developing a peer-reviewed manuscript for a regulatory science journal with data tables and visual infographics. Interdisciplinary

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 23 hours ago

microfluidic devices; 2) Barrier function and transport studies (including permeability assays and imaging-based analyses); 3) Analytical method development using fluorescence microscopy, ELISA, and LC–MS