80 computer-security "https:" "https:" "https:" "https:" "https:" "Washington University in St" positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Elsa API integration and Development of Advanced User Interface for InfoViP

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 20 hours ago

join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning opportunity. You will receive mentorship by experts in the field, which is a

FDA In Vitro and In Vivo Bioequivalence Fellowship

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

research questions involving challenging active/inactive ingredients, sophisticated formulations, and innovative dosage forms; 3) Advanced human subject safety for bioequivalence trials - Conduct meta

FDA Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 20 hours ago

their molecular complexity. This complexity arises from diverse chemical modifications aimed at enhancing the stability, efficacy, and safety of these products. Consequently, there is a pressing need to enhance

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

focusing on injection, otic, and ophthalmic drug products.  You will gain experience evaluating the safety and manufacturing considerations of generic drug products approved in multiple jurisdictions and

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

 contribute to projects that are mandated under the 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use or risks from sources other than clinical trials

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

products, with no clinically meaningful differences in safety, purity, or potency. Despite advances in analytical and functional characterization, establishing a robust quantitative link between analytical

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

industry submissions. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning opportunity. You will receive

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

advanced computational tools under mentorship guidance, and exploring how statistical innovations can enhance regulatory assessments of drug safety and efficacy. Developing expertise in Bayesian hierarchical

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

detecting safety signals, particularly valuable in early-phase trials with limited sample sizes where critical dose optimization decisions must be made. You will join a project to prospectively assess the use