69 computer-security-"https:"-"https:"-"https:"-"https:"-"https:"-"LGEF" positions at Center for Drug Evaluation and Research (CDER)

FDA Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 days ago

oncology and inflammatory & immune diseases, and to support risk and safety evaluation, to identify endpoints for Type 1 Diabetes. During the appointment, you will use the clinical trial data under NDA and

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

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 3 days 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 Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 3 days ago

for causality assessments of individual case safety reports. The research project is supported under 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 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 | 3 days 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 Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days 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 High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 3 days 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 Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days 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 Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 days 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

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 days ago

the Pediatric Research Equity Act, exceedingly few drug development programs include neonates. As a result, a relatively small number of drugs have the safety and efficacy data necessary to support