32 engineering-computation "https:" "https:" "https:" "https:" "https:" "https:" "University of St" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

leveraging Artificial Intelligence (AI) usage in open-source. This project aims to develop innovative assessment capabilities using techniques such as prompt engineering, data extraction, NLP, time series

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 5 hours ago

Objectives: During the appointment, you will learn how to: Design bispecific and trispecific antibodies/fusion proteins using genetic engineering approaches while applying appropriate structural and functional

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 4 hours ago

diversity across patient populations, including pediatrics, largely due to the revolutionary acceleration of DNA sequencing technology, driven by the development of Next-Generation Sequencing (NGS) and its

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 4 hours ago

be integrating current knowledge of microbiology, labeling, packaging technology, and consumer behavior to gain insights into potential microbial contamination risks.  This project strengthens FDA’s

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 | about 4 hours ago

and streamline clinical development program, contributing to precision medicine. Learning Objectives: The project provides training opportunities to understand quantitative approaches that can be

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 4 hours ago

. citizens, 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

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

to deliver faster and more accurate results along with establishment of a detection tool. Learning Objectives: Under the guidance of the mentor(s), you will be able to explore CDER post market report program

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 4 hours ago

decision-making. This educational and developmental program provides you with training opportunities to continue your education and research while enhancing your professional skills. You will also become

FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 4 hours ago

: This opportunity is available to U.S. citizens, 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