76 engineering-computation "https:" "https:" "https:" "https:" "https:" "https:" "University of St" positions at Center for Drug Evaluation and Research (CDER)

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

of funds. Level of Participation: The appointment is full time. Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only. This program, administered

FDA Postdoctoral Fellowship / Research Fellowship: 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 | 40 minutes 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 Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

. Learning Objectives: Under the guidance of a mentor, the participant will learn about the development of computational models for regulatory use. Research and training activities may include: Learning

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 Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 29 minutes ago

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 30 minutes 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 | 31 minutes 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 | 1 day 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 | 1 day 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 Postdoctoral Fellowship in New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

outcomes and optimizing model performance. The participant will help prepare reports, presentations, and publications advancing the regulatory application of MPS technology and may join in developing