30 structural-engineering "https:" "https:" "https:" "https:" "https:" "UCL" "UCL" "UCL" "UCL" positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

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

technology, which has been identified as a rapid microbial method that aligns with current pharmaceutical industry trends, to better support submissions utilizing this approach. Researching collaboratively

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 | 3 days ago

analyses in clinical trial submissions to the U.S. Food and Drug Administration (FDA). The project focuses on developing a structured framework to guide statistical reviewers in evaluating mediation analyses

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 | 19 days ago

analyses in clinical trial submissions to the U.S. Food and Drug Administration (FDA). The project focuses on developing a structured framework to guide statistical reviewers in evaluating mediation analyses

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

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 Opportunity - Web-based Visualization Tool for NDA/BLA Submission Info

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

safety data structure, and advanced technical skills in data visualization and web application development. Mentor: The mentors for this opportunity are Dr. Jizu Zhi (jizu.zhi@fda.hhs.gov ), Dr. Megan

FDA Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

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

will: Gain foundation knowledge in antiretroviral drug classes, meta-analysis methodologies, clinical trial data analysis, and R programming. Training in this area will occur through a structured program

FDA Bayesian Inference for Safety Signal Detection

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

Science (CDS) staff, you will develop comprehensive expertise in Bayesian statistical methods for safety signal detection. Training will include structured learning through selected reading, guided coding

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: This research project aims to develop quantitative structure-activity relationship

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

/ML can uncover patterns across regulatory submission data to enhance understanding of drug response variability. Key training activities will include how to: 1) Curate and preprocess structured and

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

the structure and content of internal regulatory science databases Gain familiarity with accepted regulatory science data management and governance procedures Help develop tools to visualize trends and analyses