80 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "Newcastle University" positions at Center for Drug Evaluation and Research (CDER) in United States

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

language model-powered AI tool for use in extracting and summarizing information from application files and labeling and develop new generative and agentic AI models for testing in the evaluation of topical

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

knowledge base is dispersed and “hidden” in different parts of the Agency. Learning Objectives: Under the guidance of the mentor, the participant will train on pharmaceutical science, laws and regulations

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

methods for the generic drug research program and conducts regulatory science and research activities based on quantitative approaches. Some of the responsibilities residing in DQMM include providing

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

impurities and contaminants based on high-risk excipient lists from multiple sources.  This research will include developing a curated high-risk excipient list based on standard definitions of risk (e.g., ICH

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

to their novelty and rapid evolution. The research aims to facilitate product development, assist review decision-making, identify regulatory knowledge gaps, and support evidence-based evaluation approaches

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 | 2 days ago

(PROs) represent the only quantitative tool available to assess tolerability of oncologic agents under development, providing unique insights into the patient experience of symptomatic adverse events

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

unstructured submission data for model development; 2) Apply AI methods to identify key clinical and biomarker features that drive response to therapy; 3) Contribute to manuscripts, reports, and presentations

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

generic drugs. These efforts cover more than just medicines. Research Project: Some biomarkers have been used as multiple roles through one drug development such as a diagnosis biomarker for patient

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

reviewers' conclusions in queryable databases; however, reviewer conclusions are only successfully recorded for a subset of the toxicology study data submitted. These databases will be utilized to train

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug