14 construction-"https:"-"https:"-"https:"-"https:" research jobs at Center for Drug Evaluation and Research (CDER)

FDA NLP Consumer Data Review Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

the structure and content of typical consumer study datasets, including the types of questions asked and the nature of participant responses. Define core NLP concepts relevant to text analysis, such as

FDA Fellowship: Evaluation of Novel Endpoints and Innovative Statistical Methodology in Oncology Clinical Trials

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

, findings, and scientific priorities. Build scientific communication skills by presenting research findings at internal FDA meetings and, when appropriate, external scientific conferences. Gain experience

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

approval, and constructing simulation datasets grounded in real data characteristics to assess surrogacy under scenarios not fully represented in existing data. You will also have the opportunity

FDA Fellowship in Development and Control of Cell Free Manufacturing Platform Technologies

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

communication during presentation construction and the delivery of research findings to a regulatory audience. Learn presentation skills and training in scientific manuscript drafting. Support your scientific

FDA Global Generic Drug Regulatory Research Fellow

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

will be mentored by senior FDA scientists, pharmacokineticists, chemists, and regulatory reviewers, and will learn to integrate perspectives from diverse scientific disciplines to build a comprehensive

FDA Fellowship - Computational Toxicology

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

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

FDA Fellowship - Mechanistic Modeling and Simulation

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 12 hours ago

have opportunities to: Learn to develop and apply AI and machine learning methods to pharmaceutical manufacturing and product quality challenges. Gain experience constructing and evaluating mechanistic

FDA Fellowship - 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 12 hours ago

. If a need to change the labeling is uncovered as a result of this research project, FDA has new and expedited procedures under OTC monograph reform to initiate an administrative order to make safety

FDA Fellowship - Evaluating Approaches for Synthetic Data Generation and Evaluation in Regulatory Submissions

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

available datasets. Build scientific communication and knowledge translation skills through translating complex computational and methodological findings into accessible findings — including technical memos

FDA Fellowship - Orange Book NDA and ANDA Parenteral Combination Drug Product

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

, Orange Book publication information will be reviewed to support various types of special projects. Learning Objectives: Under the guidance of a mentor you will: Learn the structure and purpose of approved