29 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "https:" "University of Kent" 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 | about 12 hours 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 Clinical Pharmacology / Model Informed Drug Development

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

the end of the program, you will understand principles of dose selection and optimization across drug development stages and gain insight into FDA decision-making for complex modalities. Skills developed

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

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

the guidance of the mentor, you will learn state-of-the-art technologies and develop novel technologies for feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal antibody

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 12 hours ago

). The project is to develop liquid chromatography-mass spectrometry (LC-MS) methods for the analysis of nitrosamine impurities in drug products and apply the developed and validated methods to screen

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

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

disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

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

generic drugs. This work covers more than just medicines. Research Project: The fellow will participate in a research project to develop optimal cell-based gene reporter potency assays for FSH, LH, and hCG

FDA Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

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

generic drugs. This effort covers more than just medicines. Research Project: You will cooperate in developing bioassays to assess the potency of fertility hormones. This will include follicle stimulating

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

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

generic drugs. This effort covers more than just medicines. Research Project: With the development of Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance, the Office of Quality

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 12 hours ago

role in the development of dental and periodontal diseases. The project’s goal is to provide scientific updates for testing methodology employed to assess the effectiveness of antigingivitis/antiplaque

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 12 hours ago

trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning