29 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "https:" "University of Kent" uni jobs at Center for Drug Evaluation and Research (CDER)

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: Despite tremendous strides in pediatric drug development prompted by the Best Pharmaceuticals for Children Act and

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

decision-making. This educational and developmental program provides you with training opportunities to continue your education and research while enhancing your professional skills. You will also become

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 10 hours ago

. Offices within OPQ are collaborating to develop and validate a universal gas chromatography-mass spectrometry (GC-MS) method to assess drug products for benzene contamination. This project aims to develop a

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours 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 Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

patients is challenging. The objective of this project is to develop a pediatric oncology database by collecting data from pediatric study protocols, regulatory marketing applications and FDA review

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 10 hours ago

drugs, including biological therapeutics and generic drugs. This effort covers more than just medicines. Under the guidance of the mentor, the participant will develop aerosol/particle analytical methods

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours 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 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 | about 10 hours 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

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

products and development programs. Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results

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 | about 10 hours 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