69 machine-learning-"https:"-"https:"-"https:"-"https:"-"https:"-"https:" positions at Center for Drug Evaluation and Research (CDER) in United States

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 2 days ago

or risks from sources other than clinical trials. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning

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 | 2 days ago

be utilized to test unstressed and stressed FSH, LH and hCG samples, comparing their performance with the current in-use rat potency assays. Learning Objectives: During the appointment, you will have

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

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

mentor, you will engage in cutting-edge research activities to learn how to develop and implement artificial intelligence-enabled systems for surveillance and inspection. Key activities will include

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 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

early. Learning Objectives:  Under the guidance of the mentors, you will have the following learning outcomes; Learn the FDA database navigation system Learn how the biomarker assists the drug development

FDA Clinical Pharmacology / Model Informed Drug Development

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

regulatory science and prepare the next generation of regulatory scientists. Learning Objectives: The fellowship combines structured learning with applied regulatory research. You will attend seminars

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

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

communicated in FDA-approved product labeling, comparing review findings with final labeling language to identify alignment patterns and improvement opportunities. Learning Objectives: Your educational training

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

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

understanding of HLA-restricted T-cell activation. Learning Objectives: Under the guidance of a mentor, you will gain experience in and learn to: Identify Impurity-Derived Neoepitopes via Immunopeptidomics Define

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

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

or limited multivariate analysis. However, the increasing dimensionality and complexity of analytical data demand AI/ML-based frameworks capable of learning nonlinear, high-dimensional relationships between

FDA Over the Counter Drug Monograph Research Fellowship

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

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and