75 data-"https:"-"https:"-"https:"-"https:"-"BioData"-"BioData" positions at Center for Drug Evaluation and Research (CDER)

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 | about 4 hours ago

website for information about the valid immigration statuses that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 hours ago

, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the

FDA Fellowship - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

-on training to retrieve data from relevant FDA databases and tools. Under the guidance of mentors, you will learn about regulations, policies, and procedures pertinent to postmarketing drug safety surveillance

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

, data analysis, and regulatory submission evaluations to identify knowledge gaps and establish best practices for assessment. You will analyze clinical trial datasets to characterize dose-response

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 3 hours ago

dose selection based on adult data and patient-specific factors. Specifically, the fellow will: Survey clinical development programs for IBD products, focusing on dose-selection strategies for adults and

FDA Postdoctoral Fellowship in New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 hours ago

results, compare MPS-derived profiles with clinical data, and assess translational concordance. These efforts will include identifying factors that contribute to variability between in vitro and clinical

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 hours ago

computational research and communicating scientifically. The training objectives of this research project will include: Understanding and extracting relevant data from the literature and synthesizing available

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 hours ago

nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses that are acceptable

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

review process. Learning Objectives: Under the guidance of the mentor(s),you will develop the following skills during the fellowship; (1) data collection and analysis, (2) clinical pharmacology and

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

competencies in research methodology, data analysis, scientific presentation, and manuscript writing skills that support career advancement in regulatory science, pharmaceutical development, or academic research