48 requirements-engineering "https:" "https:" "https:" "Universidade do Minho CTAC" research jobs at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

technology, which has been identified as a rapid microbial method that aligns with current pharmaceutical industry trends, to better support submissions utilizing this approach. Researching collaboratively

FDA Postdoctoral Fellowship / Research Fellowship: 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 | 17 days ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Postdoctoral Fellowship in New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

outcomes and optimizing model performance. The participant will help prepare reports, presentations, and publications advancing the regulatory application of MPS technology and may join in developing

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

: The participant will receive a monthly stipend commensurate with educational level and experience. Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only

FDA Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago

commensurate with educational level and experience. Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago

to post approval Pregnancy and Lactation Studies.  Specifically, the focus is on evaluating the pregnancy and lactation postmarketing requirement studies issued between 2007 and the present to identify

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

products is labor intensive and may involve judgment over application procedure and body surface area estimation. To overcome such challenges, this project attempts to approach with AI model(s) in

FDA Fellowship - Large language Models in Post-Market Surveillance of Drugs Using Social Media

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago

to align your interests with areas of research need to OSE (e.g., drug safety, substance use disorders, pharmacovigilance, pharmacoepidemiology methods development). As an OSE-trained fellow, at

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

: The participant will receive a monthly stipend commensurate with educational level and experience. Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

: The participant will receive a monthly stipend commensurate with educational level and experience. Citizenship Requirements: This opportunity is available to U.S. citizens only. This program, administered by ORAU