FDA/CDER Office of Business Informatics
A fellowship opportunity is currently available with the Office of Strategic Programs (OSP) within the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). The Risk-Based Quality Assessment & Inspections Fellowship project is administered by ORAU for the Oak Ridge Institute for Science and Education program.
The objective of this research project is to transform drug quality review and inspection management processes by infusing modern risk-based regulatory approaches and tools in submission review, manufacturing facility assessment, and surveillance of marketed drugs and therapeutic biologics.
The selected participant will support the implementation, expansion and evaluation of the informatics quality platform by utilizing methods from the fields of computer science, decision science and operations research. One specific area of focus is identifying means to improve data quality of a facility or process. The participant will apply modern tools for decision analysis, and visualization of big data and data management solutions to analyze research and develop the application to FDA's regulatory review processes.