FDA Fellowship in Program, Policy and Operational Analysis

This project will support and analyze a broad range of proposed and current CDER programs and policies by conducting quantitative and qualitative analyses to address operational needs. OPSA assesses the impact and efficiency of CDER initiatives and programs, designs and implements new programs, advances structured benefit-risk assessment in regulatory decision making and evaluates key business processes using evidence-based approaches that assess the value of each step and leads to sustained practical solutions for complex problems. OPSA’s work informs and influences organizational strategy and decision-making by senior management and serves as key input into decision-making around the related program, policy or operational issue.

Under the guidance of a mentor, the participant will be trained on: conducting background research related to a policy or data need identified by the mentor, participating in the development of research methodology and project planning through contributing to relevant research, compiling and analyzing relevant qualitative and quantitative data, and synthesizing and presenting findings. This project is critical to our public health mission and the training will prepare the participant for a successful career transition into regulatory science research.