An experienced regulatory affairs professional and medical writer with a strong background rooted in science and research, Lee is recognized for her ability to process and summarize complex information, which allows her to effectively communicate key elements of each product in concise, easily understood briefing documents.

Approach

Lee’s approach to writing briefing documents starts with understanding the science and data behind the product. She leverages her scientific and regulatory background with her technical writing and communication skills to prepare clearly written FDA Advisory Committee briefing documents and panel packs. Using her background in interdisciplinary and translational research, she efficiently collaborates with project teams to ensure that the scientific story is conveyed, while highlighting key messages.

Background

Lee’s interest in product development began in graduate school as a translational medicine fellow, working on projects ranging from basic science to clinical research. Wanting to be more involved in bringing innovative treatments to the market and to patients, she transitioned to a career in regulatory affairs and medical writing. She has experience in a wide range of therapeutic areas for both medical devices and pharmaceuticals, and enjoys working on diverse teams. Lee earned the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society and holds a PhD in biomedical engineering from the University of North Carolina at Chapel Hill and North Carolina State University.

Special Interests

Lee is a supporter of several nonprofit and community organizations, including ROCovery Fitness and Culture Mill. In her spare time, she enjoys kayaking, long-distance running, and training for triathlons.