Julie has over 35 years of experience in US and International regulation and policy within multiple disciplines: pharmaceuticals, medical device, and biologics. Expertise includes regulatory compliance and strategy, clinical operations, quality assurance, regulatory operations, clinical research development, and departmental management. She has an extensive background in Institutional Review Board activities with both the University of Cincinnati IRB as the IRB Director and Chair for the Social and Behavioral IRB. She has worked with Schulman IRB. She has worked with both industry, academics, and government agencies to train and guide research investigators on Good Clinical Practice in pharmaceuticals, medical devices, and human participant protections. Julie received both her undergraduate degrees in microbiology and nursing from the University of Florida. She received her master’s in public health from the University of South Florida in epidemiology and biostatistics. Her epidemiology coursework continued at the Johns Hopkins School of Public Health. She received and has maintained her Regulatory Affairs Certification (RAC) since 2015. Julie is a member of Regulatory Affairs Professional Society (RAPS).