Dawn Luciano

Dawn Luciano is an experienced medical writing professional with a comprehensive background in clinical and regulatory documentation across various therapeutic areas, particularly in rare and life-threatening diseases. As the Principal at Luciano Medical/Safety Writing Pharma Consulting, LLC since December 2014 and a Principal Medical Writer at ViroPharma Incorporated since 2008, Dawn has prepared a wide array of clinical documents for regulatory submissions, including INDs, NDAs, and MAAs, ensuring compliance with FDA, EMA, and Health Canada guidelines. Previous roles include Independent Writing Consultant at Precision Research, Inc., and Bracco Diagnostics Inc., as well as managerial positions at BioPharm/IBAH, where responsibilities ranged from clinical report management to quality assurance and safety analysis. Dawn holds a Bachelor of Science in Nursing from Indiana University.