Nancy has over 17 years of regulatory medical writing experience, during which time she has served as a project manager and/or lead writer for multiple marketing applications (NDAs/BLAs/MAAs). As a member of the Syner-G Executive Leadership Team, she leads the Medical Writing Services group. Her team of experienced medical writers and quality control specialists provide support for a variety of regulatory documents across a wide range of therapeutic areas and all phases of development (including Clinical Study Reports, protocols, Investigational Brochures, safety narratives, and high-level documents such as integrated summaries of safety and efficacy, Module 2 clinical summaries and overviews, and FDA and Advisory Committee briefing documents).