Compass Consulting

Summary This position will report to the Medical Writing Department Head and will lead scientific, medical and regulatory writing activities for development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs). The professional will also perform the medical writing, QC reviews, and editing of the documents and will be responsible for the management, planning and direction of a team of medical writers. The professional will ensure the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and...