Managing protocol development with international teams: Soft skill perspectives from a global team of protocol writers

Clinical trial protocol development forms part of the critical path for launching a trial, which means timelines are tight and progress must be fast and sustained throughout the protocol’s development. In order to be successful, medical writers require well-developed soft skills to meet the needs of the trial team and to produce a high-quality protocol. We focus on five critical soft skills that are essential for medical writers working with international teams: critical thinking, leadership, communication, teamwork, and adaptability. Based on our experience as a global team of protocol subject matter experts from Asia-Pacific, Europe, India, South Africa, and the US, we also discuss soft skills that are important for working with team members across different regions.