Cultivating Passion and Curiosity in Medical Writers: The Need for Dynamic and Agile Training Programs

My journey in writing began in 1999 as a science communicator right after grad school, before moving to regulatory writing in 2005 with minimal formal training. Early on, I was handed the ICH E3 guidance for clinical study reports and had to navigate through it on my own. My tasks varied daily, ranging from clinical data reporting to understanding submission procedures, including physically preparing documents for US Food and Drug Administration submission—the blue pronged folders are memorable. Fortunately, today’s training resources and electronic submissions make the process much smoother.