Developing New Talent in Regulatory Medical Writing: AMWA Apprentice Program Framework

During the fourth annual Medical Writing Executives Forum in 2022, medical writing department leaders began discussing the development of a framework for a regulatory medical writing apprentice program. Based on survey results presented at the Forum, fewer than half of the respondents’ organizations had an apprentice program in place; however, most felt it would be useful to have a standard framework for such a program, either to refine existing programs or to develop a new program. A working group was established to create a framework, drawing on initial discussions held at the Forum and the practical experience of the workstream members. The resulting Apprentice Program Framework provides resources, strategic documentation, and guidelines to create the foundation for a successful medical writing apprentice program, adaptable to a variety of settings. These resources include the following topics: job leveling definitions (including the definition of a “Level 1” medical writer, who has minimal or no regulatory medical writing experience, and is the intended level for participation in an apprentice program), a business case presentation, a list of core training topics, recommendations for effective learning methods, guidance around program structure and duration, and a recruitment toolkit. This framework is the first industry-standard program designed to develop a pool of well-trained medical writers in an adaptable and scalable manner.