Medical Writing Apprentice Program Framework Overview

The AMWA Medical Writing Apprentice Program Framework is the first tool of its kind to support companies looking to set up a program, develop new talent, and grow a pool of well-trained medical writers. Developed through extensive research and benchmarking in the industry, the Framework provides resources, strategic documentation, and guidelines to create the foundation for a successful medical writing apprentice program. Learn more about the development of the framework in the AMWA Journal article Developing New Talent in Regulatory Medical Writing: AMWA Apprentice Program Framework.

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Key Materials in the Framework

Designed to help standardize training programs across the industry for professional development of regulatory medical writers, the materials in the framework can be customized and deployed as needed to help organizations develop and grow the next generation of medical writers. The materials are organized into the following categories.

Job Leveling/Job Descriptions
The AMWA Job Leveling framework seeks to provide the industry with a broad foundation to assess the level and skill set of an individual medical writer. The Job Leveling framework establishes a common ground as to what medical writers should be expected to be able to do at a given stage in their career, based on a writer’s educational and professional background and experience.

Core Training Topics and Trainings
Recommended training topics for Level 1 regulatory medical writers

Learning Methods
Description of learning methods to consider for apprentice programs targeted at Level 1, including the benefits and limitations of these methods.

Structure and Duration
Example structure/duration for an apprentice program starting at Level 1.

Business Case
Most companies require a business case or similar for investments such as apprentice programs. The module includes customizable content to provide a sound rationale and concrete reasons to support the value of having an apprenticeship program in an organization. It also discusses how to calculate return on investment, financial benefits of an apprentice program, and soft benefits such as improving morale and increasing diversity. 

Recruitment Toolkit
Tools for recruitment, including interviewing questions to target the desired skillset among Level 1 candidates who do not have medical writing experience.

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Background on the AMWA Apprenticeship Program Framework Initiative

The demand for experienced medical writers (MWs) is at an all-time high, with forecasts predicting a doubling of regulatory medical writing needs over the next few years. Medical writing leaders are grappling with how to meet demand and are increasingly considering apprentice programs to develop their own talent.

Recognizing the need to steadily grow the talent pipeline, the American Medical Writers Association (AMWA) initiated efforts to address these challenges. During the 4th Annual Medical Writing Executives Forum in 2022, approximately 50 medical writing executives convened to discuss the need for apprentice programs. A key takeaway was the consensus on the importance of having a standardized framework to guide the development of these programs.

This journey began with a survey conducted by AMWA’s Executives Advisory Council to explore the current landscape of apprentice programs and assess interest in a unified approach. The survey targeted professionals responsible for leading or developing medical writing teams across a variety of organizational types, including pharmaceutical, biotech, CROs, and consultancies. It revealed that less than half of the respondents’ organizations had formal apprentice programs, yet most recognized the value of a standardized framework to refine or develop these initiatives.

The survey and subsequent discussions highlighted the importance of equipping new MWs with document-specific knowledge, writing skills, and drug development insights, while also addressing potential gaps in leadership and collaboration training. These findings led to the formation of a working group, which has focused on creating adaptable resources to help medical writing departments establish scalable apprentice programs tailored to their organizational needs.

Acknowledgements

Special thanks to the Apprenticeship Program Framework Working Group for providing their time, expertise, and support for the creation of these resources.

Oversight Group: 
Julia Cooper
Julia Forjanic Klapproth
Jeanette Towles
Joan Affleck

Job Leveling Team: 
Laura Sheppard (lead)
Angela Burnett
Janice Worley
Jimmy Zhang
Gina Schweizer
Kim Jochman
Renee Primus
Marta Mas
Garima Pallavi
Andriana Papaconstantinou

Recruitment Team: 
Rona Vasey (lead)
Brian Geldziler
Lynne Munno
Jennifer Meis

Business Case Team: 
Sujata Shah (lead)
Mark Bowlby
Julia Forjanic Klapproth
Gretchen Griffin
Rona Grunspan
Keisha Smith

Core Topics: 
Linda Yih

Learning Methods, Program Structure & Duration: 
Kim Jochman