Maximizing the Value of Regulatory Medical Writing

    Maximizing-the-Value-of-Regulatory-Medical-WritingAre you a regulatory medical writer who is concerned about proving your mettle?

    Regulatory medical writers play a critical role in the drug development and approval processes. Yet their role is often misunderstood and undervalued.

    In 2020, AMWA created a working group to define and quantify the value of medical writing in the regulatory environment and has since been exploring ways to highlight the contributions of regulatory medical writers and demonstrate their value

    Surveys conducted by the working group showed that regulators who review clinical documents largely understand and appreciate the value of the contribution of medical writers to the documents they review. However, some members of the drug development team in which medical writers work do not understand what they do or value the expertise medical writers bring to the process.

    The working group concluded that proving the value of medical writers is going to take leadership and investment in training and skills that improve the quality of clinical documents. In addition, it will require an increased focus on the technical knowledge and soft skills that make medical writers essential members of the pharmaceutical team.

    What Is a Regulatory Writer?

    In an AMWA Journal article titled “Optimizing the Value of Regulatory Medical Writers,” members of the AMWA Value of Medical Writing Working Group define regulatory writers as “those who primarily prepare regulatory documentation supporting ongoing clinical trials (eg, clinical study protocols, investigator brochures, investigational new drug [IND] applications) and the reporting and submission of trial results to regulatory agencies (eg, clinical study reports and Module 2 clinical summary documents for marketing applications).”

    Pharmaceutical companies need communication experts to facilitate the process of developing and bringing new drugs and devices to market. This work requires a specialized skill set that bridges scientific and communication realms. 

    How can we create a shared understanding of the value and role of regulatory writers? It starts with understanding what it takes to be an excellent medical writer.

    The Competency Model

    An industry group of medical writers created a Medical Writing Competency Model that serves as a blueprint for the essential functions of regulatory medical writing. This model describes 5 core competency domains.

    1. Gathering
    2. Evaluating
    3. Organizing
    4. Interpreting
    5. Presenting

    These 5 domains are also essential to the Medical Writer Certified (MWC®) exam. 

    Of course, regulatory medical writers want to be more than competent; they strive for excellence. 

    Obstacles to Overcome

    Studies on scientific publishing found that a number of barriers exist to optimizing the role of medical writers. The AMWA Journal article cites a lack of adequate writing skills and strategy, insufficient time, and insufficient training. 

    Medical writers need training in organizing documents and making them readable and comprehensible. When regulatory writers have insufficient training or experience, the process of reviewing and approving new medicines can be slowed. 

    Creating excellent documents takes time and involves input from multiple sources. However, timelines for these complex documents are not always sufficient for medical communicators to hone the messages and ensure accuracy. 

    The review of documents by subject matter experts during the authoring process can help ensure quality and accuracy. However, it can be difficult and time-consuming to secure the input of experts. 

    Many of these obstacles can be overcome by training medical writers in the soft skills that are vital in today’s workplace.

    Leadership and Training

    As in most professions, it is increasingly important to be flexible and knowledgeable across multiple content areas. David Epstein, author of Range: Why Generalists Triumph in a Specialized World, writes, “The more varied your training is, the better able you’ll be to apply your skills flexibly to situations you haven’t seen.” 

    When regulatory writers understand and participate in writing across all phases of drug development, their contributions become indispensable.

    Soft Skills

    Technical knowledge and skills alone are not enough to thrive in today’s workplace ecosystem. Soft skills (sometimes called transferable skills) are the qualities that make someone an excellent collaborator, leader—and often a good person. Soft skills include qualities such as

    • Being a team player
    • Cultural competency and sensitivity
    • Ethics
    • Etiquette
    • Interpersonal skills
    • Leadership 
    • Positive attitude
    • Self-confidence
    • Time management
    • Work ethic
    • Written and spoken communication

    An analysis of ads for regulatory medical writers confirms that employers want candidates with solid soft skills. These ads often mention behavioral skills such as leadership, team working, networking, and organization and social skills like communication.

    How do medical writers who have the right blend of technical and soft skills prove their value in the workplace?


    Metrics can convince stakeholders of the value medical writers bring to their teams. In AMWA’s webinar, Metrics: Proving Our Value, Daniel Augusto Muriel Ramirez, part of the Business Operations Support Team for Medical Writing at MSD in Bogotá, Colombia, explores how to measure operational productivity, document quality, cycle times, and employee performance. 

    The Value of Well-Being

    Metrics are a starting point for proving the value of medical writing. However, the ultimate measure is successfully moving drugs, devices, and diagnostics from development into the hands of the people who need them. 

    The next generation of regulatory medical writers is poised to receive the training, mentorship, and support they need to support this ultimate goal. As they master the technical and soft skills needed to grow in their roles, they will step into leadership positions and collaborate with teams that are changing the face of medicine.


    August 7, 2023 at 9:00 AM

    American Medical Writers Association

    AMWA is the leading resource for medical communicators. The AMWA Blog is developed in partnership with community members who work every day to create clear communications that lead to better health and well-being.