Members of the task force strongly believed that professional medical writers can improve the quality of scientific papers, but that fact is often not recognised outside the medical writing profession. At least in part, this is because of a perception that ghostwritten papers may have been inappropriately influenced by pharmaceutical companies. One theme that emerged strongly from the discussions was transparency. Members thought it very important that the existence of a ghostwriter should always be made clear to the reader. Another strong theme was the importance of defining in detail what practices relating to ghostwriting are ethical, and what practices are not. This definition of ethical ghostwriting should be widely known, and unethical ghostwriting should be strongly condemned. Use of the term 'ghostwriting' itself was questioned. Members of the task force felt that use of a more neutral term should be encouraged. The task force suggested various activities for ensuring that above the objectives could be met, including discussions with other interested parties, such as journal editors and pharmaceutical companies, educating medical writers about ethical practices, further research into ghostwriting, and developing guidelines for ethical medical writing.

The Harold Swanberg Distinguished Service Award, named in honor of one of the founders of AMWA, is presented to an active AMWA member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. The Swanberg Distinguished Service Award is presented during AMWA’s Medical Writing & Communication Conference.

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly recognized. The American Medical Writers Association (AMWA) formed a working group in 2020 dedicated to defining the value that regulatory medical writers contribute. The purpose of this article is to demonstrate the value that regulatory medical writers bring to the drug development and approval processes and to explore the ways in which efficiencies in regulatory writing can be increased. Current models for success provide guidance on training to help medical writers achieve their full potential, but obstacles and barriers to medical writing efficiency and document quality remain. Surveys developed by the AMWA working group revealed that (1) regulators who review clinical documents believed that regulatory writers improve document quality and (2) writers are frequently recognized for leadership and collaboration. Maximizing medical writing value requires thoughtful leadership and investment in training that includes both technical knowledge and soft-skill proficiency.

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In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s perspective. We invited reviewers at regulatory agencies to participate in an anonymized survey to evaluate the effect of document quality on the regulatory review process, assess awareness among document reviewers of the contribution of medical writers to the quality of regulatory documents, and identify current strengths and opportunities to optimize document quality. This article shares the survey results and discusses their implications for document quality, their impact on the regulatory review process, and the skills medical writers need to develop to bring value to this process.