Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the medical writer can arrange in any configuration. By structuring and standardising clinical and regulatory content, the pharmaceutical industry can shift from a document-based to a content-based approach. This transition will require adopting structured content management tools and common structures, and standardising content. In tandem, medical writers must evolve their skillset and ways of working, primarily through planning and producing content and adopting structured content authoring practices to facilitate content creation and reuse. This article introduces structured content authoring and outlines how the medical writing role in the pharmaceutical industry may soon evolve.

Medical Writing. 2023;32(3):32–37. https://doi.org/10.56012/xafs6978