Non-clinical health writing

Abstract

We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed documents, and following specific regulations and guidelines. These skills should be transferrable to other domains, but which ones and how? This issue, ‘Nonclinical health writing’, describes areas tangential to medical writing in which medical writers can work. The issue begins with three articles on veterinary medical writing.Nicola Parry describes opportunities in veterinarywriting, andSusanneGoebel-Lauth outlines the veterinary regulatory structure and dossier content requirements in Europe. Anna Romero rounds off this section with an article on the specialty of translation in veterinary medical science. Cosmetic products are another little-known area that could benefit from the help of a medical writer. As Lorine Preud’homme and colleagues explain, new regulations harmonising the rules for cosmetic products, their registration, and testing were recently put into place. Medical writers are well-positioned to prepare the dossier for cosmetic products because we are familiar with presenting necessary information, formulating key messages, and telling a product story with a clear, complete, and consistent approach. Chemical products also have very specific regulations and documents that could be managed well by an experienced medical writer. Lorraine Tilbury and Phillipe Adrian first describe REACH chemical dossiers, through which chemical substances are approved in Europe, and in a second article, Dr Tilbury explains pesticide regulations and the preparation of pesticide dossiers in Europe. She explains that because these documents have many similarities with clinical regulatory documents, with a little training, a medical writer could easily cross over into these fields. Finally, although nanomaterials are currently covered by existing regulations for small-molecule pharmaceuticals and medical devices, their increasing use may lead to specific regulations or at least, as Simone Lerch puts it, to ‘nanomedical writing’ as a specialisation in the medical writing profession. Alisa Davis next tells us about medical writing for in vitro diagnostics, which are used to evaluate human samples for biological analytes. She describes how this area will become increasingly important for pharmaceutical writing, although medical writers should be aware that the regulations and writing for in vitro diagnostics differs from those for pharmaceuticals. Linked to this are bioanalytical reports, which describe drug concentrations in biological samples and are used as the basis for toxicokinetic and pharmacokinetic evaluations. Alexander Nurnberg describes these and how medical writers can assist in their preparation. He concludes that due to a good overview of the drug development process, medical writers have valuable expertise in placing bioanalytical reports in the perspective of a clinical trial or submission package.