Regulatory Writing v Medical Communications: What is the difference?

Many medical writers don’t actually know that there are different fields within medical writing! I was trained in regulatory medical writing, cutting my teeth on clinical study reports (CSRs), investigator brochures, safety documents and narratives. Certain personality types gravitate towards regulatory some medical communications, and some more marketing-focused medical writing. In my experience, the more introverted, reserved and highly analytical and scientific personalities work in regulatory, whereas the extroverted, more flamboyant yet science-oriented personalities shine in medical communications. But what is the difference?

The core of regulatory work is focused on reporting and describing results of clinical trials and all of the background, pre-clinical and safety information surround them. There is very little creativity involved in this side of medical writing. Most regulatory documentation comes together to form the electronic common technical document (eCTD), which consists of modules, sections and documents used by a pharmaceutical company applying to various regulatory agencies (in the European Union, Japan and the United States) for a marketing authorisation of a medicinal product for human use. These documents are confidential and not open to the public.

CSRs form the backbone of any medical communications programme. Medical communications take information from CSRs to create manuscripts for publications in journals, abstracts and posters for presentations, and PowerPoint slides to deliver new data. There is an array of medical communications documents, many of which will end up in the public domain, through being published or used as marketing collateral. This writing requires varying levels of creativity because trial data and other information must be weaved together in different formats for their audiences, which may range from scientists and researchers to physicians and hospital formulary staff. Indeed, with creative digital media becoming a major player in our industry, various companies are focusing on developing digital media strategies to further theirs or their clients’ marketing and communications ambitions. Examples include more web content through web copy and blogs, medical social media, to interactive eLearning platforms for different patients and healthcare professionals.

If you want no frills medical writing with a steady stream of work working on one document for long periods of time, then regulatory is for you. If you want to get creative, have more “ownership” of your work and see it “out there”, then medical communications and marketing is the avenue you need to explore!

If you would like to learn more about how we help medical writers get started and progress in our industry using our intensive medical writing training programme, or simply how we advise on the path to take, be it regulatory writing or medical communication, please do get in touch!