By Adriano Vissa
This month, the LSCDS Alumni Spotlight Series features medical writers. Please follow the link at the bottom of this article to see their stories. But first, let’s explore the question: What is medical writing? While many graduate students in the life sciences have traditionally been aware of industry opportunities in fields such as medical affairs, regulatory affairs or business development, medical writing is increasingly becoming a career path that MSc and PhD graduates are considering. In fact, the importance of medical writing is underlined by its contribution to many levels of a company’s operations, including the three fields mentioned above. Whether it’s producing non-promotional pharmaceutical communications in support of a medical affairs team, documents for submission to regulatory approval agencies, or educational material to create awareness and adoption of a technology or treatment, medical writers are the cornerstone of a scientific enterprise’s communications strategy.
While the responsibilities of a medical writer may be quite diverse depending on the company and industry, in general medical writing falls into a few broad categories:
- Regulatory – This type of medical writing includes preparation of documentation for regulatory submission of pharmaceuticals, medical devices, and more recently, biologics. They involve communicating information in the form of various reports, such as clinical studies, patient informed consent forms, investigator brochures and summary documents. A standard summary report format used across Canada, The United States, Europe and Japan is the Common Technical Document (CTD), which is divided into specific modules aimed at facilitating the approval process.
- Educational – The production of documents designed to be of non-promotional educational value fall under this category. Many companies produce this kind of material targeted to health care practitioners (HCPs) and key opinion leaders (KOLs) relevant to their particular medical focus. This kind of work can include a wide array of communications, from data sheets for newly launched products, to conference presentations, scientific journal articles, and consumer education programs.
- Marketing and Advertising – Whether a company that operates in the medical space can market its products directly to consumers depends highly on the product category and the laws of the country in which it does business. For example, the promotion of pharmaceuticals to consumers through traditional and digital channels is illegal in Canada, but for the most part permitted in the United States. This kind of marketing communications nevertheless often takes on an educational and professional tone, aimed at describing to patients or customers how their quality of life can be improved through the use of a drug or medical product.
- Journalism – Although not traditionally considered a medical writing profession, some journalists focus their reporting on scientific or medical topics. In order to produce consistent articles of quality, they must have knowledge of key issues and current events in science, medicine and the pharmaceutical industry, particularly as they relate to public policy and the well-being of a country’s citizens.
A medical writer can either be a full-time employee of an organization, or an independent freelance writer. The majority of medical writers are employed by pharmaceutical companies, medical device companies, medical education companies, and contract research organizations (CROs). CROs help pharmaceutical companies navigate the complexities of the multi-level drug development process. A medical writer working for a CRO may produce material for a number of drugs across several therapeutic areas. Other medical writers may become an expert in one or two therapeutic areas over time. There a truly a multitude of possibilities and learning opportunities in this fast-paced and challenging career.
Please read our latest Alumni Spotlight article.
Useful resources for aspiring medical writers:
- The American Medical Writers Association (Canada Chapter)
- The HittList – A database of medical writing opportunities, both in-house and freelance
- Examples of Contract Research Organizations
Written by LSCDS Exec Member Adriano Vissa
Adriano is a 5th year collaborative PhD candidate in the Department of Biochemistry and the Institute of Biomaterials and Biomedical Engineering. He also holds a Bachelor of Commerce from McGill University and is interested in combining science and business in a career in scientific commercialization, marketing management or consulting.