Medical writing is the activity of writing scientific documentation by someone who is a specialized writer (a medical writer) and is generally not one of the scientists or doctors who performed the research. A medical writer is anyone engaged in communication in the medical or allied professions and sciences. The purpose of medical writing is to have a writing specialist work together with the people who produce the scientific data in order to create documents that effectively and clearly express the messages the data have to tell. The medical writer also serves to make sure that the documents comply with any regulatory, journal or other guidelines in terms of content, format and structure.
Medical writing is a well-established function in the pharmaceutical world, due to the fact that people have begun to recognize that not everyone can write a well-structured document that presents information and tells a message clearly and concisely. It is one thing to put a bunch of data onto a page, it is another thing to do it in such a way that someone not familiar with the data can immediately understand the meaning of the data. With an increasing demand for getting new drugs to the market as quickly as possible, writing documents that can be read and understood quickly and easily has become an ever higher priority. Hence, the growth of professional medical writing.
Medical writing that is sponsored by the pharmaceutical industry and is done by healthcare professionals known as medical writers is either regulatory medical writing or educational medical writing.
Regulatory writing is writing documents for regulatory agencies so that drugs, devices and biologics are approved, and stay approved for marketing to humans. Regulatory documents can be huge and are formulaic; they include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures, and summary documents that summarize and discuss all the combined data gathered in the course of developing a drug, device or biologic.
Educational medical writing is writing documents about drugs, devices and biologics for general audiences,and specific audiences such as professional healthcare audiences. These documents include monographs about a newly launched drug for sales representatives, data presentations at medical congresses, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuting medical education (CME) activities.
Regardless of the type of medical writing being done, it is either done "in house" or it is "outsourced". In-house writing means a pharmaceutical company has its own medical writers who work on the drug products developed by that company. Outsourced writing means the pharmaceutical company hires an external professional medical writer or groups of professional medical writers to draft documents involving their drug products. The external professional medical writer may either be a freelance writer (i.e., a self-employed writer) or a writer from a company that offers medical writing services.
There are several professional organizations for medical writers around the world. These include the European Medical Writers Association (EMWA), the American Medical Writers Association (AMWA) and the Australian Medical Writers Association (AuMWA). The purpose of these organizations is to create a forum where medical writers can meet and share knowledge and experience. They serve to promote career opportunities and professional development of medical writers as well as to promote standards of excellence in biomedical communication. All these organizations offer training in the fundamentals of medical writing.
The following are good places to get more information on medical writing: