A medical writer is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.
Medical writing as a function became established in the pharmaceutical and contract research organization industry because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science, drives the demand for well written, standards-compliant documents that medical professionals can easily and quickly read and understand. Similarly, medical institutions engage in translational research, and some medical writers have experience offering writing support to the principal investigators for grant applications and specialized publications.
Medical writing for the pharmaceutical industry can be classified as either regulatory medical writing or educational medical writing.
Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. 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 (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.
Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, consumer education and programs and enduring materials for continuing education (CE) or continuing medical education (CME). It plays a very important role in promotion of various pharmaceutical brands both to the HCPs and the consumers. Different types of communication use different media to present the writings.
Other types of medical writing include journalism and marketing, both of which can have a medical writing focus.
Regardless of the type of medical writing, companies either assign it to an in-house writer, or "outsource" it to a freelance or contract medical writer.
Several professional organizations represent medical writers around the world. These include:
- American Medical Writers Association (AMWA)
- Australasian Medical Writers Association (AMWA)
- European Medical Writers Association (EMWA)
- Indian Medical Writers Association (IMWA)
- Chinese Medical Writers Community (CMWC)
These organizations provide a forum where medical writers meet and share knowledge and experience. They promote professional development and standards of documentation excellence, and help writers find career opportunities. All these organizations offer fundamental medical writing training.
Books on medical writing
Stephanie Deming of the Council of Science Editors compiled in 2003 a list of books that might be helpful in medical and/or science writing. In 1978 the BMJ editor Stephen Lock recommended Hawkins's 1967 book Speaking and writing in medicine and 4 other books.
Importance of lucidity
The single most important feature of any article is lucidity. Useful guidelines are to write in fairly short sentences, keeping the words and phrases as simple as possible. Reading the article aloud is a good way of discovering how intelligible it is and some authors normally write their first drafts by using a tape recorder. It is also helpful to read articles written by masters of medical style, such as Richard Asher and William Boyd.
- Creswell, J.W. (2008). Educational research: Planning, conducting, and evaluating quantitative and qualitative research (3rd). Upper Saddle River, NJ: Prentice Hall. 2008, p. 300. ISBN 0-13-613550-1
- "Professional Medical Writing". Archived from the original on October 29, 2016. Retrieved October 29, 2016. CS1 maint: discouraged parameter (link)
- "Adaptive Clinical Trials for Overcoming Research Challenges". News-medical.net. Retrieved October 29, 2016. CS1 maint: discouraged parameter (link)
- "The Science Editor's Bookshelf: Some Favorite Resources of CSE Members" (PDF). Science Editor, July–August 2003. 26 (4): 111–117.
- Lock, Stephen (13 May 1978). "In their own write". Br Med J. 1 (6122): 1267–1268. doi:10.1136/bmj.1.6122.1267. PMC 1604607.
- Lock, S. (1970). "Writing for a journal". British Journal of Anaesthesia. 42 (9): 764–767. doi:10.1093/bja/42.9.764.