What is Medical Writing?

Unfortunately, the term “medical writing” suffer from imprecision and vagueness. This, along with the ignorance of the general public about the profession, make it necessary to refine and define the functions and contents of this activity.

Generally, the drafting of medical texts refers to the activity of producing scientific documentation (articles, abstracts, reviews, posters, slides sets, etc.) by a specialized writer: the medical writer. However, this scientific production focuses primarily and to date in the areas of medicine, biomedicine, pharmacology, biology, etc., that is, in the areas of knowledge generally associated with life sciences. It is uncommon to find specialized science writers in other science fields, such as geology, physics or mathematics. In these areas, the scientists themselves are the ones who are usually responsible for the drafting of the documents they need.

The figure of the medical writer is quite unknown, and although its activity is not by itself new, its consideration as a profession is somehow recent, especially in countries like Spain. Although it is a thriving profession in sectors such as pharmaceuticals, health communications or specialized publishing, even within these areas the main functions or document type that benefit from this specialized work are highly unknown.

The figure medical writer was established in the pharmaceutical world, mainly the English speaking one, because the pharmaceutical industry recognized that it takes a special skill to produce well-structured documents that present information clearly and concisely. There are a growing number of new drugs that need to undergo increasingly complex clinical trials, and the regulatory procedures leading to their market approval have being also growing in complexity. This need for clear articulation of medical science prompted a demand for well written documents that were consistent with established standards. This, the medical and scientific community could read them easily and quickly. Medical writing also applies to the grant application and the publication of data in biomedical journals.

The functions of the medical writer are diverse. The medical writer is a specialist that describes the results of biomedical research in which usually did not participate. A medical writer works closely with physicians, pharmacists, scientists and other experts in the field, who designed and conducted the research, that is, with the sponsors and researchers. The objective is to convey effectively and honestly the results, the product application, and other relevant medical or scientific information

Another function of the medical writer is to ensure that the written document meets the requirements established, either by regulatory agencies or by the scientific journals to which it is submitted.

They are very different types of texts written by a medical writer: clinical trial protocols, manuals for researchers, clinical trial reports, common technical documents, etc. But there are two types of documents that occupy most of the medical writer´s time, especially of those writers who work as freelancers: original articles and review articles.

The management of the articles publication (submission to the journal, article formatting according to the specifications of the journal, corrections tracking, etc.) is also a work usually done by the medical writer.

On the shoulders of the medical writer also lies an important ethical responsibility. The writer is responsible for delivering to the study's authors and sponsors a manuscript that accurately reflects the results the study, make sure that the discussion of the results has been made following the established guidelines, and that the whole process was carried out in the most honest way possible.

The field of medical writing is broad. The medical writer prepares documents necessary for the dissemination of scientific information. It is also his role to ensure that the documents produced meet current regulations, the instructions of the journal to be published, and, in general, the patterns for content, format and structure accepted by the scientific community.

This multifaceted scope makes it possible to distinguish, broadly, between medical writing for scientific communications, medical writing for drug registration, and medical writing for health divulgation to the general public.

Thus, for the pharmaceutical industry, medical writers can be classified within two main types:

The regulatory medical writer, who is responsible for the creation of the documents required by regulatory agencies and health authorities for the approval of a drug, device or biological product. Normative documents can be very broad, and are usually formulaic. They include clinical protocols used in the study, reports regarding results, informed consent forms for patients, investigator brochures and summaries. This documentation collects and analyzes the data gathered by a company in the course of the trial.

The educational medical writer, who is responsible for writing documents on a drug, device or biological product to the general public, or for specialized audiences such as life sciences and health professionals. This area includes sales documentation for newly launched drugs, presentation of results at medical meetings, articles for specialized peer-to-peer journals, and educational programs in both public and private sectors.

Other types of medical writing include journalism and marketing, which may require documents with a scientific approach, and need to be drafted by a trained professional.

Whatever the type of medical writing, companies often assign this function to an in-house writer (large pharmaceutical companies often have medical writing departments), or outsource the function to a contract medical writer.

In short, medical writing is, since long, a function clearly established in the pharmaceutical world, as it increases the speed and quality with which the results of research projects are published.

The medical writer needs to have some very specific skills and training. He or She combines its scientific and technical expertise and research experience with the ability to present the information appropriately, adapting the language level to the public for which the information is intended. Not everyone is able to write complex scientific documents in a clear and structured fashion, and to convey the message of those documents effectively.

Usually, the medical writer is in possession of a degree in life sciences (biology, biochemistry, physiology, chemistry, medicine, etc.), even some companies require a PhD in science for the job. However, it is not uncommon to find medical writers who started their training in the areas of languages, and then drifted to the health sciences.

It is not essential to have a medical degree, but it is important to have a solid basic knowledge of human physiology and biology to be able to understand the information gathered for the writing. It is also indispensable requirement to have very good writing skills, and know how to handle easily word processor software. Attention to detail is essential when reviewing and editing documents, and when identifying the main points in the often maelstrom of information provided. The communication and teamwork skills are also important, because a medical writer is often part of a multidisciplinary team, and need to keep in good terms with people of different areas and backgrounds.

The medical writer should be prepared to write different kinds of scientific texts, accommodating the needs of the clients and the public to whom the information is intended. In addition to basic training, it is required to have competence and skills in information search, analytical and conceptual thinking, and a great collaboration capacity.

And of course, you learn to write by writing. Ongoing training is an essential part of the medical writer's professional life.

In summary, medical writing is the production of scientific documents, usually in the field of life sciences, either in aspects related to research, regulation or divulgation. The specialized professional who performs such activity is the medical writer.

Bibliography:

• Themedical writing. European Medical Writers Association (EMWA)
• La redacción médica como profesión. Coordinadores: Fernando Rico-Villademoros y Vicente Alfaro. Cuadernos de la Fundación Dr. Antonio Esteve Nº 17. 2009. 
• Wikipedia: Medical Writing