MEDICAL WRITING: what is it?

 

MEDICAL WRITING

With the constant advancement and innovation in medicine and health care, the need to communicate about research findings, products, devices, and services is growing. Medical writers are increasingly in demand to convey new information to health care professionals as well as the general public.

Medical writing is a profession dedicated to the communication of medical, scientific and health information, including research reports, consumer (patient) information, and regulatory documents.Medical writing involves creating well-structured scientific documents that include clinical research documents, content for healthcare websites, health magazines, journals and news. Medical writing can be classified into two types: Regulatory medical writing and Educational medical writing.

Regulatory medical writing involves writing documents for regulatory agencies seeking approval for devices, drugs and biologics. This includes clinical trial data, regulatory submission documents, post approval documents, etc.

Educational medical writing is writing documents about devices, biologics and medicine, specifically for general studies.

Skill in a medical writer:

A certain level of skill and knowledge about the subject is enough to be a medical writer; a competent medical writer should have following qualities:

·         Good understanding of scientific, pharmaceutical (Including drug names and composition), and medical terminologies. Many companies require the medical writers to have a bachelor or master degree in medical sciences or one of the following areas: ♦ Life sciences (Microbiology, Biochemistry, Biotechnology, Zoology, Botany, Environmental Biology, Ethiology etc.) ♦ Chemistry ♦ Medicine ♦ Pharmacy ♦ Nutrition and dietetics z

·         An excellent command over English language and grammar

·         Awareness about modern literature survey tools, presentation methods of research data, publishing, reviewing, and editing requirements

·         A good interpretation of target audience needs and along with it a good communication and coordination with various people involved in the process

·         Better understanding and perception of project’s requirements and objectives along with ethical and legal issues

·         A good sense of organizing thoughts and ideas

·         Ability to deliver the projects within a stringent timeline

Audiences for medical writers are as varied as the documents that they write. Following are some different types of medical writing. Writers new to medical writing may be involved in one or two of these types while experienced medical writers are usually well versed with all these different types of writing:

Medical journalism
Documents written under medical journalism are generally for public at large. Such documents generally consist of newspaper and magazine articles and are written in as simple language as possible.

Medical education:
For physicians and other healthcare professionals, medical writers are generally involved in writing textbooks, preparing online study material, powerpoint presentations, Continued Medical Education (CME) programs etc.

For patients, medical writers are routinely involved in developing education material. This generally falls under medico-marketing writing in pharmaceutical companies.

Medical marketing of healthcare products:
Medico-marketing writing comprises of a major chunk of total work that is assigned to medical writers working in pharmaceutical and biotechnology companies. Many medical communication companies also hire medical writers to handle medico-marketing work outsourced to them. Medico-marketing writing involves developing promotional and advertising material, training manuals, product monographs, web content for general public, online learning study material etc.

Publications & presentations:
Writing abstracts, posters and presentations for presenting research results at conferences, seminars and other meetings is very common for medical writers. Medical writers also write and review and edit journal articles and manuscripts.

Research documents:
Medical writers are a very important part of any new drug development team. They play a critical role in developing important research documents such as clinical trial protocols, informed consent forms, investigators brochures, clinical study reports, subject diaries etc.

Regulatory documents:
A strong regulatory writing is team is crucial for any pharmaceutical or biotechnology company. They are generally the same writers involved in medico-marketing writing as well. Regulatory medical writers write documents needed for regulatory submissions such as for marketing approval of new drugs or for approval to conduct new clinical trials. Such documents involve package inserts of drugs, subject narratives, Common Technical Document (CTD), safety update reports, annual reports etc.

All these types of documents written by medical writers have their own set of audience and the language used must be optimized for each group for most effective communication to take place. Documents meant for lay people or general public must be as simple and as free from technical language as possible. Documents for the scientific community must meet their expectations and may contain technical jargon with research data & its explanation. Similarly, documents meant for regulatory agencies must be detailed and as per the formats and guidelines issued by them which medical writers must be aware about.