Medical Writer
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A medical writer, also referred to as medical communicator, is a person who applies the principles of
clinical research Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. The ...
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 Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. Major Synopsis The CTD is an internationally agreed ...
. 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 Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...
, medical device industry and
Contract Research Organizations In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provid ...
(CROs) because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new
drug A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. Consumption of drugs can be via insufflation (medicine), inhalation, drug i ...
s go through the increasingly complex process of
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
s and
regulatory Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. Fo ...
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. The medical writing market is estimated to be USD 3.36 billion in 2020 and is growing at a 12.1% compound annual growth rate.


Overview

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 A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
. 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 The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. Major Synopsis The CTD is an internationally agreed ...
TDformat) 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 Health has a variety of definitions, which have been used for different purposes over time. In general, it refers to physical and emotional well-being, especially that associated with normal functioning of the human body, absent of disease, pain ...
. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists,
consumer education Consumer education is the preparation of an individual to be capable of making informed decisions when it comes to purchasing products in a consumer culture. It generally covers various consumer goods and services, prices, what the consumer can ...
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.


Organizations

Several professional organizations represent medical writers around the world. These include: *
American Medical Writers Association The American Medical Writers Association (AMWA) is a professional association for medical communicators, with more than 4,000 members in the United States, Canada, and 30 other countries. AMWA is governed by a board of directors composed of the ele ...
(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 The Council of Science Editors (CSE), formerly the Council of Biology Editors (CBE; 1965–2000) and originally the Conference of Biology Editors (CBE; 1957–1965), is a United States–based nonprofit organization that supports editorial pract ...
compiled in 2003 a list of books that might be helpful in medical and/or science writing. In 1978 the ''
BMJ ''The BMJ'' is a fortnightly peer-reviewed medical journal, published by BMJ Publishing Group Ltd, which in turn is wholly-owned by the British Medical Association (BMA). ''The BMJ'' has editorial freedom from the BMA. It is one of the world' ...
'' editor Stephen Lock recommended Hawkins's 1967 book ''Speaking and writing in medicine'' and 4 other books.


Importance of lucidity


Medical writing in social media

With the invention of the internet, social media has become a main source of information for patients concerned with certain health issues. It differs from other sources through characteristics such as instantaneous and limitless reach and user-generated content. Unfortunately, these aspects can lead to a lack of quality and reliability. User-generated content often leads to content written by unknown authors where the information itself may be incomplete, unreferenced, or informal. Also, unlike
evidence-based medicine Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. It means integrating individual clinical expertise with the best available exte ...
, social media tends to magnify anecdotal reports. However, there are measures available to decrease this issue. Individuals can help reduce health misconceptions online by countering false or misleading claims with clear, evidence-based responses and cited sources. Social media presents communication challenges in health discussions, but these can be addressed by minimizing technical jargon, using plain language, and maintaining a concise, professional tone. Identifying the target audience allows for a more precise and relevant approach. Skilled medical writers understand medical language and culture, enabling them to effectively tailor content for specific readerships.


Medical writing in freelance market

Medical writing is a growing sector in the freelance market, with writers specializing in healthcare-related content. Freelance medical writers offer services such as writing medical articles, research papers, case studies, and regulatory documents. Many hold advanced degrees in medicine,
biology Biology is the scientific study of life and living organisms. It is a broad natural science that encompasses a wide range of fields and unifying principles that explain the structure, function, growth, History of life, origin, evolution, and ...
, or related fields and possess expertise in
medical terminology Medical terminology is a language used to precisely describe the human body including all its components, processes, conditions affecting it, and procedures performed upon it. Medical terminology is used in the field of medicine. Medical terminolo ...
and concepts, enabling them to produce accurate and informative content. One of the advantages of working with freelance medical writers is the ability to review their portfolio and samples of their work. Clients can also read reviews from other clients who have worked with them in the past, which helps them make informed decisions about who to hire and ensures that they receive high-quality work. In addition, freelance medical writers offer a range of pricing options, making it possible to find a writer who fits within your budget. Some medical writers charge by the hour, while others charge by the project. This flexibility allows clients to find a writer who can provide the services they need at a price they can afford.


See also

* '' AMWA Journal'' * Medical ghostwriting *
Scientific writing Scientific writing is about science, with the implication that the writing is done ''by scientists'' and for an audience that primarily includes ''peers''those with sufficient expertise to follow in detail. (The similar term " science writing" in ...
*
World Association of Medical Editors The World Association of Medical Editors (abbreviated WAME, pronounced "whammy") is an international, virtual organization of editors of medical journals. It was originally founded in 1995 by a group of members of the International Committee of Me ...
(WAME)


References


External links

* {{Medical research studies, state=collapsed Medical literature Literature by topic Health research