Medical writing
Encyclopedia
Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research.
A medical writer, working with doctors, scientists, and other subject matter experts, creates document
s that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the 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 world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drug
s go through the increasingly complex process of clinical trial
s and regulatory
procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.
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, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).
Regardless of the type of medical writing, companies either assign it to an in-house writer, or "outsource" it to an external medical writer or medical writing service.
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.
Finally, though not a medical writing organization, the Drug Information Association
(DIA) provides many resources, including training and career opportunities (via their job board) for medical writers. Also, the University of the Sciences in Philadelphia offers a master's degree in biomedical writing.
A medical writer, working with doctors, scientists, and other subject matter experts, creates document
Document
The term document has multiple meanings in ordinary language and in scholarship. WordNet 3.1. lists four meanings :* document, written document, papers...
s that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the 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 world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
s go through the increasingly complex process of clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s and regulatory
Regulatory compliance
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that corporations or public agencies aspire to in their efforts to ensure that personnel are aware of and take steps to comply with relevant laws and...
procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.
Types of medical writing
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
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
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
Common Technical Document
The Common Technical Document is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency , the Food and Drug Administration and the Ministry of Health,...
[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
Health care provider
A health care provider is an individual or an institution that provides preventive, curative, promotional or rehabilitative health care services in a systematic way to individuals, families or communities....
. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).
Regardless of the type of medical writing, companies either assign it to an in-house writer, or "outsource" it to an external medical writer or medical writing service.
Medical writing organizations
Several professional organizations represent medical writers around the world. These include:- American Medical Writers AssociationAmerican Medical Writers AssociationThe American Medical Writers Association is the world's leading professional association for medical communicators. AMWA has more than 5,600 members in the United States, Canada, and 26 other countries. AMWA is governed by a board of directors composed of a 14-member executive committee and...
(AMWA) - Australasian Medical Writers Association (AMWA)
- European Medical Writers AssociationEuropean Medical Writers AssociationThe European Medical Writers Association was founded in 1989 as a professional organisation for European medical writers, whether working freelance or in-house at pharmaceutical companies or medical communications companies...
(EMWA) - Indian Medical Writers Association (IMWA).
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.
Finally, though not a medical writing organization, the Drug Information Association
Drug Information Association
The Drug Information Association is a nonprofit, worldwide association that aims to foster innovation, improve public health globally and provide a forum for knowledge exchange...
(DIA) provides many resources, including training and career opportunities (via their job board) for medical writers. Also, the University of the Sciences in Philadelphia offers a master's degree in biomedical writing.