Medical writing

Medical writing

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 documents 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 drugs go through the increasingly complex process of clinical trials 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.

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 andbiologics. 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.

Medical writing organizations

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).

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.

Ø  Medical/science writing is increasingly becoming popular among PhD life scientists are having trouble finding traditional laboratory-based, research jobs. The transition from laboratory research to writing is not an onerous one; especially if you like to write.

Ø  As many of you may know, I am a freelance medical/science writer who entered the field about 10 years ago.  Because most freelancers work from home offices, the lack of communication with others can be overwhelming at times. Consequently, many of us subscribe to e-mail-based listservs which allow us to stay in touch with other writers and frreelancers. Most of these medical writing listservs are run and maintained by the American Medical Writers Association (AMWA). In order to access and participate at the listservs, you must be an AMWA member which costs $145 or more per year.

Ø  While the AMWA forums are very popular, AMWA officials assiduously monitors them and at times, restricts some of the content that can be posted. For example, members of the 'freelance business only listserv' are strictly prohibited from posting jobs or alerting others to potential freelance opportunities. AMWA officials contends that these posts are inappropriate and disruptive. However, the real reason for the prohibition may be that AWMA operates a separate, fee-based service that allows freelancers to hawk their services.  In other words, allowing  users to mention freelancing gigs or job opportunities on 'freelance business only' listserv, could potentially jeopardize an additional AMWA revenue stream.

Ø  Occasionally, freelancers like me break the rules (go figure) and mention "hot" jobs or employers who may be looking for writers. I do this because, as a freelancer, I am painfully aware that my success as a freelancer is contingent upon my ability to maintain a regular, ongoing stream of freelance gigs. Unfortunately, the AMWA officers who monitor the listservs (many of whom are not freelancers), don’t understand this. Consequently, repeat offenders-- like me--have been threatened with financial sanctions and possible expulsion from the listserv.

Producing Clear, Acceptable Clinical Study Documentation

WHY THE GROWING EMPHASIS ON MEDICAL WRITING?

With the ever-increasing demand to bring new drugs to market as quickly as possible, the process of writing easily understood clinical study documents is a growing priority for sponsor companies.

Medical writing today is much more than entering data onto a page. Cytel Clinical Research Services specializes in satisfying the growing need for regulatory-acceptable document writing that is familiar with both the emerging clinical design methods and the complexities associated with multi-national, large-scale studies.

PROPER DOCUMENTATION FOR EVEN THE MOST COMPLEX TRIALS

Cytel understands the importance of accurate medical writing as a critical component to the clinical development process. Our clinical planning expertise, meticulous attention to detail and legacy of data quality control ensure your supporting trial documentation is as accurate as it is thorough.

Also, our medical writing clients find especially valuable Cytel's ability to react quickly to urgent information requests, especially regulatory inquiries. Handling such unscheduled demands promptly and accurately is all but routine for Cytel Clinical Research experts.

Typical supporting documents include:

·         Investigator brochures

·         Protocols

·         Clinical Study Reports (CSR's)

·         Regulatory briefing documents

·         Clinical sections of Common Technical Documents (CTDs)

·         Integrated summaries

·         Abstracts for professional meetings

·         Advisory panel meetings - briefing documents, slide sets

·         Posters and presentations

·         Manuscripts


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