Medical writing

Medical writing is a term originating in the pharma world. It refers to the activity of producing scientific documentation related to medicines by specialized writers. Medical writing involves describing research results, product use and medical information for regulatory authorities or for medical journals. It is a highly specialized field of writing as it involves adherence to clinical trial regulatory procedures. If you are a science graduate and have a good command of English, you can become a medical writer.

Overview

Medical writing as a function became established in the pharmaceutical industry because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely. All new drugs go through the increasingly complex process of clinical trials and regulatory 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.

Types of Medical Writing

Medical writing can be classified into two types - regulatory medical writing and educational medical writing.

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., Common Technical Documents (CTD) that summarize all the studies performed on a drug).

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, consumer education and programs and enduring materials for continuing education (CE) programs.

Skills Required

Medical writers need solid writing skills, attention to factual detail and accuracy, and the ability to see relationships between ideas and organize complex information. They also need to understand the medical concepts and terminology, presentation of data and its interpretation.

See Also

• Clinical trials
• Common Technical Document
• Pharmaceutical industry
• Regulatory affairs

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