Narrative Writing in Healthcare and Drug Safety

Medical writing is a scientific discipline where documents related to medical related works are written by professionals who have a background in life sciences and have skill in writing. Medical writing primarily focuses on providing content for the pharmaceutical industry. It involves writing about different document types like regulatory or research related, disease or drug-related promotional material in print and web form, content for health-related websites, magazines, etc and also for journalism and marketing purposes that relate to the medical sector.

The major divisions of medical writing for the pharmaceutical sector can be classified as the regulatory medical writing and educational medical writing. While regulatory writers focus on creating documents required by the regulatory agencies, educational medical writers produce articles that convey new information about drugs and other biologic to general audiences as well as healthcare professionals.

Medical writers may not be actually involved in the development of a new drug, but they assist the researcher in conveying the research information to targeted audiences. If the audience is the general public or the layman, the article will be a concise summary of the most important facts in simple terms. If the article is meant for medical professionals, then more technical aspects areas included. A good medical writer must have clarity in concepts and be flexible to convey data to audiences in the manner that is required.

Medical writing as a career has become well established and pays well too. Demand for medical writers has increased due to:
– Increased quantity of research by pharmaceutical companies leads to more regulatory paperwork
– Conveying information about new drugs, healthcare professionals and patients require precise and marketable content
– Emergence of the internet and digital media has enabled healthcare companies to promote their products and services online, but this requires good medical writers
– Medical statistical data, increasing in quantity needs medical writers with clarity of thought to simplify and report medical statistics

There are no medical writing courses available as such an experience as a medical writer is gained primarily through working. Sometimes organizations conduct training for their own employees, which is helpful. There exist professional bodies like the American Medical Writers Association (AMWA) which help in providing short term courses and also help in finding potential opportunities. But self-study and self-training is the ideal way to develop into a medical writer with specialized skills.

However, Sollers offers a Drug Safety Literature – Narrative Writing Program for students with a background in healthcare or drug safety. Narrative writing is an integral function of the drug safety industry. Pharmacovigilance is centred on assigning causality to an adverse event through medical review.

Medical writing for regulatory agencies and for scientific communication are the two areas which are currently in demand. Some of the regulatory documents or articles that a regulatory medical writer will write are:

• Package inserts and patient information reports
• Clinical trial study data reports
• Pharmacovigilance documents like annual safety reports
• Periodic adverse drug experience reports (PADER)
• Common Technical Document (CTD)
• Patient safety narratives
• Clinical trial protocols

With respect to scientific communications, the types of documents written are even more diverse such as:

• Educational material for doctors, clinical investigators, and patients
• Conference posters and journal articles
• Health magazine articles and news media reports on health-related information
• Promotional material for sales and marketing of health-related products like pharmaceutical drug

Interested in Sollers’  Healthcare and Drug Safety  ? Get in touch with us at [email protected] or (908) 416-1230.