Medical Writing in Clinical ResearchMarch 26, 2011 2011-03-26 17:03
Medical Writing in Clinical Research
Medical Writing in Clinical Research
Many fresher’s who want to make a career in clinical research are often confused about which clinical research domain they should choose for themselves. They frequently come across terms like medical writing, pharmacovigilance, regulatory affairs, business development, quality assurance, etc but being new to this industry they are not able to make out what lies ahead of them and what is exactly meant by these terms and what job profiles they comprise of. In this post, let us talk about Medical Writing and we hope that this will give you aspiring clinical research professionals some idea about what medical writing is all about!
If you look up in Wikipedia, you will get the following definition of 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 does not necessarily have to be a medical person by qualification however some degree of familiarity with medical terms is preferable. A medical writer does not work in isolation, rather works in a team environment. Now, who is team that we are talking about? Doctors, people who conducted the research, statisticians, regulatory professionals and other subject matter experts work hand in hand with medical writers to produce documents that are of highest quality and meet all the applicable regulatory requirements… Medical writers ensure that the documents that they write comply with all regulations and guidelines in terms of content, format and structure.
You may wonder why good medical writers are in demand, especially in the pharmaceutical industry.
The answer to this is simple. Pharmaceutical industry is one of the most highly regulated industries in the world with complex processes ranging from clinical trials to regulatory submissions to marketing of the drug throughout its presence in the market and what not. Good medical writers are in high demand and are considered to be an asset in all companies because there is a need to prepare and write documents which are structured appropriately and which provide clear and precise information. It requires high skill to write complex documents for regulatory submissions and also to write documents that can be easy to understand for the general public which may not be familiar with comprehensive medical terminology.
Normally, medical writing in the pharmaceutical industry can be sub divided into two broad categories:
1. Regulatory Medical Writing and
2. Educational Medical Writing
Regulatory medical writing, as the name suggests, deals in writing documents related to regulatory authorities e.g. FDA, EMEA, DCGI etc. These can include documents related to submission for receiving approval for conducting new clinical trials, submission documents for obtaining approval for marketing a drug, device or biologic etc. Mainly regulatory writing will consist of writing clinical study protocols, clinical study reports, informed consent forms, investigator brochures etc. Writing of these documents has to follow important regulations and guidelines as applicable. These documents in general discuss the data a company gathers in the course of developing a medical product.
Educational medical writing, as the name suggests deals with writing educational content for a particular audience. The audience for example can be health practitioners or the general lay public. Educational medical writing in general consists of writing literature about newly launched products, making presentations for various conferences and meetings etc.
Most large companies usually have in-house medical writers to do this job; however may companies prefer to outsource this work to skilled medical writers. This provides great opportunity to medical writers to work as freelancers for multiple companies at the same time.
If you have a flair and interest towards writing you can consider medical writing as a great career option. James Lind Institute offers an Advanced Diploma in Clinical Research and Medical Writing as well as a Professional Diploma in Medical Writing to help you acquire the skills required to become a good medical writer.