Medical writers create documents, presentations, marketing materials, regulatory applications, and research papers covering the latest medical breakthroughs, treatments, and medicines on behalf of clinical clients. That’s the job description in a nutshell, but what does it demand from the people who do it? We invited Duncan J. Currie BSc, PhD, a senior medical writer with 25 years of experience, to answer a few basic questions with the hope of providing some more insight into the profession.
What is regulatory medical writing as a discipline, and what documents are produced?
Duncan J. Currie: Regulatory medical writing is a science and an art which aims to manage the knowledge and messages that emerge from clinical and scientific data. It creates documents relating to pharmaceutical development for clinical trial personnel, investigators, pharmaceutical companies, and regulatory authorities.
Most regulatory medical writing documents are either related to performing a single clinical study (protocol, clinical study reports, safety narratives, investigator’s brochure, and informed consent forms) or related to clinical programs comprising multiple studies (clinical summary or overview, investigational medicinal product dossiers, and formal responses to regulatory authority queries). Other regulatory medical writing documents might include periodic benefit-risk evaluations, development safety updates, and clinical or risk management plans.
What is the demand for regulatory medical writing and what qualities are required?
DJC: There continues to be a high and rising demand for the skills associated with regulatory medical writing, with global pharmaceutical research and development spending showing no signs of diminishing. This is partly fuelled by increasingly stringent regulatory requirements placed on the pharmaceutical industry and the increased focus on transparency in clinical research. This demand has fostered the recognition of regulatory medical writing as an important and distinct function bolstered by the emergence of dedicated medical writing groups within organisations and supporting professional bodies.
A successful regulatory medical writer will enjoy writing, be a good listener, and be well organised. Proficiency in English is vital because it is the language of the international regulatory landscape. Knowledge of the drug development process and regulatory requirements is important, as is an understanding of guidelines and templates together with computer competency, specifically in using MS Word. A good writer will understand complex science and medical terminology, use appropriate data presentation, recognise good science, bad science, and bias, and respect ethical principles. It is often assumed to be a wholly solitary activity, but the best regulatory medical writing emerges from productive team environments.
What are the typical problems and pressures encountered by a regulatory medical writer?
DJC: There are many challenges a regulatory medical writer may face. Review is an essential part of producing a quality document but can produce writing challenges such as steering a careful path between competing reviewers’ requests. Reviewers may not recognise the constraints writers work under or the template or style restrictions they must abide by. Because it is the final step in what can be a long study-reporting process, writing activities can be squeezed up against immovable deadlines.
Medical writers depend on receiving good information from the team on what are the key messages to be drawn from a piece of clinical research, but this is not always easy to find. Most disciplines in drug development are perceived as repositories of special knowledge on which others would fear to tread. However, because everyone claims some writing skill there is no such holding back when it comes to regulatory medical writing. This can cause writers difficulties and foster an unfair perception that medical writing is fairly low skilled rather than a highly skilled discipline vital to successful pharmaceutical development. After all, once all the effort of completing a clinical trial or clinical programme is over, all that remains is the regulatory medical writer’s report.
About the Author:
Duncan J. Currie BSc, PhD is a member of the European Medical Writers Association as well as the owner and Director of Maze House Medical Ltd. Before going freelance in 2011, Duncan had 16 years of experience as a Senior Medical Writer for international pharmaceutical companies (Pfizer and H. Lundbeck) and clinical research organizations (PPD, Quanticate, and PRA). Prior to that, he earned a BSc in Pharmacology at Liverpool University, a PhD in Clinical Pharmacology at Dundee University, and conducted postdoctoral research at the University of Surrey.
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