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We often tend to consider the different branches of medical translation as unique islands of knowledge. We may imagine translators specialising in single areas such as oncology, ophthalmology, gynaecology, and so on. Nevertheless, there are indeed…
Have you been commissioned to write a review? Reviews are useful for drawing attention to issues and benefits related to a product. One thing they are not, however, is something to be feared, if you are organised and have a clear idea from the…
Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…
Clinical trial protocols must provide a clear trial design to meet the study objectives. Medical writers must understand and be ready to review and discuss aspects of the trial design with the protocol development team, in order to write a clear and…
In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…
Collecting and using metrics may not be at the forefront of all medical writers’ minds, but they can be an important asset to writers and managers, from freelancers to those working within companies, large or small. Keeping a record of pertinent…
The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…
The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…
Every professional needs to develop a set of hard skills and soft skills to grow and prosper in a designated field, and freelance medical writers are no exception. However, freelancing requires a unique combination of skills, given the independence…
The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers predominantly working in industry or for agencies to learn of their personal and professional…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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