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The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…
The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…
Over her 40-year career, Kelley Hill has become regarded as an industry expert in strategic, high-quality, and impactful regulatory writing, especially in the rare disease space. Now enjoying a slower pace of life having retired in 2023, she has led…
In our daily work as coaches and writing trainers, we often work with young scientists who are at the beginning of their careers. When they want to publish their first scientific research paper or when they decide to give their first lecture at an…
In this article, the authors outline the universal right to health, healthcare, and language access in healthcare, with a focus on policies and practices in the European Union and the United States. The authors spotlight contrasting views on whether…
The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…
We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…
The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…
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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