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A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…
Dense, hard-to-follow writing obfuscates complex subject matter, but writers can improve their ability to communicate complex topics with clear writing that is easily understood on a first read. Science and medical writing often contain grammatical…
Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,biosimilars and generics require the…
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…
The use of artificial intelligence (AI) writing assistants in the healthcare industry is becoming increasingly prevalent. These tools can help medical writers to generate content more quickly and efficiently, but they also raise concerns about the…
Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…
Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…
Dear all, However experienced you are, and whatever ‘level’ medical writer you may be, we all share the same pain… document review processes. Every medical writer has at least one horror story related to review cycles going awry, and the mere…
On her private Twitter profile, Julie (Juliane) describes herself as “freelance medical editor, mother, immunologist with an interest in tropical diseases and vaccines”. Julie works as a freelance medical writer and editor, is managing editor at…
How does a team of medical writers working in different countries navigate different time zones and cultures to get their work done remotely? In this interview, a team of six medical writers and one editor working at P95, a private research…
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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