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Good medical writing saves lives: The perspective of a former medic - Volume 26, Issue

Making the decision to leave medicine was the hardest of my life. What if all those years of study, thousands of pounds of debt and sacrifices I made were not wasted but instead prepared me for my most gallant career yet – medical writing? Believing…

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

Addressing vaccine hesitancy in writing: How has COVID-19 changed hesitancy communication, and what works? - Volume 30, Issue

To address vaccine hesitancy in writing, it is important to put yourself in your reader’s shoes, demonstrate an understanding of the hesitancy, and form an effective response using evidence-based writing techniques, clear communication, courtesy,…

Profile - An Interview with Juliane Chaccour - Writing in Mozambique - Volume 25, Issue

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…

One size doesn’t fit all: Tailored medical writing mentoring and training - Volume 30, Issue

While there is ultimately no “secret sauce” to mentoring, in this article I outline my nonnegotiables, which, although not rocket science, often take the mentor’s concerted effort to implement. Firstly, everyone is different. While hardly…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

A shot at demystifying the risk management plan for medical writers - Volume 24, Issue

A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…

Advancing the Medical Writing profession: The Joint Position Statement on the Role of Professional Medical Writers - Volume 26, Issue

A wintry London in January saw the release of the first joint position statement on the role ofthe professional medical writer (page 7). But why do we need such a statement and what does it say? The Executive Committee identified the need to update…

Charting your way to the top: The 12 major milestones of freelance medical writing - Volume 32, Issue

As a freelance medical writer, it’s tough to know how well you’re doing – conventional career metrics don’t apply and you don’t have a boss keeping tabs on you. Yet, for your medical writing business to stand the test of time, with you at the helm,…

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Scope

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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