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Project management in medical publication writing: A less explored avenue in pharmaceutical companies and clinical research organisations - Volume 25, Issue

Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…

Medical writing at the management level - Volume 28, Issue

Discussion with writers from all walks of life and from across the globe has revealed that we have all come to our chosen career through different pathways. Furthermore, writer jobs are highly variable; two medical writers may have completely…

Medical writing for generics throughout the life cycle - Volume 28, Issue

Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…

Five questions for Ruggero Galici on nonclinical medical writing - Volume 32, Issue

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…

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…

Document management systems for medical writing - Volume 28, Issue

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations - Volume 25, Issue

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…

In this issue of Medical Writing - Volume 23, Issue

Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…

Collecting metrics in medical writing – the benefits to you and your business - Volume 28, Issue

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…

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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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