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A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

Soft skills needed for freelance medical writers - Volume 32, Issue

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…

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,…

Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry - Volume 32, Issue

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…

Regulatory Matters - Volume 32, Issue

Section Editors: Zuo Yen Lee, Clare Chang I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document Author: Tiago Silva Medical writing is not easy, especially for new writers still learning the ropes.…

Out on Our Own - Volume 30, Issue

Editorial Welcome readers, I’ve lost count how many times people ask me, what is a medical writer? And it isn’t just my mum and aunt who ask me such a question; medical doctors, PhD students, and academic professors are often surprised that…

In this issue… The Medical Writing Business - Volume 24, Issue

As medical writers, we strive not just to survive but to thrive. Threats, opportunities, and complications come from many directions, and how to best position ourselves, our departments, and our companies requires much thought. Money is important…

Message from the President - Volume 23, Issue

These two years in the Executive Committee flew by. They will remain in my heart for ever. It is difficult to summarise the emotions and the things we accomplished these last two years. When this adventure started in Cyprus, Susan Bhatti, the…

President's Message - Volume 24, Issue

I can't believe that my two years on the Executive Committee are now complete – what a journey from Manchester and Barcelona in 2013, Budapest and Florence in 2014, and finally Dublin in 2015. Apart from travelling many miles, I have had a great…

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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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