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The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…

The soft skills gap for remote workers: Different perspectives - Volume 33, Issue

The COVID-19 pandemic has transformed the way we work, with many companies opting for fully remote or hybrid roles on a permanent basis. While remote working has many advantages, there are some soft skills that may deteriorate when working from home…

The Crofter: Sustainable Communications - Volume 32, Issue

Rising to the challenge of sustainability in healthcare communications Climate change is among the greatest global challenges facing humanity, and although progress on tackling the issue is slow, the pharmaceutical industry is taking it seriously.…

Regulatory Matters - Volume 33, Issue

Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…

From the Editor - Volume 32, Issue

Biotechnology – diverse as the colours of the rainbow Ask 10 people what “biotechnology” means and you will get 10 different answers. In this column, the Editor-in-Chief highlights the variety and breadth of the field and notes the important role…

From the Editor - Volume 32, Issue

As pharma companies strive for carbon neutrality, carbon accounting is now part of day-to-day business; the carbon footprint for each process, each step, and each stakeholder is closely scrutinised. Freelance medical writers and communicators as busi…

The balancing act: Leading creative teams for clear, accurate science communication - Volume 33, Issue

Leading a team is inherently complex, requiring managers to juggle diverse organisational goals, meet superiors’ expectations, and cater to individual team member needs. The challenge intensifies when leading creative teams in a scientific environmen…

To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting - Volume 32, Issue

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…

Landscaping the terminology of accessible language document types - Volume 31, Issue

There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain…

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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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