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Regulatory writing for rare disease: An interview with Kelley Hill - Volume 34, Issue

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…

Medical Devices - Volume 33, Issue

Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…

Lingua Franca and Beyond - Volume 30, Issue

Our mentors It is my great pleasure to introduce this article written by Julia Bates from Australia, who in a very personal way describes her journey to becoming a very professional and experienced medical writer – a journey that often went across…

EMWA news - Volume 21, Issue

News from the EMWA Website Manager New role At the recent EMWA conference held in Cyprus, I assumed the position of EMWA Website Manager. While this is a daunting task, it is a challenge I am pleased to take on. To ensure that I was in a…

“Follow the Sun” writing: A hybrid operating model to optimize collaboration and efficiency - Volume 33, Issue

Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…

The Crofter: Sustainable Communications - Volume 32, Issue

EditorialSection Editor: Kimi Uegaki Growing and nurturing a grassroots sustainability team in a clinical centre Authors: Sarah Kabani, Virginie Chasseigne, Sihame Chkair Medical Writing. 2023;32(4):87–89. https://doi.org/10.56012/wynp1520

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…

Quality control: getting the best out of your review - Volume 21, Issue

In medical writing, quality control (QC) means ensuring that a document's content, style, and format are of high quality. This does not just ‘happen’ but is the result of a systemic QC review. These reviews are critical because mistakes can cause…

Jumping over and through the obstacles: Navigating the freelance landscape - Volume 32, Issue

This article explores the major challenges and strategies for succeeding as a freelance medical writer. It covers several topics, including finding enough work, managing heavy workloads, ensuring document quality, and carving out time for…

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…

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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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