Reveal, Rebalance, Release: Thoughts on mentoring young professionals in the industry - Volume 30, Issue

Making the first steps as a medical writer in the pharma and biotech industry can be challenging. Three general principles can help managers foster the growth and development of their team members: Reveal, Rebalance, and Release. Reveal means that…

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…

Managing protocol development with international teams: Soft skill perspectives from a global team of protocol writers - Volume 33, Issue

Clinical trial protocol development forms part of the critical path for launching a trial, which means timelines are tight and progress must be fast and sustained throughout the protocol’s development. In order to be successful, medical writers…

Global and multidisciplinary perspectives on collaboration with medical writers - Volume 33, Issue

Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…

“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…

From algorithms to insights: The role of medical writers in AI-enhanced real-world evidence - Volume 34, Issue

Real-world evidence (RWE) complements randomised controlled trials (RCTs) by assessing treatment effectiveness in diverse populations. Integrating artificial intelligence (AI) and machine learning (ML) enhances RWE by enabling predictive modelling,…

Message from the President - Volume 22, Issue

This is my first message as president of EMWA. I'd like to update all members about the plans and activities of the new EMWA Executive Committee (EC). The spring conference in Manchester was a great success and was the most attended ever. Answers…

Passing the torch - Volume 21, Issue

This issue is the first where I will be serving as Editor-in-Chief of Medical Writing (MEW). Elise Langdon-Neuner, Editor-in-Chief since 2004, will be stepping down. This is yet another step in the evolution of the journal.

For those of you unfamili…

Medical writing education - Volume 22, Issue

Although medical writing as a career has been around for a few decades, medical writing education is relatively new. Many medical writers end up teaching scientific or medical writing, and have built their courses and their teaching style without…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…