Regulatory writing basics - Volume 23, Issue

The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…

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…

Medical Communications and Writing for Patients - Volume 30, Issue

Dear All,

As I write this, at least some of us are likely to still be in some form of lockdown or quarantine. I pray that you and your families are all managing to stay as sane as possible, and I sincerely hope that you all stay safe and healthy.

I…

Moving into medical writing from academia: A soft skills perspective - Volume 33, Issue

As I made the transition into medical writing and started learning the ropes, I realised first-hand that in addition to writing skills, soft skills are indispensable in becoming an effective medical writer. Not only are they vital in helping you…

Medical writing in paediatrics: Children and the future - Volume 21, Issue

‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…

Medical writing in Italy in 2024: Results of the first Italian business and compensation survey - Volume 33, Issue

In Italy, little is known about the roles, activities, and compensation of medical writers and scientific communicators. A survey, tailored to local aspects and regulations, was conducted to capture a contemporary snapshot of the medical writing…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

One size doesn’t fit all: Tailored medical writing mentoring and training - Volume 30, Issue

While there is ultimately no “secret sauce” to mentoring, in this article I outline my nonnegotiables, which, although not rocket science, often take the mentor’s concerted effort to implement. Firstly, everyone is different. While hardly…

Advancing the Medical Writing profession: The Joint Position Statement on the Role of Professional Medical Writers - Volume 26, Issue

A wintry London in January saw the release of the first joint position statement on the role ofthe professional medical writer (page 7). But why do we need such a statement and what does it say? The Executive Committee identified the need to update…

On educating the medical writer - Volume 22, Issue

Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…