Gained in Translation - Volume 24, Issue

Editorial Welcome to the Translation Section editorial! What we call ‘lay-friendliness’ is a key characteristic of Patient Information Sheets (PIS), which are tightly regulated on a European level to guarantee a comprehensible document that…

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…

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.…

Pharmaceutical medical writing competencies: Comparing self-perception with employers' expectations - Volume 21, Issue

In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Gained in Translation - Volume 25, Issue

Editorial Who is qualified to author a medical translation? This is one of those topics that we often read about on professional translation forums and discussion groups. It is, indeed, a never ending discussion.

Essential modules for teaching publication writers - Volume 22, Issue

Medical writers often help train researchers to compose and publish scholarly articles. Although this represents only a small portion of what medical writers do, it is important for those who train academic researchers to be knowledgeable and…

Opportunities in veterinary writing - Volume 23, Issue

Unlike medical writing, ‘veterinary writing’ does not exist as a defined career path. However, writers are inevitably also required in this field and play important roles in different areas of the veterinary profession for creation of scientific…

Patient-reported outcome measure translation: An overview - Volume 27, Issue

The unique nature of patient-reported outcome (PRO) measures presents unique challenges for translation. Regulators emphasise the importance of maintaining conceptual equivalence across all languages in multilingualand multinational trials, while…

Post-approval regulatory writing - Volume 23, Issue