Policies 0070 and 0043: Juggling different requirements - Volume 27, Issue

Post-approval regulatory writing – How different is it from writing pre-approval documents? - Volume 23, Issue

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…

Biostatistics, data management, and medical writing: A multidisciplinary approach to the development of the CTD integrated summaries - Volume 29, Issue

Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…

From academia to freelance medical writing: Navigating the transition - Volume 32, Issue

Academics who have transitioned to medical communications (MedComms) find that there are many parallels between the two fields, leading to fulfilling and rewarding careers. Many of the skills honed in academia such as research, technical writing,…

Out On Our Own - Volume 24, Issue

None of us like to think of getting older, and retirement may seem like a long way off for many. However, planning for your pension is critical if you want to ensure greater financial freedom without the need to take on so much work later in life.…

Lingua Franca and Beyond - Volume 26, Issue

This issue of Medical Writing is devoted to the improvement of our writing skills. Can you think of a better topic for our section? There is always room for improvement; whatever you do, and whatever you write improving your skills is a challenge,…

Speaking your patients’ language – Is it really worth it? The impact of translation on multilingual patient education materials - Volume 33, Issue

This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help…

Does standardisation improve animal testing of medical devices? - Volume 26, Issue

Abstract Compliance with European regulatory standards in animal research could be viewed as a way of dotting the i’s and crossing the t’s, rather than actually holding the research to scientific scrutiny. Standardisation is important and needs…

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…

My First Medical Writing - Volume 30, Issue

In this release of My First Medical Writing, I have the pleasure to share great articles written by two aspiring medical writers. Nesrine Benhizia-Benaouicha, MD, is a clinical trial manager and academic medical writer at the emergency department in…