Soft Skills for Medical Writers - Volume 33, Issue

The Investigator's Brochure: A multidisciplinary document - Volume 23, Issue

The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…

The regulatory-HTA decision-making interface: What the medical writer should know - Volume 30, Issue

For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…

Setting up for success: An overview of why mentoring matters for aspiring medical writers - Volume 30, Issue

The most successful people attribute their success to an effective mentoring network. Developing a great mentor network is critical to ensuring long-term professional development and growth. This article presents an overview of the mentoring…

Good medical writing saves lives: The perspective of a former medic - Volume 26, Issue

Making the decision to leave medicine was the hardest of my life. What if all those years of study, thousands of pounds of debt and sacrifices I made were not wasted but instead prepared me for my most gallant career yet – medical writing? Believing…

From bench to pen: Life as a new medical writer - Volume 28, Issue

In search of a career that would take advantage of their graduate-level skills, Clare Chang and Zuo Yen Lee found medical writing – a career path few PhD students consider. Within 6 months of graduating, with lots of effort and some luck, they found…

Medical Writing Humour - Volume 29, Issue

We ended our recent Intensive Medical Writing Course at Copenhagen University with a session on cover letters.

Veterinary Medical Writing - Volume 29, Issue

Cemile Jakupoglu of Cyton AH Biosciences GmbH and Maggie Fisher of Veterinary Research Management give the Veterinary Medical Writing section of the journal an overview of some major changes involved in therevision of the “Guideline on the conduct…

My First Medical Writing - Volume 31, Issue

I am pleased to share an article by an aspiring medical writer from Poland. Hanna KurlandaWitek finished her PhD in geoscience at the University of Edinburgh, specialising in microbiology. After working in an environmental consultancy for a few…