Regulatory writing is a specialized field within medical writing that focuses on creating the documentation necessary for regulatory agencies, such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe, to...
Entering the field of clinical and regulatory medical writing can be a thrilling endeavor, filled with opportunities to contribute to groundbreaking research and communicate vital information to diverse audiences. However, for new medical writers, navigating the...
Essential documents are key documents that all clinical and regulatory medical writers new or transitioning into the field should be able to author with little or minimal guidance. These types of documents include clinical study protocols, clinical study reports...
One question I get all the time is “How Can I Get Formal Training in Medical Writing?” This question has come to me most frequently from individuals who are seeking to make a career change but have no writing experience or novice writers who want to enter into...
In an increasingly competitive job market, new medical writers or medical writers wanting to advance their careers can increase their opportunities by maintaining high-quality valuable skills. In today’s article, I would like to discuss the top 3 skills that you can...
Are you ready to immerse yourself in the dynamic world of healthcare communication, clinical documentation, and regulatory writing? Welcome to Medical Writing University,, where we're shaping the next generation of versatile medical communicators. Imagine a learning...
Over the course of my career in medical writing, I’ve worked with two main types of individuals 1) those starting a career in medical writing and 2) those transitioning or advancing their career in medical writing. Both professionals are valuable to the field of...
Have you ever searched “medical writing course” or “how to get into medical writing” or “how to learn more about medical writing” or “how to write a clinical study report?” If so, you are not alone. I find that you have 3 types of people researching the field of...
In the realm of pharmaceuticals and drug development, the New Drug Application (NDA) submission is a pivotal milestone. As an early career medical writer stepping into the world of regulatory writing, understanding the Common Technical Document (CTD) and its modules...
Clinical Study Reports (CSRs) are the linchpin of the drug development process. They provide a detailed account of clinical trials, ensuring transparency and integrity in the presentation of results. This article offers an in-depth exploration of CSRs, shedding light...
In the intricate world of pharmaceuticals, where precision and clarity are paramount, medical writing stands as a cornerstone. It bridges the gap between complex scientific data and its clear communication to diverse stakeholders. This article explores the profound...