Regulatory Medical Writing Basics

My objective for creating this course is to provide those interested in pursuing a career in regulatory medical writing or those new to the field with a clear understanding of what the role entails, both from a broad perspective and in the day-to-day work. This course provides an overview of the development process for investigational therapies and an introduction to the many types of documents that regulatory medical writers develop. You will learn about some of the key software and tools that medical writers use to be successful. You will become familiar with a standard document development process used in industry, and the importance of each step in that process. You will learn how to confidently navigate the document development process, from kick-off to submission, and how to overcome many of the challenges that often arise. You will learn what goes into major submissions and how different documents within a submission relate to one another. We will walk through a guidance document and template so you understand the importance of these tools. Through this course, I will also share my most coveted tips that I have gathered in my 10+ years as a regulatory medical writer. My goal is that, upon completing this course, you feel confident embarking on a career in regulatory medical writing.