Regulatory Medical Writing Basics
Document development process, key regulatory documents, and tips and tools for success
Ratings 4.42 / 5.00
What You Will Learn!
- Understand the role of a regulatory medical writer
- Have developed a medical writing toolkit for success
- Be equipped with a proven process for document development, from kick-off to submission
- Understand how to provide extraordinary value to your teams
- Know what to ask of your clients/teams to ensure successful project execution
- Have a basic understanding of the types of documents that regulatory medical writers develop
- Better understand the content and development process for 3 key documents: protocols, investigator's brochures, and clinical study reports
Description
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.
Who Should Attend!
- This course is intended to help students or early-career professionals potentially interested in a career in regulatory medical writing form a better understanding of what it is regulatory medical writers do and how to succeed in the role. While this course will not guarantee that you land a writing job (if I could create such a course, I 100% would!), it will provide you with some of the basics of what medical writers do, how they can contribute to their teams, and provide you with some of the basic lingo of regulatory medical writers. This course may help you decide if regulatory medical writing is a career for you, and will provide you with confidence to start working in the field!