Document development process, key regulatory documents, and tips and tools for success
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.
What you’ll 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.
Course Content
- Introduction –> 3 lectures • 6min.
- The Role of Regulatory Medical Writers –> 1 lecture • 7min.
- Tools for Successful Document Development –> 6 lectures • 30min.
- Document Development Process –> 3 lectures • 20min.
- Becoming an Effective Medical Writer –> 5 lectures • 26min.
- Documentation in Drug Development –> 6 lectures • 25min.
- Clinical Trial Protocols –> 7 lectures • 39min.
- Investigator’s Brochures –> 4 lectures • 13min.
- Clinical Study Reports –> 4 lectures • 16min.
- Summary and Wrap-Up –> 2 lectures • 6min.
Requirements
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.