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Regulatory Medical Writing Basics

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Regulatory Medical Writing Basics, available at $19.99, has an average rating of 4.39, with 41 lectures, based on 110 reviews, and has 384 subscribers.

You will learn about 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 This course is ideal for individuals who are 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! It is particularly useful for 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!.

Enroll now: Regulatory Medical Writing Basics

Summary

Title: Regulatory Medical Writing Basics

Price: $19.99

Average Rating: 4.39

Number of Lectures: 41

Number of Published Lectures: 41

Number of Curriculum Items: 41

Number of Published Curriculum Objects: 41

Original Price: $59.99

Quality Status: approved

Status: Live

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

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!

Target Audiences

  • 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!

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.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Welcome

Lecture 2: Breaking Down the Myths

Lecture 3: Course Objectives and Content

Chapter 2: The Role of Regulatory Medical Writers

Lecture 1: The Who, What, Where, When, and Why of Medical Writing

Chapter 3: Tools for Successful Document Development

Lecture 1: Guidances, Templates, and Style Guides

Lecture 2: Walk-Through of ICH E6 Guidance

Lecture 3: The Value of Templates in Medical Writing

Lecture 4: Walk-Through of the Transcelerate Protocol Template (Contents of a Template)

Lecture 5: Style Guides: The Medical Writer's Go-To Resource

Lecture 6: Other Software and Tools for Success

Chapter 4: Document Development Process

Lecture 1: Steps for Developing a Regulatory Document – Part 1

Lecture 2: Steps for Developing a Regulatory Document – Part 2

Lecture 3: Walk-Through of Example Timeline

Chapter 5: Becoming an Effective Medical Writer

Lecture 1: Writing Effective Regulatory Documents

Lecture 2: Working Collaboratively to Develop Documents

Lecture 3: Tips for Moving Documents Through the Development Process

Lecture 4: Challenges in Medical Writing

Lecture 5: How Medical Writers Add Value to Their Teams

Chapter 6: Documentation in Drug Development

Lecture 1: Types of Regulatory Documents and the Common Technical Document (CTD)

Lecture 2: Regulatory Submissions and Applications

Lecture 3: Content of the CTD – Part 1

Lecture 4: Content of the CTD – Part 2

Lecture 5: Content of the CTD – Part 3

Lecture 6: Clinical Trial Documents and Other Regulatory Documentation

Chapter 7: Clinical Trial Protocols

Lecture 1: What is a Clinical Trial Protocol?

Lecture 2: Clinical Trial Design

Lecture 3: Controls and Bias Elimination

Lecture 4: Objectives, Endpoints, Population, and Assessments

Lecture 5: Process for Protocol Development

Lecture 6: Walk-Through of the Transcelerate Protocol Template (Sections of a Protocol)

Lecture 7: Protocol Tips and When to Amend

Chapter 8: Investigator's Brochures

Lecture 1: What is an Investigator's Brochure (IB)?

Lecture 2: Content of an IB – Sections 1 through 5

Lecture 3: Content of an IB – Sections 6 and 7

Lecture 4: IB Tips and When to Update

Chapter 9: Clinical Study Reports

Lecture 1: What is a Clinical Study Report (CSR)?

Lecture 2: Non-Data vs Data Sections of a CSR

Lecture 3: Other Components of a CSR: Safety Narratives, CSR Synopsis, and Appendices

Lecture 4: CSR Tips and Types

Chapter 10: Summary and Wrap-Up

Lecture 1: Daily Life as a Regulatory Medical Writer

Lecture 2: Staying Up to Date as a Medical Writer and Final Tips for Success

Instructors

Rating Distribution

  • 1 stars: 0 votes
  • 2 stars: 0 votes
  • 3 stars: 17 votes
  • 4 stars: 41 votes
  • 5 stars: 52 votes

Frequently Asked Questions


How long do I have access to the course materials?


You can view and review the lecture materials indefinitely, like an on-demand channel.


Can I take my courses with me wherever I go?


Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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