|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/regulatory-medical-writing-basics/
课程评论：没有评论
Regulatory Medical Writing Basics 本课程旨在帮助有志于从事监管医学写作职业或新入行者，清晰了解该职位的广泛职责及日常工作。课程将概述研究性疗法的开发过程，并介绍监管医学作家所撰写的各种文件类型。你将学习到医学作家为取得成功所使用的关键软件和工具。你将熟悉行业标准的文件开发流程，并了解该流程中每个步骤的重要性。你将学会如何自信地应对从启动到提交的整个文件开发过程，以及如何克服过程中常出现的挑战。你将了解主要申报文件的构成，以及申报文件中不同文件之间的相互关系。我们将通过解读一份指导文件和模板，让你理解这些工具的重要性。在课程中，我还会分享我作为一名监管医学作家十余年积累的宝贵经验和技巧。我的目标是让你在完成本课程后，能够自信地开启监管医学写作职业生涯。
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.
