Introductory Medical Writing

This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.

Regulatory writing is a skill that must be honed and refined as one gains regulatory knowledge and experience. Regulatory professionals prepare highly detailed documents that are pivotal to the approval and marketing of healthcare products around the world. For those with an aptitude for clear and accurate communication of scientific data, with an eye toward long-term product development strategies, this profession can lead to a rewarding and varied career.

During this course, you will obtain an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field. You will gain a set of resources and a better understanding of the expectations and tasks that will be required of you to be a successful regulatory medical writer.

At a Glance

Target Audience: Regulatory professionals who are new to or have limited experience in regulatory writing, and experienced individuals interested in further developing their skills.

Learning Level: Basic

Total Length of Course: 3 Hours

RAC Points: 3

Medical Device Certificate Elective

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Describe the role of the regulatory professional in medical writing

Identify basic strategies for crafting an effective message

Outline appropriate guidelines and policies for the regulatory writer

Explain basic statistical methods frequently encountered in regulatory writing

Identify strategies for improving document quality