Intro to Medical Writing

  • Duration: 6 weeks
  • Commitment: 9-12 hours per week
  • Price: US $1,450
  • Class mode: On-Demand, Instructor-led
  • Certificate of Achievement: Evidence of your learning with a Certificate of Achievement from Medical Writing University on successful completion.
  • Start: Open Enrollment Coming Soon

Course Overview

Participants will explore the field of medical writing with a focus on clinical and regulatory medical writing. This medical writing course concentrates on the competencies and practices in the field of clinical and regulatory medical writing related to authoring clinical trial and regulatory affairs related documents in the pharmaceutical industry. We will broadly cover the clinical drug development process including pertinent medical writing deliverables such as clinical study reports, protocols, narratives, briefing documents, and CTD modules for Investigational New Drug (IND) Applications/New Drug Applications (NDAs)/Biologics License Applications (BLAs).

This course is an introductory medical writing course that will cover the technical aspects of good writing practices, standards of clinical and regulatory medical writing, data integrity and interpretation, as well as nontechnical skills related to medical writing.

Relevant medical writing course projects will be drawn from a range of applications to give context to conceptual information and participants will be encouraged to apply their learning to their own work through discussions and medical writing project work.

What Will I Learn?

  • To understand the role of the clinical and regulatory medical writer
  • To examine good medical writing and standard practices in the field of medical writing
  • To familiarize new medical writers with ethics and legal issues
  • To understand the importance of clinical trial data

Who Is This Course For?

This course is suitable for:

  • Professionals who are new to the field of medical writing or who would like to enter into the field of medical writing
  • Individuals who are transitioning into the field of medical writing from a closely related field (i.e., regulatory affairs, scientist, pharmacist, or clinician)
  • Individuals who hold an advanced degree (PhD, PharmD, MD, DVM, or RNs). *PhD postdocs are encouraged to apply