Medical Writing Competency Model - Section 2: Knowledge, Skills, Abilities, and Behaviors

Ther Innov Regul Sci. 2018 Jan;52(1):78-88. doi: 10.1177/2168479017723680. Epub 2017 Aug 30.


This article provides Section 2 of the 2017 Edition 2 Medical Writing Competency Model that describes the knowledge, skills, abilities, and behaviors that professional medical writers need in order to perform effectively within the life sciences industry. What a medical writer should know, what they should be able to do, and how they should use this knowledge and these skills to facilitate their primary work function is a focus. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The full Model also includes Section 1, which covers the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry; Section 1 is included in a companion article. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.

Keywords: competency; medical; publication; regulatory; writing.

MeSH terms

  • Behavior
  • Biological Science Disciplines
  • Guidelines as Topic
  • Humans
  • Medical Writing / standards*
  • Professional Competence