Medical Writing Competency Model — Section 1: Functions, Tasks, and Activities

Abstract

This article provides Section 1 of the 2017 Edition 2 Medical Writing Competency Model that describes the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry. The functions in the Model are scientific communication strategy; document preparation, development, and finalization; document project management; document template, standard, format, and style development and maintenance; outsourcing, alliance partner, and client management; knowledge, skill, ability, and behavior development and sharing; and process improvement. The full Model also includes Section 2, which covers the knowledge, skills, abilities, and behaviors needed for medical writers to be effective in their roles; Section 2 is presented in a companion article. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. 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.

Optimizing the Value of Regulatory Medical Writers

“…on how to assure quality and consistency in the medical writing function. 1,2 It also serves as a tool to describe the value and contributions of medical writers to drug development and medical communications. The model defines the essential knowledge, skills, abilities, and behaviors (KSABs) necessary for medical writing competency.…”

“…It is purposefully designed to include the scope and breadth of the medical writing profession, and it is applicable to both medical writers and managers of medical writers. 1 The Competency Model establishes 5 core competency domains through which the KSABs applicable to medical writing can be assessed and a medical writer's competency can thus be certified. 1,3 These 5 core competency domains are gathering, evaluating, organizing, interpreting, and presenting.…”

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

“…Section 1 of the Model includes the core work functions, tasks, and activities associated with medical writing and is presented in a companion article. 1 The Model was developed to aid medical writers and managers within the life sciences industry in regard to hiring, training, setting expectations and goals, performance evaluation, career development, and retention. 2,3 Presently, the Model does not differentiate the competencies of novice from experienced writers or role levels.…”

“…Section 1 of the Model includes the core work functions, tasks, and activities associated with medical writing and is presented in a companion article. 1…”

“…The Model is organized into 3 sections. The first section, published separately, 1 is the core of the Model and describes medical writing work by work functions, tasks, and activities.…”