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

Abstract

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.

Chapter 1: What Are We Really Teaching? Revisiting Technical and Professional Communication�s Pedagogical Training

“…Stormer suggests that the functions of memory and forgetting (mnesis) are inextricably linked in many rhetorical activities because an understanding of the prior state is essential to the value of the current reality. On a pragmatic level, regulatory dossiers and guidelines are intended to be updated as new information comes to light, which makes regulatory documentation necessarily recursive (see Benau 2020;Clemow et al, 2018;DeTora 2020b;Wood & Foote, 2009). In biomedical discourses, Stormer's rendering of rhetorical recursivity and its connection to mnesis provides a model for replacing outdated or incorrect information with new, more reliable data or for medical inquiry that seeks to limit undesirable signs and symptoms.…”

Chapter 6: Technical Communication Reimagined Through a Socio-Technical Problem-Solving Lens

“…Similarly, even in noting a move away from a mechanistic model of medical regulatory writing, Rita Tomlin (2008) signals a need for added scientific knowledge to manage increasingly complex content rather than skills in persuasion or argument. The demand for scientific expertise obviates discussions about whether this knowledge carries intellectual value, even as it elides argument (Benau, 2020;Clemow et al, 2018;DeTora, 2020b, Hamilton, 2014Winchester, 2017 The rhetorical articulation of regulatory documentation is further complicated by requirements for conciseness. ICH guidelines for all documents state that information should not be repeated between text, tables, and figures: text should provide a high-level characterization of data, highlight noteworthy observations, or present a concise discussion and analysis (Hamilton, 2014;ICH E3, 1995;ICM M4 (R2), 2016).…”

Introduction: Promoting a Sustainable Collective Identity for Technical and Professional Communication

“…Biomedical research generates all the scientific information needed to evaluate a medicinal product, and regulatory documentation extends to into various intellectual domains, including chemistry, cell culture and other laboratory research studies, clinical studies, and statistical meta-analyses (Benau, 2020;DeTora, 2020b;Wood & Foote, 2009). Scientific subject matter experts in these fields often have only a passing familiarity with regulatory documentation or publication requirements, which creates a need for experts to educate authors and reviewers (see Battisti et al, 2015;Clemow et al, 2018;Cuppan & Bernhardt, 2012;Hamilton, 2014;Winchester, 2017). Regulatory and medical writers are called on to fill this need, and the intellectual demands of their work has continually increased over time (see Benau, 2020;Clemow et al, 2018;Gillow, 2015;Hamilton, 2014;Winchester, 2017).…”