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

David B Clemow¹, Bertil Wagner², Christopher Marshallsay³, Dan Benau⁴, Darryl L'Heureux⁵, David H Brown⁶, Devjani Ghosh Dasgupta⁷, Eileen Girten⁸, Frank Hubbard⁹, Helle-Mai Gawrylewski¹⁰, Hiroko Ebina¹¹, Janet Stoltenborg¹², J P York¹³, Kim Green¹⁴, Linda Fossati Wood¹⁵, Lisa Toth¹, Michael Mihm¹⁶, Nancy R Katz¹⁷, Nina-Maria Vasconcelos¹⁸, Norihisa Sakiyama¹⁹, Robin Whitsell²⁰, Shobha Gopalakrishnan²¹, Susan Bairnsfather²², Tatyana Wanderer²³, Thomas M Schindler²⁴, Yeshi Mikyas²⁵, Yumiko Aoyama²⁶

Affiliations

¹ 1 Eli Lilly and Company, Indianapolis, IN, USA.
² 2 Janssen R&D LLC, Raritan, NJ, USA.
³ 3 Gruünenthal GmbH, Rheinland, Germany.
⁴ 4 University of the Sciences, Philadelphia, PA, USA.
⁵ 5 Bristol-Myers Squibb, Philadelphia, PA, USA.
⁶ 6 AstraZeneca, Washington, DC, USA.
⁷ 7 Cognizant Technology Solutions, San Francisco, CA, USA.
⁸ 8 inVentive Health Clinical, Philadelphia, PA, USA.
⁹ 9 Global Regulatory Writing Solutions Inc, Philadelphia, PA, USA.
¹⁰ 10 Janssen R&D LLC, Titusville, PA, USA.
¹¹ 11 ProScribe - Envision Pharma Group, Marunouchi, Chiyoda-Ku, Japan.
¹² 12 AstraZeneca, Wilmington, DE, USA.
¹³ 13 Galderma Laboratories LP, Dallas, TX, USA.
¹⁴ 14 Synchrogenix - a Certara Company, Wilmington, DE, USA.
¹⁵ 15 MedWrite, Inc, Westford, MA, USA.
¹⁶ 16 Astellas Pharma Inc, Chicago, IL, USA.
¹⁷ 17 Illyria Consulting Group, Inc, Soda Springs, CA, USA.
¹⁸ 18 Novo Nordisk A/S, Copenhagen, Capital Region, Denmark.
¹⁹ 19 AstraZeneca Japan, Osaka, Japan.
²⁰ 20 Whitsell Innovations, Inc, Raleigh-Durham, NC, USA.
²¹ 21 Freelance Writer, Perry Hall, MD, USA.
²² 22 EPharma Tech LLC, Shreveport, LA, USA.
²³ 23 Synchrogenix - a Certara Company, Nashville, TN, USA.
²⁴ 24 Boehringer Ingelheim, Ingelheim, Germany.
²⁵ 25 MedImmune, Washington, DC, USA.
²⁶ 26 Astellas Pharma Inc, Tokyo, Japan.

PMID: 29714611
DOI: 10.1177/2168479017721585

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

David B Clemow et al. Ther Innov Regul Sci. 2018 Jan.

. 2018 Jan;52(1):70-77.

doi: 10.1177/2168479017721585. Epub 2017 Sep 1.

Authors

Affiliations

¹ 1 Eli Lilly and Company, Indianapolis, IN, USA.
² 2 Janssen R&D LLC, Raritan, NJ, USA.
³ 3 Gruünenthal GmbH, Rheinland, Germany.
⁴ 4 University of the Sciences, Philadelphia, PA, USA.
⁵ 5 Bristol-Myers Squibb, Philadelphia, PA, USA.
⁶ 6 AstraZeneca, Washington, DC, USA.
⁷ 7 Cognizant Technology Solutions, San Francisco, CA, USA.
⁸ 8 inVentive Health Clinical, Philadelphia, PA, USA.
⁹ 9 Global Regulatory Writing Solutions Inc, Philadelphia, PA, USA.
¹⁰ 10 Janssen R&D LLC, Titusville, PA, USA.
¹¹ 11 ProScribe - Envision Pharma Group, Marunouchi, Chiyoda-Ku, Japan.
¹² 12 AstraZeneca, Wilmington, DE, USA.
¹³ 13 Galderma Laboratories LP, Dallas, TX, USA.
¹⁴ 14 Synchrogenix - a Certara Company, Wilmington, DE, USA.
¹⁵ 15 MedWrite, Inc, Westford, MA, USA.
¹⁶ 16 Astellas Pharma Inc, Chicago, IL, USA.
¹⁷ 17 Illyria Consulting Group, Inc, Soda Springs, CA, USA.
¹⁸ 18 Novo Nordisk A/S, Copenhagen, Capital Region, Denmark.
¹⁹ 19 AstraZeneca Japan, Osaka, Japan.
²⁰ 20 Whitsell Innovations, Inc, Raleigh-Durham, NC, USA.
²¹ 21 Freelance Writer, Perry Hall, MD, USA.
²² 22 EPharma Tech LLC, Shreveport, LA, USA.
²³ 23 Synchrogenix - a Certara Company, Nashville, TN, USA.
²⁴ 24 Boehringer Ingelheim, Ingelheim, Germany.
²⁵ 25 MedImmune, Washington, DC, USA.
²⁶ 26 Astellas Pharma Inc, Tokyo, Japan.

PMID: 29714611
DOI: 10.1177/2168479017721585

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.

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

PubMed Disclaimer

MeSH terms

Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
- Atypon
- Springer
Other Literature Sources
- scite Smart Citations

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources