Medical Writing Authors and Authorship Project management in medical publication writing: A less explored avenue in pharmaceutical companies and clinical research organisations

Volume 25, Issue 1 - Authors and Authorship

Project management in medical publication writing: A less explored avenue in pharmaceutical companies and clinical research organisations

Abstract

Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing steers the drafting and submission of regulatory dossiers and safety reports to health authorities; medical publication writing on the other hand deals with scientific publications such as manuscripts, abstracts, presentations, and posters. Project management is essential for the expedited execution and seamless delivery of publication writing projects with a quick turnaround time. End-to-end project management of publication writing projects on the lines of five-stage process of the Project Management Body of Knowledge (PMBOK) is discussed in this article.

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References

  1. Wager E. Publishing clinical trial results: The future beckons. PLoS Clin Trials. 2006 Oct 27;1(6):e31.
  2. Pakes GE. Writing manuscripts describing clinical trials: a guide for pharmacotherapeutic researchers. Ann Pharmacother. 2001;35(6):770-9.
  3. Sharma S. How to become a competent medical writer? Perspect Clin Res. 2010;1(1):33-7.
  4. Norris R, Bowman A, Fagan JM, Gallagher ER, Geraci AB, Gertel A, et al. International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23(8):1837-40.
  5. Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461-4.
  6. Van Noorden R. Global scientific output doubles every nine years. 2014 [cited 2015 Nov 27]. Available from: http://blogs.nature.com/news/2014/05/global-scientific-output-doubles-every-nine-years.html
  7. John Hopkins University. Science writing at Hopkins. 2015 [cited 2015 Nov 27]. Available from: http://advanced.jhu.edu/academics/graduate-degree-programs-writing/the-experience/science-writing-at-hopkins/
  8. University of Chicago Graham School. Medical writing and editing. 2015 [cited 2015 Nov 27]. Available from: https://grahamschool.uchicago.edu/noncredit/certificates/medical-writingediting/index
  9. Massachusetts Institute of Technology. MIT graduate program in science writing. 2015 [cited 2015 Nov 27]. Available from: http://sciwrite.mit.edu/
  10. McGuigan GS, Russell RD. The business of academic publishing: a strategic analysis of the academic journal publishing industry and its impact on the future of scholarly publishing. E-JASL. 2008, 9(3). [cited 2015 Nov 27]. Available from: http://southernlibrarianship.icaap.org/content/v09n03/mcguigan_g01.html
  11. Project Management Institute. A Guide to the Project Management Body of Knowledge (PMBOK® Guide). 5th ed. Newtown Square, Pennsylvania USA: Project Management Institute, Inc.; 2013.
  12. Fugh-Berman A, Dodgson SJ. Ethical considerations of publication planning in the pharmaceutical industry. Open Med. 2008;2(4):e121-4.
  13. Sismondo S, Nicholson SH. Publication planning 101. J Pharm Pharm Sci. 2009;12(3):273-9.
  14. Armstrong JS. Peer review for journals: Evidence on quality control, fairness, and innovation. Science and engineering ethics. 1997;3(1):63-84.
  15. Johnson C, Green B. Submitting manuscripts to biomedical journals: common errors and helpful solutions. J Manipulative Physiol Ther. 2009;32(1):1-12.
  16. Atkinson R. Project management: cost, time and quality, two best guesses and a phenomenon, its time to accept other success criteria. Int J Project Man. 1999;17(6):337-42.
  17. De Looze S. Are we nearly there? Resource planning – step by step. The Write Stuff. 2008;17(3):127–32.
  18. Melnic AS, Puiu T. The management of human resources within projects: the structures of the project team, the responsibility assignment matrix. Economy Transdisciplinarity Cognition. 2011;14(1):476-84.
  19. Dubois B. Fostering collaboration. The Write Stuff. 2011;20(4):219-21.
  20. Globerson S. Impact of various workbreakdown structures on project conceptualization. Int J Project Man. 1994;12(3):165–71.
  21. Pololi L, Knight S, Dunn K. Facilitating scholarly writing in academic medicine. J Gen Intern Med. 2004;19(1):64-8.
  22. Williams TM. Using a risk register to integrate risk management in project definition. Int J Project Man. 1994;12(1):17-22.
  23. Motschman TL, Moore SB. Corrective and preventive action. Transfus Sci. 1999;21(2):163-78.
  24. Matthews JR, Matthews RW. Successful scientific writing: a step-bystep guide for the biological and medical sciences. 4th ed. Cambridge, UK: Cambridge University Press; 2014.
  25. El-Sabaa S. The skills and career path of an effective project manager. Int J Project Man. 2001;19(1):1-7.
  26. Team CMMI Product. Capability Maturity Model® Integration (CMMI SM), Version 1.1. CMMI for Systems Engineering, Software Engineering, Integrated Product and Process Development, and Supplier Sourcing (CMMI-SE/SW/IPPD/SS, V1. 1) (2002).
  27. Antony J. Six Sigma in the UK service organizations: results from a pilot survey. Managerial Auditing Journal. 2004;19(8):1006–13.
  28. Herskovitz M. The harmonization of DMAIC and the PMBOK® guide for pharmaceutical lean six sigma projects. 2011 [cited 2015 Nov 27]. Available from: http://www. projectmanagement. com/articles/283581/The- Harmonization-of-DMAIC-and-the- PMBOK–Guide-for-Pharmaceutical- Lean-Six-Sigma-Projects.
  29. Swanson SA. Winning pair: Integrating six sigma and PMBOK guide at an organizational level. 2011 [cited 2015 Nov 27]. Available from: http://www.projectmanagement.com/articles/285914/Winning-Pair–Integrating-Six-Sigma-and-PMBOK-Guide-at-an-Organizational-Level

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Articles

Authors and Authorship
Letter from the Editor
President’s Message
Ghostwriting prevalence among AMWA and EMWA members (2005 to 2014)
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Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation: new themes in the ethical critique of commercial medical literature
Perspective from a leading scientific author: An interview with Professor Ruth Roberts on authors and authoring
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Project management in medical publication writing: A less explored avenue in pharmaceutical companies and clinical research organisations
Never say never! Returning to full-time employment after freelancing
Fifth EMWA freelance business survey
Journal Watch
In the Bookstores
The Webscout
Regulatory Writing: Authorship issues in regulatory documents
English Grammar and Style
Medical Communication
Lingua Franca and Beyond
Gained in Translation
Medical Writing Teaching
Profile: An interview with Phil Leventhal
EMWA’s 2016 Webinar Programme
Out on our own

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