22 April 2008

The Expanded Roles of Professional Communicators in Other R&D-Intensive Organizations

In continuing our discussion on the role of professional communicators we will examine the changing roles of communicators in other research and development organizations to see what can be learned by those writing in the life science R&D arena.
In the aerospace proposal industry, for example, “best-in-class” billion dollar organizations rely heavily on seasoned writing professionals operating as communication specialists to direct the development of their high-stakes multi-million dollar proposal documentation.
New roles for communicators are also seen in the computer industry where document specialists work within cross-functional team structures. For example, document developers have increasingly assumed full and early membership on project development teams, so they contribute their expertise on an on-going basis as hardware, software, and networking products are developed (Kirsch 1989, Zimmerman 1989). Professional communicators play a role in making subject experts’ tacit knowledge into elements that are explicit, which then enables these knowledge elements to be codified into purpose-filled products like research reports and regulatory submission documents (Hughes 2002). This is in contrast to an older organization of work where the development science was completed and the product (hardware or software) along with the development knowledge was "tossed over the wall" to a waiting publications group who would develop the documentation for the existing product. The “toss over the wall” approach can force a publications group to work around flaws in the product, trying to hide poor design conceptualization and execution within the documentation. When the scientific development is assumed completed, and the writing takes over as a wholly separate task, there is no way to back-up the science when flaws are discovered in late-stage development.
The “toss over the wall” approach is still used in many pharmaceutical and medical device research organizations. The separation of research from writing, as suggested by Maura Taaffe in her paper “Issues in Medical Writing”, is, in fact, what we often see in our work with pharmaceutical and device companies. Such separation constrains those doing the writing from getting the full scientific perspective they need early in the document development process to enable them to write the strongest possible documents. Handing off the document development tasks at the end of the process puts documentation on the critical path and can cause difficulty if scientific issues are discovered at late stages by those doing the writing. Delayed document development, which in turn may delay initiation of additional research or submission for regulatory approval, is a major concern across the pharmaceutical and device industries. It is interesting to note Taaffe’s supposition that the clinical community suspects “that good writing is trying to cover up flawed thinking and can lead readers down the path of unreliable, unscientifically valid conclusions.” It is possible that such an attitude contributes to the compartmentalization of knowledge and the application of knowledge.
In response to these recognized problems of workflow organization, the computer industry, the aerospace proposal development industry, and, to some extent, engineering in general have been moving toward a cross-functional team model, with the professional communicator joining the project team early and developing the documentation simultaneously or in advance of the product development science. Writers on these teams contribute user-centered design perspective—they are the team members who tend to be most in tune with the needs of the end user and who understand the difficulties of creating truly helpful documentation. Since they are professional communicators, they also tend to play process roles in group facilitation. In many of the better organizations, they help prototype early document drafts, help manage document reviews, and coordinate various levels of edit over the final study reports, technical manuals, product monographs, and help systems. They also play a role in implementing principles of change and innovation. Thus, the “activity” of a professional communicator comprises many tasks and requires developed skills in several different areas.
Regardless of the industry in which they are employed, professional communicators often do considerably more than just write. In some R&D organizations where we have worked, the writers experience increased responsibilities and are integrally involved with projects and project teams. It is our position that any research enterprise that wants to get the most value from their investment in research should revisit how they are utilizing professional writers in the process of creating their business critical research reports and regulatory submission documents. In the next installment we will discuss ways to quantify the value added by integrating the professional communicator into a project team.

Works Referred and Cited

Hughes, Michael. 2002 “Moving from Information Transfer to Knowledge Creation: A New Value Proposition for Technical Communicators.” Technical Communication 49, No. 3:275-285
Kirsch, J. "Trends in the Emerging Profession of Technical Communication: New." In Barrett, E. (Ed.) The Society of Text: Hypertext, Hypermedia, and the Social Construction of Information. MIT Press, 1989. 209-234

Taaffe, Maura 1998 “Issues in Medical Writing.” Michigan Tech University
http://www.hu.mtu.edu/hu_dept/humanities/tc@mtu/papers/medical.htm

Zimmerman, M. "Reconstruction of a Profession: New Roles for Writers in the Computer Industry." In Barrett, E. (Ed.) The Society of Text: Hypertext, Hypermedia, and the Social Construction of Information. MIT Press, 1989. 235-249.


Originally published on our Knowledge Management blog

05 April 2008

The Value of Broadening the Role of the Professional Writer in Life Science Research Organizations

In the previous installment of this discussion we considered how professional writers may be defined in different disciplines. We argue that the typical role of the medical writer needs to be expanded beyond that of writer and into that of a communicator and knowledge manager. We suggest that having dedicated professional communicators involved in the process of crafting research reports and regulatory filing documents can make a significant value-added contribution to the research process, the representation of science in documents, and the successful registration of medical products.

The stimulus for this discussion is our recognition that employing dedicated medical writers inside pharmaceutical and life science research enterprises is a dwindling practice. It is now quite common for some or all of the writing needs of an organization to be outsourced to third-party vendors. This outsourcing is done to limit labor costs and because the task of writing is not seen as a value-added component of the research process. The issue in most R&D organizations is that the role of the medical writer is undervalued.

In pharmaceutical and medical device companies, the prevalent view is that the task of documenting research is distinctly separate from the task of scientific research. The document is seen at best as informational support and at worst as merely a repository for data and, in both instances, not an integral component of the research process (it is only seen as a necessary component of the regulatory process.) Often research reports are treated merely as data warehouses.

The socialization of the life science research professional through academics and fellowships, coupled with the highly competitive nature of research, has contributed to the environment where the strong inclination is to put the task of creation of research data first and communication of those facts a very distant second. The problem is pervasive and deep-seated. This view encourages researchers to operate under the paradigm that research documents have little value. It remains a minority that will characterize research report writing as a task involving the construction of a critical argument—an argument intended to establish the validity and reliability of presented evidence and postulations of meaning. The adage: “data speak for themselves,” as espoused by the logical positivist philosophy prevalent in the science community of the early 20th century, still has an army of proponents in the world of life science research. To such people, the thought that one has to work to create a study report that communicates well most often means that you are attempting to misrepresent the results. Also this crowd willl consider medical writers as only capable of presenting watered-down versions of the facts.

Reality shows with ample evidence that successful research reports are predicated on more than just good study designs (though this does make the task of writing easier) and someone sitting at the computer who has great attention to detail, reasonable keyboard skills, and good command of the English language. Successful research reports in the realm of drug or medical device companies require close, carefully orchestrated and well-articulated collaboration across a range of technical and scientific disciplines.


Originally published on our Knowledge Management blog