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