I posed this question on a medical writing affinity group I belong to on Linked In (Professional Medical / Scientific Writers). The shared commentary, all from medical writers, has been quite interesting. In this post I want to share a few of the commentaries and my responses.
It was stated by one commentator: “I do feel, because of the way this question is worded, there is a need to defend my profession.” Another said: “It seems to me that whether or not one describes medical writing as a profession is partly down to semantics, and what any individual person understands by the term profession.” In response, I am not asking you to defend your work, but I am asking you to defend that the work of medical writers as a class is indeed a profession. I shared some thoughts regarding how the scholars characterize the concept of a profession, as I think much more than semantics is involved here.
Another commented “Is medical writing a profession? Well, some parts of it are more professionalized than others, but I think.... as a whole? No, currently it's a job description.” I wholly concur with this position for reasons I have already expressed and additional reasons I will add in this discussion entry. I modified slightly another comment made in the Linked In discussion to help shape a sense of the needed attributes for applying the moniker of professional to medical writing: “That practitioners are expected to understand the complexities of language and communication we've seen in this discussion so far and medical writers use workplace research and academic theory to push the practice of medical writing forward.”
Another interesting comment posed as a question is the following: “On another level, the question is: are you hiring a profession or an individual?” My observations find writing approaches within organizations and across the industry are idiosyncratic and outcomes unpredictable, so therefore the answer is clearly you are hiring individuals. By the way—this variability contributes to why so many enterprises struggle to identify “markers” to use to judge capabilities of medical writing candidates.
This same person said: “which part do we emphasize: the medical or the writer?” The answer I suggest is neither—the emphasis is on reporting first and foremost (and reporting in a manner that is accurate and compliant), then medical insight, and a distant third is writing (in terms of sharing information and shaping knowledge).
Lastly, I want to highlight the following comments: “Currently, I don't know that medical writers are seen as the experts on Medical Writing -- most of the public discourse seems to think we are unreflective cheerleaders for whoever pays our salaries....” and “ We do a lot of the applied science stuff already. But we have not come together to share that as professionals, and I think that's the biggest barrier to professionalism .” Harsh commentaries both, but I suggest each is valid based on my observations of the ways of working in this industry. Unfortunately, I will suggest medical writers who do “applied science stuff” in terms of writing practice and document products are far and few between.
Yes, I want medical writing to be considered a profession. I did not start this post to raise a beef with the notion of medical writing. I opened in the discussion in the hopes of fomenting a thought-filled argument about what it takes to call oneself a professional medical writer. An aspect of professionalism is intelligent practice as defined by scholars like Schon. Intelligent practice is the application of knowledge to the body of work at hand. In this case, documents. I am suggesting that such intelligent practice is not a common attribute within or across communities of medical writing. I say this because of a significant amount of data that suggests the vast majority of documents produced by medical writers fail. These documents fail in terms of purpose, conveyance of logic, and meeting reader’s needs.
In defense of my claim I submit to you that there is considerable data in the public record regarding target-audience usability for the output of medical writing. A survey of keen interest to me shows that FDA reviewers cite poor document quality as a significant impediment to effective, efficient reviews; a comprehension study of clinical study protocols found that over 50% of test subjects (clinical investigators and study sight managers) failed to achieve a passing score in identifying roles and decision making responsibilities in the conduct of a clinical trial. I also suggest that much has been and continues to be written about the poor quality of manuscripts submitted to journals for publications. Additionally, analyses of the writing output in various clinical research genre suggests the documents are written for a persona that has a high command of the English language, enjoys reading long, dense narrative passages, and has an exquisite memory (I am pretty sure this persona does not match the broad audience these document products are intended to serve.)
When I raise these above points with medical writers, which I do all the time, I can say nearly all are unaware of any elements of the work I generalized above. Further, the vast majority of medical writers I encounter are unaware of any aspects of reading theory. Also I suggest to you that few medical writers can distinguish the differences between the concepts of data, versus information, versus knowledge; few of the hundreds of medical writers I have spoken to in the past 10 years have heard of the concept of plain language; most have not heard of the concept of document usability; and even fewer attempt to apply such concepts to their work (why would you when you see your work is to report versus transfer knowledge.) There are certainly individuals and even groups of medical writers who operate in a manner that warrant use of the term professional, but I am unable to find as appropriate, the broad application of the term to the various communities within medical writing.
I am suggesting that the intelligent practice of seeing clinical research documents as tools to be used by others outside of an enterprise is largely absent from the “ways of working” mindset of most medical writers. I am also suggesting that the task of document production—at all levels and for all forms of documentation in the clinical research community—is largely inefficient. Few know what it really costs the organization per page to produce a final version document (many are afraid to know that number); few consider techniques and tools to really transform the document production process (much of what I see done to improve work streams is at best incremental, but is largely “feel good” activity that has no impact whatsoever); few engage in meaningful post work reflection where performance is analyzed consistently across document projects by well-described standards. I could go on, but I think this is enough detail to support my position.
A hallmark of professionals as defined by Donald Schon and others is a continual reflection on practice, both during work and post-mortem and then application of what is learned to transform ways of working and product. If reflection is occurring, then I suggest little fruit is born by the activity for I hear all of the same criticisms of medical writers and clinical documents today as I did in 1994.
Originally published on our Knowledge Management blog
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