Difficulties Assessing the "Value Added" of Professional Communicators Writing in the Life Sciences

As mentioned in previous installments of this discussion, we at McCulley/Cuppan believe that the role of the professional communicator can add considerable value to the research and development process. But we recognize that in order to justify the need (and the added expense) for this expanded role, managers have the daunting task of trying to quantify the value added of such professionals to the organization.

The professional communicator must add value to a company’s information processes and products in order to justify their presence within the pharmaceutical organization. Mead (1998) defines the concept of value quite simply: “Value can be defined as the benefit of an activity minus its cost.” However, to apply that concept of value to the role of a communicator or science writer is not so simple. The value of the communicator in the life science research enterprise is not easy to determine for one principal reason: what value does one place upon a timely, efficient, and effective regulatory submission documents?

The problem is that communication in the life science industries does not lend itself to easy analysis against the traditional measures of professionalism that are routinely applied in other aspects of research or in other writing settings for that matter.

To measure the benefits of the professional communicator’s activity within the life science research organization, and in particular within a research project team, it is necessary to turn to the existing body of research illustrating the ways in which communicators provide project teams with valuable input and experience that enhance the overall quality, timeliness, and labor allocation to the tasks of research and reporting research. Quantitative and qualitative research methods, including case studies and surveys, offer data to demonstrate the significant effect professional communicators have on both organizational processes and products. However, little research and few publications directly address the roles and value of the professional writer within the life science research industries.

It is thus necessary for savvy managers to cast a wide net and look to other fields for relevance to the context of life science research. Managers should consider the task of writing in the work of engineering, aerospace, and computer industries, industries that share an intense document development environment similar to what we see in the life science research environment. These industries are similar to the life sciences in that the document product is used by regulators or buyers to create an informed opinion of the company’s proposed product or service. The caveat we must offer is that there is a thin volume of literature assessing the value added by communicators to these organizations, so the existing body of case studies may not be sufficient. Managers may need to seek out others in their organization or industry that have made use of communicators on their project teams.

Professional communicators can contribute to the understanding of the value added by documenting their work and comparing their tasks and targets with company benchmarks. Communicators must document their tasks over the life of the project because it is not possible to assess value added simply by looking at the documents that writers produce. Jong (1997) points out the problems in the “inspection model of quality control,” a model that when applied to documentation, focuses merely on the cost of writing and occassionaly the cost of review. This model is “inherently vulnerable to error,” as significant costs and errors may be missed. Jong claims, “The best way to improve the quality of the output is to improve the quality of the input” (40). Improving quality of input suggests that researchers carefully consider how they present the logic of their interpretations, how they design information to satisfy readers’ needs, and how they represent the resolution of issues within the framework of their document or sets of documents. Communicators can facilitate this consideration and ensure that the documents are logical, complete, and meet readers’ needs. One way to demonstrate these skills to managers is by comparing “before-and-after” documents that show how the communicator improved the logic and readability of initial drafts or how a communicator involved from the beginning of a project can better convey the resolution of issues than a writer brought in at the end of the project.

The variety of roles for writing in the life science research environment makes it difficult to employ a simple model for calculating the value added of writing specialists where the principal output is an informational product. As Fisher (1998) states, “The profession of technical communication is difficult to define in scope” (186). Within the pharmaceutical and life science research industries, writers and communicators have very different roles in various enterprises. Some are primarily writers, others function principally as editors, some coordinate the compiling of documents for registration filings, some facilitate team-based document development, and some concentrate on knowledge management. The challenge is to understand how professional communicators can contribute to efficiently and effectively producing the desired outcome: a high quality document product that helps in the conveyance of knowledge or the advancement of work on drugs and medical devices. Professional communicators must be able to defend their roles to management. By providing “before-and-after” versions of the documents and recording their tasks and timelines (thus enabling managers to compare those with previous projects), professional communicators may be able to reverse the current trend of having writing as a wholly separate task from research and may be able to start a new trend of utilizing professional communicators.

Works Cited

Fisher, J. “Defining the Role of a Technical Communicator in the Development of Information 

Systems.” IEEE Transactions on Professional Communication 41 (1998): 186-199.

Jong, S. “The Quality Revolution and Technical Communication.” Intercom 44 (1997): 39-41.

Mead, J. “Measuring the Value Added by Technical Documentation: A Review of Research and Practice.” Technical Communication, Third Quarter (1998): 353-379.


Originally published on our Knowledge Management blog

DIA Musings: How Medical Writers View Themselves

I sat in on several sessions during the DIA annual meeting that looked at roles, responsibilities, and skill sets of the medical writer. Not surprised by what I heard as descriptors for the above three points. Rather, I am disappointed by all the things I did not hear mentioned as descriptors. Like all of the items we describe as needed skills in our first post here on this blog: The Role of the Professional Writer in the World of Drug and Medical Device Research. Most striking is the absence of the term "knowledge manager" from any of these discussions. In a nutshell, the prevalent vision of a medical writer is: "the hard skill we engage in is the mechanical task of writing about data and everything else is a secondary soft skill." I suggest this is a rather myopic vision.

If you have read any of the blogs posted here, then you know Philip and I hold a significantly different vision of the requisite skill set, especially the hard skills needed to move down the continuum from data to information to knowledge. This thinking reminds me of how 18th century cottage craftsmen (men and women) viewed their work. They engaged in mechanical tasks to create something, be it a buggy whip, a pot, or a candle. They always thought of themselves in terms of the product they created, not in terms of what the user wanted to do with this product or in terms of the unique skills they used to manipulate simple materials into sophisticated tools. So the buggy whip makers never saw themselves as enablers of faster or more disciplined transportation. The buggy whip makers never saw themselves as practioners of a unique family of skills required to manipulate long plaited strips of leather into semi or very flexible instruments.

(By-the-way, I also find interesting parallels in the place of the work: the 18th century cottage for the craftsman and the 21st century home for many medical writers. More on these parallels some other time.)

Back to the main point here. One presentation was centered on the need to develop a validated writing instrument to test would-be medical writers, so that you can identify the "really good ones" from "all the rest." I am not sure that a writing test will ever come close to doing that. A writing test is only going to identify whether somebody can follow syntactical and lexical rules you hold as important, not whether somebody can consistently structure data so that it becomes meaningful information to the end-user or to assign theoretical or practical significance to information so that is becomes knowledge. Now give me a test that can measure these skills and we'll really have something.

Originally published on our Knowledge Management blog

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

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

Bad Advice on Peer Review of Grant Proposals

The blog Entertaining Research posted some comments on the question I posed regarding formal training for peer review. One piece posted cited work by Alan Jay Smith the Task of the Referee. I think this paper is a good reference point for discussion of peer review of proposed journal articles. However, it is not a good reference regarding the task of assessing grant proposals. I find Smith encouraging some of the elements that contribute to poor review performance and variable outcomes as described by Nancy Mayo, et al. at the 2005 JAMA Conference on Peer Review: “Peering at Peer Review: Harnessing the Collective Wisdom to Arrive at Funding Decisions About Grant Applications” or their associated article: “Peering at peer review revealed high degree of chance associated with funding of grant applications” published in the Journal of Clinical Epidemiology [the conclusion taken by Mayo and her co-authors is there is a lack of concordance among reviewers on the relative merits of individual research grants, which indicates there is a risk that funding outcomes will depend on who is assigned as reviewers rather than the merits of the project] and by Cole, Cole, and Simon: Science, 1981, Vol 214, Issue 4523, 881-886 “Chance and consensus in peer review” [the paper covers an experiment in which 150 proposals submitted to the National Science Foundation were evaluated independently by a new set of reviewers. Results showed little correlation between sets of reviewers and suggest that getting a research grant depends to a significant extent on chance. The implication here is that the method of grant proposal assessment is very idiosyncratic].

In Smith's work, he suggests that subjective assessment of grants is acceptable. That is, judge merit of future work based on prior output even if proposal is sloppy or contains insufficient detail and judge the merit of proposed work based on where one is educated. Here is a quote from his paper:

A major difference between a research proposal and a paper is that a proposal is speculative, so you must evaluate what is likely to result. Therefore, when you evaluate a proposal by a well-known investigator, a substantial fraction of that evaluation should depend on the investigator's reputation. People with a consistent history of good research will probably do good work, no matter how sloppy or brief their proposal. People with a consistent history of low-quality research will probably continue in the same manner, no matter how exciting the proposal, how voluminous their research, or how hot the topic. However, you must also consider the possibility that a well-regarded researcher may propose poor research or that a researcher noted for poor-quality work has decided to do better work. It is important that you do not discriminate against newcomers who have no reputation, either good or bad. In this case, you must rely much more heavily on the text of the proposal and such information as the investigator's PhD institution and dissertation, academic record, host institution, and comments by his or her advisor or others.

The need is for a well-characterized set of standards with associated set of criteria for judging the merits of research proposals. Then all assessors must base their decisions within the framework of the standards and they must make their arguments regarding merit based on the criteria.


Originally published on our Knowledge Management blog

The Role of the Professional Writer in the World of Drug and Medical Device Research

We at McCulley/Cuppan (M/C) begin this new blog discussing a topic that is important to the life sciences industry and yet does not receive enough attention: the role of the professional writer in the world of drug and medical device research. Over time we will touch on several related themes, including Quality, Knowledge Management, and Review Practices. But we'll start by thinking about professional writers.

What is a professional writer? Definitions vary depending on perspective. Those employed as professional writers may have a view of their role that is different from someone who employs them or works alongside them. Our goal here is to provide a meaningful description of the professional writer in the life sciences. We encourage those engaged in such work to pause and consider comparisons between how they approach their work and the descriptions we lay out here and equally to consider how they want others within their respective organizations to view the professional writer in the life sciences. As the starting point for this discussion we want to talk about how professional writers working in the sciences are generally defined, or, to say it more accurately, undefined. In going to Wikipedia we find the definition for a science writer is the following:

A science writer is a journalist who specializes in writing about science topics, and thus practices science journalism. Due to this combination, a science journalist needs to be proficient in two areas: as a journalist who can write well enough for magazines and newspapers, and as a scientist, or at least as a dedicated learner capable of following complex science and explaining it in simple terms.

As a point of comparison the term technical writer has the following definition:

A technical writer is a professional writer who designs, creates, maintains, and updates technical documentation—including online help, user guides, white papers, design specifications, and other documents. Engineers, scientists, and other professionals may also produce technical writing, often handing their work to a professional technical writer for editing and formatting.Technical writers work any technical subject requiring explanation to a particular audience. A technical writer usually is not a subject matter expert (SME). Companies, governments and other institutions hire technical writers not for their expertise in a particular subject, but for their expertise in gathering information, analyzing the subject and the audience, and producing clear documentation. (See technical writing.)The technical writer's primary responsibility is to gather information and produce documentation tailored to a particular audience. A good technical writer creates documentation that is accurate, complete, and as concise as possible. Technical writers communicate in many ways: printed documentation, Web-based or other electronic documentation, training materials, and industrial film scripts.

Searching Wikipedia for the term medical writer finds no definition at all. But the term medical writing yields the following definition:

Medical writing is the activity of writing scientific documentation by someone who is a specialized writer (a medical writer) and is generally not one of the scientists or doctors who performed the research. A medical writer is anyone engaged in communication in the medical or allied professions and sciences. The purpose of medical writing is to have a writing specialist work together with the people who produce the scientific data in order to create documents that effectively and clearly express the messages the data have to tell. The medical writer also serves to make sure that the documents comply with any regulatory, journal or other guidelines in terms of content, format and structure.Medical writing is a well-established function in the pharmaceutical world, due to the fact that people have begun to recognize that not everyone can write a well-structured document that presents information and tells a message clearly and concisely. It is one thing to put a bunch of data onto a page, it is another thing to do it in such a way that someone not familiar with the data can immediately understand the meaning of the data. With an increasing demand for getting new drugs to the market as quickly as possible, writing documents that can be read and understood quickly and easily has become an ever higher priority. Hence, the growth of professional medical writing.

The American Medical Writers Association describes a medical writer in the following manner:

Although successful medical writers come from many backgrounds, we share certain attributes:

• Knowledge of medicine or an aptitude for understanding it
• Ability to write (most medical writing does not require us to write like Hemingway, but medical writers must be able to write clearly at a level appropriate to the audience and the project)
• Education: College degree in science, pharmacy, medicine, journalism, or English. Scientific medical writing generally requires a scientific degree (science, pharmacy, medicine).
• Marketing medical writing generally requires a degree in journalism or English
• Deadline orientation

Characteristics of good medical writer include:

• Thorough research
• Accuracy
• Logical organization
• Clear thinking and writing
• Readability

None of these definitions begins to approach our description of what professional writers do and can do in the task of codifying knowledge into highly usable reports and summary documents. At M/C we see the work of the professional writer in the life sciences as indeed the task of knowledge management.

In 2004, McCulley/Cuppan consultants Stephen A. Bernhardt, Julie Dyke Ford and Gregory P. Cuppan wrote an article for the American Medical Writers Association "From Medical Writer to Communication Specialist: Expanding Roles and Contributions in Pharmaceutical Organizations." (American Medical Writers Association. June 2004.) This article describes our vision of the expanding roles of the medical writer working the pharmaceutical drug development industry. We revisited this article and extended some discussion points to help advance the argument presented in this piece.

Our vision of the definition of the professional writer working in the life sciences is more aligned with the position taken by Sara Smith in her paper Staking a Claim: Positioning Technical Communication in Knowledge Management. Here Smith makes the case that technical writers are knowledge management practitioners (a concept we heartily endorse and apply to medical writers as well). We find it useful to look at how some other technical writers have attempted to define their work. Corey Wick, in his article “Knowledge Management and Leadership Opportunities for Technical Communicators” (2000), suggests that technical writers operate as knowledge managers whereby they extract and synthesize information from people with specialized knowledge and develop it into well-structured and understandable forms that are then usable by others (readers). Amanda Metz Bemer, in her article Technically Its All Communication: Defining the Field of Technical Communication, suggests that knowledge management is a sub-discipline of technical communication (an interesting position that we want to pursue in future postings). She further argues that technical communication should become the area of the organization that “people turn to when they need their knowledge managed.” This vision, as suggested by Metz Bemer, resonates well with us here at M/C and provides a highlight for how we see the professional writer operating in support of research and development projects in the life science industries. In subsequent installments of this discussion we will provide our arguments for the expansion of the role typically held by professional writers in the life sciences and, in the process, we will provide our working definition for that role.

We look forward to the thoughts and ideas of our readers on this topic as well.


Work Cited

Bemer, Amanda Metz. Technically Its All Communication: Defining the Field of Technical Communication. http://orange.eserver.org/issues/6-2/bemer.html/document_view

Smith, Sara. Staking a Claim: Positioning Technical Communication in Knowledge Management. http://orange.eserver.org/issues/6-2/smith.html/document_view

Wick, Corey. Knowledge Management and Leadership Opportunities for Technical Communicators. Technical Communication. 47.4 (2000): 515-29.


Originally published on our Knowledge Management blog