Thoughts on the Knowledge-managing Medical Writer

I have written from time to time here and elsewhere regarding my vision for what should constitute a good working definition of the regulatory medical writing profession in the 2000s. I thought I’d end the year by sharing a few more attributes that make up my working definition. I also want to contrast this vision with my observations of what I see as the most common mind-set for the medical writing profession. I place these considerations before you to see whether they resonate or perhaps play but a very flat note. Comments and counterarguments are always appreciated.

I argue that to succeed in 2013 and the years forward, a regulatory medical writer must see their role as a knowledge manager, not as a writer—that is, not as a scribe of clinical narratives or descriptive text in various types of documents. To play off the work of Metz Bemer in her article Technically It’s All Communication: Defining the Field of Technical Communication I too suggest that many aspects of knowledge management are indeed a sub-discipline of regulatory medical writing. So in this piece I will continually refer to the “knowledge-managing medical writer.”

My observations during the past 10-12 years of many medical writers in many organizations suggest few see or operate in a role beyond “a scribe of clinical narratives or descriptive text in various types of documents.” They do not act in the manner I assign to the knowledge-managing medical writer. This older vision of a medical writer worked in the past and may work in certain situations and with certain document genre today, but will fall to the edges of the road as we move forward in time.

Over the years I have become acquainted with some individuals who really do recognize the importance of knowledge management and representing greater value than “just a scribe.” I do not use this term “scribe” derisively, but in the context of how many clinical development or regulatory submission teams and organizations treat medical writing resources—they are just an afterthought brought in late in the development or strategy life cycles to attend to the matters of writing up the details. Writers may be wrongly characterized to such a model, but then again many are correctly cast. I see the situation as similar to what played out in the Irish monasteries of the 10th century—monastic scribes working in the background arduously producing manuscripts.

I argue that as part of knowledge management, regulatory medical writers at a minimum have a role in advising teams on the effective design of documents for the highly selective professional reader at regulatory agencies. I know there are some reading this piece who fully understand the implications of what reading research shows—and shows with ample evidence I might add—that successful research reports and submission dossiers are predicated on more than just good study results and an adequate template (though this does make the task of writing significantly easier.) A brief digression here: I do not consider whether a submission package is or is not approved as the only parameter of success, but I am not going to describe my working definition of “successful documents” in this piece.

Okay, back to the point—most reading this piece will likely agree that successful documents routinely require more than just someone sitting at the computer who has an advanced degree in the life sciences, great attention to detail, good analytical skills, above average MS Word skills, and good command of the English language prevalent in medical writing (by-the-way: I suggest these attributes make for a reasonable working definition of a scribe.) My observations suggest that not many writers take on the role of advising their teams on effective document design. A role that I fully associate with the knowledge-managing medical writer.

I suggest “successful” clinical research reports require close, carefully orchestrated and well-articulated design intentions and regulatory submission documents demand significantly more consideration of such intentions within and across the “corpus” of various Module 2 submission documents. Therefore, I argue that medical writers need to carry the “knowledge torch” regarding how to consider and then act out various design intentions in regulatory submission documents.

Now please keep in mind, by “design” I do not mean making a document look pretty or to comply with a template. These are mechanical attributes of a document. By design, I mean how one builds and shapes arguments and how one creates division and hierarchy to convey meaning to the busy professional reader in complex, technically demanding sets of data and information. These are among the semantical attributes of a document.

My observations suggest many writers retreat from such tasks. They are very comfortable staying in the background operating in the manner of the monastic scribe versus the manner of the knowledge‑managing regulatory medical writer. They are most comfortable working to the model of “tell me what you want and I’ll write it” and the dictate of “here—write your document just like this one because it was approved by senior management.” I suggest this is an authoring approach that would appear quite comforting to an 11^th century Irish monk writing manuscripts in the monastery at Le Mont Saint-Michel.

So looking towards 2013 and years forward, I suggest that some of the things really good knowledge-managing regulatory medical writers will do are as follows.

• These writers understand that the mantra of “well this is how we have always done it” is not a meaningful metric—especially since regulatory agents in public forums and private sessions talk about how they sometimes gasp and choke their way through data and documents in submission packages. Good regulatory medical writers clearly understand that they are writing for a decision-making reader and look to get their teams to understand the implication of errant document design decisions for this type of reader. These writers understand how to design documents to satisfy the question-based inquiry of the decision-making reader of regulatory submission documents.

• Knowledge-managing regulatory medical writers truly understand the working definition of the term “concise” and look to influence their teams to recognize not only the importance of concise writing but the hallmarks as well. These writers know that writing style must vary by document genre and that you cannot simply take a “one shoe will fit all feet” approach to both style and level of detail as you move across various document genres. Their writing is marked by brevity of statement and is free from low-value elaboration and superfluous detail.

• Knowledge-managing medical writers recognize there is marked difference between descriptive text and expository text and assiduously avoid redundant representation of data in a textual form. These writers understand that much of descriptive text at best adds bulk and at worst adds noise to a document. They look to educate their teams to recognize much of traditional scientific writing style brings no added value to the domain of regulatory documentation, but will consume considerable amounts of time and energy to produce and manage within their documents.

I end this piece with a working definition that I feel is a good fit for the knowledge-managing medical writer—“the knowledge managing writer utilizes a range of strategies and practices with a team to identify, create, represent, and enable adoption of insights and experiences to foster effective work practices to create high-quality document products.”

Difficulties Assessing the Value-Added of Professional Communicators

Here is a post originally published in 2008, but the topic is worth repeating.

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

Something to consider: using intranets as Knowledge Management tool to support collaborative pre-writing planning

Jakob Nielsen is a name some of you may recognize. He is a self-appointed guru on all matters regarding usability of web sites and web-mediated work tools. You can find much of his work summarized on his web site titled Useit.

Last week Nielsen came out with his list of Top 10 designed business Intranets for 2011. Here's the link.

I noted with interest Nielsen's comment "If there's anything that has been overused, abused, and hyped beyond the level of cliché, it's "knowledge management." Thus, it might be better to say that many of this year's winners were strong in "managing knowledge" on their intranets." 

Managing knowledge. This is a concept where I see drug and medical device teams struggle all the time. One reason for the struggle is the slow uptake of tools that can help foster an effective work environment and change deeply ingrained cultural practices.

I believe intranets, such as WIKIs are great tools that should be deployed at the project team level. These platforms become incredibly valuable from the moment a clinical development plan is written until well after a dossier is submitted to the regulatory authorities. 

While it is true that knowledge management is not a technology issue, effort must still be spent in providing a suitable environment to facilitate knowledge capture and sharing. 

I am suggesting the use of team specific intranets as a way to promote cultural change in an organization, at the level of knowledge-sharing activities and also for shaping broader work behaviors. In most companies where I train or consult, little has really changed since the 1960s in how people approach the planning and authoring of documents.  Using intranets, like a WIKI, can quickly get a team applying best practices in terms of pre-writing planning.

Medical and Pharmaceutical Writers Must Use Knowledge Management Tools To Create Their Documents

In a past blog post I mentioned that full-time writers in the life sciences must see themselves as much more than just writers. I argued that writers engaged in pharmaceutical, device, and clinical research must see themselves as knowledge managers, not merely the managers of data or the "shapers" of information. I have argued that writers must do more to help control the knowledge environment. In this post I suggest writers must make use of knowledge management tools to help them represent the explicit, and more importantly, the tacit knowledge of a development or research project.

It is to this point that I want to bring to your attention two posts by Arjun Thomas on the excellent blog Project Management Tips.  The first post is titled Knowledge Inventory.  In particular, I like Thomas' discussion regarding the identification of tacit knowledge within a development team or organization. I believe it is critical for professional writers to see as part of their job the need to track and then leverage tacit knowledge within the documents they are tasked to produce.

In the second post Thomas talks about different methods to maximize the capture of both tacit and explicit knowledge. In particular I want to bring your attention to the concept of the Information Repository that Thomas presents. I suggest that as writers what you really want to create is a Knowledge Repository. This is something we do with project teams in our consulting practice at McCulley/Cuppan.


The Knowledge Repository as deployed by a writer is a structured table that keeps track of all the critical messages and issues that must be addressed in their document. The table consists of columns that track the following:

1. Messages the writer wants the reader to absorb and understand about the development work or research described within the report.
2. The issues (questions) the reader will likely have about each message and the nature of the development work or research described in the report.
3. The answers to each question.
4. The underlying rationale as to why each answer is the most appropriate response.
5. The specific data or precedence that supports the line of thinking described by the message, response, and rationale.
6. The subject expert(s) who best know the specific message and the data to be described in the report.

Constructing such a table will provide writers with a map, a map that frames the intellectual argument of a document as well as a map that directs them (and others within the team or organization) to the knowledge sources that must be mined to ensure the document fulfills the intended strategic purpose.
I am working with my colleague, Philip Bernick, on a project right now where we are guiding a client through the process of developing this type of Knowledge Repository. The repository now contains about 600 discrete rows of information. We are using the repository in a variety of ways. Principally as a tool for gap analysis and then as an organizing tool to map out the various sections of  a business-critical document that the development team must produce over the next nine months.

Highly effective writers working in the pharmaceutical and medical device industry understand the importance of using knowledge management tools. They understand that true knowledge retention is not an easy task and it is important to capture knowledge in a written form. They also understand that it is critical to have a well-defined method that is easy to use and scalable to the demands of the project or else you will end up with a mess, not a knowledge repository.


Originally published on our Knowledge Management blog

Building and Using Knowledge

Here is an interesting post by Dave Snowden at Cognitive Edge postulating his Seven Rules of Knowledge Management. In particular I am drawn to Snowden's Rule No. 7--

We always know more than we can say, and we will always say more than we can write down.

This is such a profound truism. The process of moving from mind to speech to written word involves moving through different media. And is in physical science this change in medium can result in signal decay. Unfortunately, this is a truism that should not exist, because there are writing tools designed to help capture knowledge and to help reduce the loss of knowledge.

The other rule I find intriguing is Rule No. 4--

Everything is fragmented.

Snowden postulates that humans are wired to deal with fragmented information in an unstructured environment and this is why we have problems working within the confines of highly structured documents. An interesting theory. I am trying to find more research on this topic. If true, then when I see my clients struggle with their document templates or engage in reviews best described as chaos I can just sit back, sigh, and say: "well they cannot help it, they are just wired that way."

All kidding aside, Snowden observations are worth keeping in mind whenever you want to plan a large collaborative project or map out work processes, especially documentation processes.


Originally published on our Knowledge Management blog