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 11th
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.”
