Speak Previews^® interviews Michael Vivion, PhD, about his chapter "Harmonizing Strategy and Tactics for an FDA Advisory Committee" in the recently published Global Pharmaceutical and Biologics Regulatory Strategy and how the information it contains generalizes to many types of business writing.

SP: You came to ECG with experience in rhetoric and composition as well as in regulatory aspects of pharma. How do these forms of expertise converge in the work you do at ECG?

MV: Before I began working in pharma as a regulatory communication expert, I spent 10 years as the Director of Composition and Rhetoric at the University of Missouri/Kansas City. Our program required a writing course during each of a student's first three years. One of our primary goals in each course was to help students understand that every writing assignment or task required them to develop a distinct strategy and then employ tactics that allowed them to realize that strategy. This goal hasn't changed too much in my work with the people in the industries that form ECG's client base.

SP: The emphasis is still on strategy?

MV: Strategy first, yes, and then using the tactics that bring the strategy to fruition. We encounter lots of writers who repeatedly compose the same document: responses to RFPs, reports to senior management, regulatory options or applications, articles for publication. Many of these writers are excellent at crafting sentences and paragraphs, at explaining complicated science or processes, at editing complex texts. Yet many of the documents they produce fall into that range of quality that we might call "satisfactory." Although they meet the basic requirements of the document type, many lack the spark that would raise them to the level of excellence. That's the level that gets noticed—in a good way.

Perhaps paradoxically, this failure to achieve excellence often lies in the writers' extensive experience. They've written so many similar documents, or have used models as templates, that they forget that composing another requires them to revisit two of the driving considerations required to produce an excellent document—purpose and audience.

One example. Every response to an RFP superficially has the same purpose—to provide information persuading a potential client to become a client. On a deeper level, however, anyone writing an RFP has to know where the readers should have "aha" moments. If the company has the expertise required by the RFP but little experience, for instance, the writer has to understand the need to emphasize that expertise. In such an RFP, the writer's purpose would be to persuade the potential client to accept the company's relative lack of experience in a particular area but place high value on the company's ability to use its extensive expertise to adjust to any situation.

SP: How does a writer do that?

MV: To understand just how to shape and address this particular purpose, the writer has to know or postulate something about the expected reader. Has the potential client used a variety of types of vendors in the past? Do the decision makers have backgrounds similar to the company personnel who would deliver the proposed service? Do the company personnel have a generally recognized reputation in the area of the RFP? Does the potential client have the reputation for taking risks?

We're talking more than strategy, of course. We know that really good writers must create the right vocabulary, construct sentences and paragraphs that match the expertise of the readers, find examples that resonate, and generally match other characteristics of good writing to the audience.

In my chapter on preparing for an FDA Advisory Committee, I discuss the briefing document, which is one of the documents that many good medical writers often have difficulty writing because they have trouble understanding the purpose and audience that drive this very special kind of writing. In that they're not much different from writers in other industries who are asked to write something new to them or to write for a new audience.