I looked at my boss blankly. “You have to understand,” I said. “As an academic, I’m used to writing a lot of things that no one reads.” She laughed. “No, really,” I said, all earnest. “Not just like humanities publications, but also assessment reports . . . all sorts of reports that you have to write but that no one reads. The comments on papers I’ve graded. I think maybe only one student in each class ever reads those.”
She had just told me that I should add a footnote explaining how I got the percentage I reported, since I had to do some simple math to derive it from the data presented in the medical article I was summarizing. “When the reviewer for the Notified Body reads these, you want to make their job as easy as possible,” she told me.
People ask me what the heck I’m doing these days, as “medical writer” covers an awful lot of territory. To be more specific, I’m doing what’s known in the field as “regulatory writing.” To be even more specific, I’m writing the literature review sections for Clinical Evaluation Reports (CER) to be submitted to the European Union as part of the continued post-market follow-up that is necessary to keep medical devices on the market in the EU. For each medical device, at intervals that depend upon the riskiness of the device (e.g., more frequent reports are required for implantable devices that stay in the patient permanently), someone needs to determine what clinical evidence has been published about the device since the last report was submitted, research the “state of the art” (“SOTA”; i.e., the standard of care) of that particular field, and contextualize the clinical data from the published literature with regard to the state of the art.
I laughed in an earlier blog post about how my job title includes the root for “science” not just once but twice (my official job title is “Scientific Communications Scientist”). And yet, now that I’ve been in this job for six months, I can see that regulatory writing comes as close as I can imagine to writing-as-science. It is methodical to the point of plodding, detailed to the point of OCD (and I kind of love it). Searches of medical databases must be replicable and must be documented. Everything that comes up in a search must either be included in the final report or excluded, with a reason for exclusion provided. If my report includes a percentage or figure that is mentioned in four of the publications I am including, then I must cite all four publication, not only three of them. This is writing to prove, not to persuade (although there is as always an element of rhetoric even in these reports) . . . writing as science.
What I like best about the job, in comparison to being an English professor:
- The sense of teamwork. A couple of months ago, the CER for a guidewire had a tight deadline. My colleague T modified and updated the SOTA that my colleague D had done for a different guidewire a few months earlier, and M, the newest medical writer, did the quality check (i.e., technical editing, which involves not only proofreading-type stuff but also checking the accuracy of claims against the original articles cited). I did the clinical evidence section, and D did the quality check. All four of the medical writers lined up in our little row of cubicles worked on the project, and it was . . . weirdly fun to pull together to meet a tight deadline. And this is just a more extreme example of the everyday teamwork on any of our projects, which involve a lot of back-and-forth between me as the writer, the medical reviewer (who has an MD, provides medical context, and serves as the overall decider), and the editor.
- Not having to defend the value of my work. When I was job-hunting last summer, I was doing searches for any job that had the words “writer” or “editor” in the name . . . but I ignored all jobs for advertising writing. Although I was tired of the general public thinking that the work I did as an English professor wasn’t valuable, I wasn’t ready to take a (possibly better remunerated) job that *I* didn’t think was valuable. Regulatory writing, on the other hand—writing reports aimed at proving the continuing performance and safety of medical devices with reference to the state of the field as it is today, participating in a regulatory system that ensures that medical device makers fulfill their obligations to create and market products the benefits of which outweigh the risk—hell yes, I can get on board with that.
I’m writing this blog post in response to a friend who asked about “the advantages and adjustments” of this post-academic job. The main advantage is that I feel less ambivalent about the necessity of my work—the fact that manufacturers have to write the kind of reports that I work on now keeps them honest, keeps them focused on their responsibilities to the public, and I feel good about being part of that. [If you’re curious about why the EU is upping its regulatory requirements for medical devices, check out the story of the Poly Implant Prothèse scandal here, or else listen to the Swindled podcast episode titled “The Implants.”]
I haven’t experienced the main disadvantage yet, but I’m already sniffling about not having freedom and autonomy in the summer. Everyone who knows anything knows that academics work hard in the summer . . . but they don’t have to show up at a particular place at a particular time, and that’s heaven. And just in general, yes, I have less freedom and autonomy, because I work in a cube now instead of an office with a door that closes. The Panopticon is real—I do a lot less messing around on the Internet now than I did when I had an office with a door that closed . . . but on the other hand, the expectation in that job with the door that closed was that I’d be working evenings and weekends, and therefore I could do whatever I wanted with my time in my office, because I’d be making it up later no matter what. I don’t work evenings and weekends now, and that’s another big advantage.
As I’ve spent the past year or two contemplating an exit from academia, I’ve veered between two different thoughts about being an English professor. I’d think of the coal miners that Donald Trump said he wanted to prop up in order to get their votes. “Am I a coal miner?” I’d ask myself, wondering what it means that this nation’s educational system has decided that the majority of the people who teach our kids English language, writing, and literature don’t deserve tenure . . . or benefits . . . or job security.
But then, goddess help me, I think of Ayn Rand. I went through an Ayn Rand phase as a 15-year-old, as many dumb smart kids do. I think about the characters in Atlas Shrugged, who are like “Fuck y’all—you think you have a right to my work, my mind, my passion for this thing I do, but you want to just take it, and you don’t value it,” and, more so than at any other time in the 30+ years since I got over my Ayn Rand phase, I think, “Yeah.”
[Part 1 of this topic: “Leaving Academia: My Prehistory”]