Taking the Plunge – My First Steps as a Medical Writer – Justin McLaughlin, CEO of Acumen
My journey into medical writing started when I was in my mid-twenties, attending graduate school in Boston and working, when I could, as a freelance writer. In early 2003, I took a 3-month editing assignment at Sepracor (later purchased by Sunovion) to work on the upcoming NDA filing of Lunesta (remember the Luna moth? https://www.youtube.com/watch?v=kWdt7yn2BoU).
This initial gig was extended to 6 months and then to 1 year (thanks to @Donna Gillian-Brown, the Director of Medical Writing, who gave me a chance). I had no experience in drug development and each new regulatory document plunked on my desk was an event. But as an editor, thanks to expert training from Karen English at Emerson, I knew I could help tighten up the submission. I learned my way around data tables quickly.
My first true writing assignment came from Paul Miller, the lead writer for Lunesta. My task was to write about 400 patient narratives in a month. These were the days before electronic patient profiles or other data programming aids; instead, someone from “downstairs” wheeled up carts stacked with rows of 6-inch binders which contained the paper printouts of the patient listings. To complete everything on time, I needed to complete 15 narratives a day; my medical friends John Hanrahan, Donna Grogan, and Janet Price helped me a great deal. My medical writing colleagues Dora Cohen, Paul Miller, and Amy Wilson were also indispensable. Chris Cameron, who shared a cubicle wall with me, lent his expertise in human physiology to help me through some dark territory.
Due to resourcing challenges and the lack of experienced staff (a constant challenge for drug developers), I was then thrown into the deep end of medical writing, tasked with leading the development of protocols, clinical study reports, investigator brochures, annual reports, and even more patient narratives for Brovana and a few other novel drugs under investigation.
It was daunting; there were times when my confidence was on the ropes, but I ultimately gained purchase through the support of my colleagues. I asked a lot of questions. Sometimes just being in the room where it all happened made the difference, like watching the statistician Ken Sciarappa and the medical lead John Hanrahan duke it out over alpha spending at the interim analysis. In the end, the cross-functional team became a collective mentor.
As I tell all aspiring medical writers, to be great at this job requires one to know a little bit about many disciplines: clinical science, safety reporting, regulatory guidance, statistics, and clinical operations. Most regulatory documents are a melding of detailed information from experts, and the medical writer sits at the center of a web, ensuring the whole is cohesive and consistent and well messaged. Writers can help their teams by asking questions, looking for gaps and inconsistencies, and keeping the bigger picture in mind. Clinical documents are very technical, and teams sometimes have trouble reducing the content to the essential elements and ensuring those components are aligned with the intended audience, such as the FDA, journal editors, clinical site, or patients.
As a kid I would never have anticipated I would build a career out of writing for the pharmaceutical industry. And yet it happened, and I am proud of the knowledge I have gained. At Acumen we are fostering a new generation of writers and editors (Aaron Slyman, Lindsay Larkin, Jamie Spagnuolo) and it’s really fun (and a bit nostalgic) to watch them gain these valuable skills and experience.
