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Eight Things About Regulatory Medical Writing That May Surprise an Academic

August 30, 2019 | Nicole Tackmann, PhD, Clinical Research Scientist II | Medical Writing Services

The process of moving from the world of academia into the world of regulatory medical writing was an exciting and scary time for me. Luckily, I found a great place to make the transition, and I started my medical writing career at IMPACT in late 2017. At the time I thought that I had a pretty good idea of what regulatory medical writing was, but of course, I’ve learned a lot along the way!

Image courtesy of Jolee G at FreeDigitalPhotos.net

In this post, I share 8 things that surprised me during my transition from academia into regulatory medical writing. Keep in mind that there are many types of medical writing  and different work environments for regulatory medical writers, and aspects of this post may be specific to working as a regulatory medical writer at a contract research organization (CRO).

  1. Regulatory medical writers spend a lot of time doing things other than writing.

    Although we do spend a lot of our time writing, on any given day we might also be preparing for or running a roundtable meeting to resolve comments or issues with a document, preparing or updating project timelines, organizing reviews of documents, reviewing documents authored by other writers, emailing Sponsors for information or clarification, reading up on new regulations, answering questions from colleagues, and more.

    Every day is different, and the work required for every project is different! If you are thinking of transitioning into medical writing, you should know that these tasks do not “get in the way” of your writing; interactions with coworkers and Sponsors are an integral part of developing quality documents and keeping your projects on track.

  2. Regulatory writing projects tend to be much more discrete than academic projects.

    In academia, many have described the temptation to perform “one last experiment” to either add to a publication or to support a grant application. Regulatory writing projects tend to be more defined, and more often than not there’s a distinct point by when the project needs to be completed (eg, a regulatory deadline for the given document).

    Medicinal products in development are always being assessed for their value, and a clinical development program could be terminated for business reasons at any time. Sponsors like to plan their clinical programs with both business and regulatory deadlines in mind. Because of this, we generally agree on the scope and duration of a project with the Sponsor before writing begins.

  3. Regulatory writing projects move fast, and the documents we write are often a lot longer than most academic writing projects.

    I knew when I first started at IMPACT that I would be working on projects that would be completed more quickly than academic projects, but I was surprised to learn that some medical writing projects may only last a few weeks! There is a lot of variability, but most individual document timelines last approximately 2‑3 months (marketing applications [ie, NDA/BLAs] comprising multiple documents are on longer timelines).

    In addition, you may be surprised to learn that we regularly write 200+ page documents! These large documents, in combination with short project timelines (relative to academic research projects), are possible in part due to the team‑based nature of industry and clinical research. As medical writers, we bring together teams with expertise in a wide range of subjects (eg, from statisticians to regulatory experts). When many people are contributing to the same goal, incredibly large projects can be completed much more quickly. Standardized templates based on regulatory guidelines (see #4 below) also aid in the production of large documents on short timelines.

  4. Regulatory medical writing tends to be more formulaic and structured than academic writing.

    Image courtesy of alongkorn1622 at FreeDigitalPhotos.net

    This is a very strategic choice! Medical writers want to make sure that the document we are writing is consistent with other documents in a clinical development program and with the messaging of the program as whole. Often, we can borrow text or phrasing from other documents in a clinical program and adapt the text to fit the document that we are writing. Because the documents we work on can be rather large (see #3 above), this way of working also helps us to write more efficiently.

    Regulatory agencies have to read many documents in a short time span, and they are used to seeing documents organized in certain ways; this contributes to what some might say is the more “rigid” nature of clinical/regulatory documents. As regulatory medical writers, we tend to “state the facts,” without a lot of the interpretation that you may find in an academic paper. Since “stating the facts” can be done in very similar ways across documents, we can often adapt text from one document to fit another very easily.

  5. Sometimes medical writers have to be social psychologists.

    We get to work with diverse teams from all over the world, which means that we often encounter differing team dynamics across our projects. This can sometimes make projects challenging (for more information, see Caroline’s post in which she describes some personality types that we encounter). As medical writers, we are responsible for leading discussion and helping drive the team to consensus to produce a document that is fit for purpose.

    In general, medical writers must not react emotionally and should be comfortable with criticism of their work. We may not always agree with a team member, but we must recognize they are recommending a course of action for a reason. Though team members may provide conflicting advice on how to revise the document, it is the medical writer’s role to ensure that the team agrees on a path forward. It helps to try to understand both what the team member’s functional area needs from the document, as well as what is required from a regulatory perspective.

  6. Medical writers are not typically subject matter experts, but Sponsors often consider us document experts.

    Though medical writers don’t generate data, we work to communicate knowledge and are often asked for guidance on how to best present ideas (even though we may have been working on a project for just a few days/weeks). This means we have to know what has been said already, the rationale for the language that we chose, where new or edited material would best fit within the document, and how the document is meant to convey information to its specific audience.

    Because medical writers are the most familiar with a given document, Sponsors rely on us to know what messages we’ve conveyed and where we have conveyed them. But because we are not the subject matter experts, we have to know how to solve problems and get the information we need (eg, whether it’s clarification on what a particular piece of source material means, or finding out how to interpret a statistical test).

  7. We often write about “negative” results (ie, results that show no difference between test products).

    “Negative” results are actually very important in clinical development – they are critical for determining the benefit:risk ratio for a given product! For example, depending on the therapeutic area, a Sponsor might hope to see “negative” safety results (eg, little to no difference in safety signals between test products). On the other hand, “negative” results can be problematic when describing a product’s efficacy, as we generally hope that the test product is different from the standard of care (or placebo) in a way that provides a benefit to the patient. Either way, though a study may fail, the Sponsor is required to report the results (positive, negative, or somewhere in between), and we must describe these data.

  8. Medical writers can have really flexible schedules!

    In my experience, people in academia tend to think that academic positions allow much more freedom in their work schedule than industry positions would. This will certainly differ by company, but many medical writing positions allow their employees to work from home and give them the option to work flexible hours. In many cases, we work when it is most convenient for us or the Sponsor (which can mean 6am meetings if a Sponsor is in a time zone 12 hours ahead of ours). Our primary concern is that the work is done, and done well – not when it’s done (as long as it’s on time)!

    You may think that this type of schedule could make our work/life balance difficult, but the flexibility allows us to choose a work/life balance that fits our needs (and the 6am meetings are usually rare). Some writers, for instance, choose to work a more regimented schedule so that they can “turn off” their work brain at the end of the day, while other writers work more fluidly throughout the day to accommodate the schedule of their lifestyle.

If you are interested in becoming a regulatory medical writer, please check out our Fellowship Program! If you have questions, or are looking for an author for your regulatory documents, please don’t hesitate to contact us at IMPACT.

Category: Medical Writing Services

Keywords: medical writing, regulatory medical writing, career transition

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