The following is a re-cap of an iJOBS event—Regulatory Writing Workshop—held on January 30th, 2018 on Busch Campus. Doreen Lechner, director of the Biopharma Educational Initiative and Clinical Trial Sciences Program at Rutgers, moderated the event and provided information on relevant courses offered at the university. Artur Gertel, Principal at MedSciCom, LLC; Diane Petrovich, Head of Medical Writing Infectious Diseases and Vaccines at Merck; and Ketra Volcy, Medical Writer Consultant, formed the panel of experts that answered questions about working in regulatory writing. Rupal Patel, Senior Manager of Regulatory Affairs at Chugai Pharm, introduced the concept of an investigational brochure and led the workshop activity. Qing Zhou, President of American Medical Writers Association of the Metro New York chapter, also spoke about the wonderful networking opportunities in this field.
Before attending this workshop, my assumption was that any job description with the term “writer” in it, involved someone working in isolation, pouring over documents and barely speaking a word throughout the day. Surprisingly, my perception completely changed after listening to a panel of experts at the Regulatory Writing Workshop. Each of them stressed how their roles are really part of a team effort.
One of the main responsibilities of a regulatory writer is to compile all the information about a drug in development, including results from non-clinical (mechanistic, interaction studies, etc), pre-clinical (animal studies) and clinical (Phases 1 through 4) studies. This encompasses a wide variety of clinical documents. With such a broad responsibility, they must interact with all of the separate departments and individuals who perform these various activities during a drug’s development. In fact, the panelists agreed that a big portion of their days are spent in meetings, because they are extracting useful information from all of the people performing these different roles. Clearly, my perception of writers working in isolation was incorrect!
Other insider-information that was offered up by the panelists was that occasionally, there can be long work-hours, especially when there are tight deadlines. Unfortunately, this sometimes happens, as writers’ tasks fall near the end of the timeline, as they await information from upstream sources, to compile and incorporate within documents. The panelists agreed that the silver lining to working on a deadline is that it enhances a sense of teamwork. Other information that was shared from the panel was that, regulatory writers can oftentimes work-from-home, which can provide some flexibility and improve work/life balance. In the end, what makes it all worthwhile is that the work of regulatory writers is highly meaningful and impactful to patients.
As the workshop continued, attendees were given the opportunity to play the role of regulatory writers through a hands-on activity. In groups, we were given thick packets that contained information about a certain drug. From that, we were to extract details that were relevant to include in an investigator’s brochure (IB). An IB is a document (~150 pages) that contains all clinical and non-clinical data of a product relevant for use in humans. It is a living document, meaning it is constantly being updated, even after a product is on the market, to include key information about its safety and efficacy in humans. It is provided to all investigators involved in clinical trials with the drug. Some information that is included in the document is in regards to drug indications, reported side effects, mechanism of action, pharmacokinetics and more.
What struck me the most about the hands-on IB activity was the high level of detail that is recorded for each drug. In industry, it is important for this information to be readily accessible, as the goal is for the product to be approved for use in humans. The more that is known about a drug, the safer its administration and use can be. After the activity, each group offered their opinions about the experience. There was a general consensus that regulatory writers must be very detail-oriented, possess a high level of scientific understanding (perfect for PhDs and post-docs!), and be able to summarize information in a clear and succinct manner.
For those interested in learning more about Regulatory Affairs, Rutgers offers certificate (15 credits) and masters (36 credits) programs as part of the BioPharma Educational Initiative. There are also four other tracks: Medical Affairs, Clinical Trials Informatics, Drug Safety and Pharmacovigilance, and Clinical Trials Management and Recruitment Sciences. Courses are entirely online, and are attended by many industry employees, who provide a relevant, real-world industry perspective in the discussion to complement the coursework! If you think you would like to participate in these courses, consider taking them as part of Phase 2 of iJOBS! Another valuable resource for those interested in this career path is joining the American Medical Writers Association. There is a local, New York chapter that offers networking events and workshops to help you build connections and skills to be successful in this field! Make sure to take advantage of opportunities like these – such as extra courses or membership in a professional society – that provide you with unique experiences, and also help you stick out on your resume as you apply to Regulatory Writer positions!
Edits and suggestions that contributed to the development of this post were made by fellow bloggers, Jennifer Casiano and Maryam Alapa.