Interview with Karen Fuerth, Medical Writer at Roche Canada

What has been your career path leading to your current position?

I completed a Bachelor of Medical Sciences in Biochemistry at Western University, and a Master of Science in Biochemistry at McGill University. Right after completing my Master’s degree in 2010, I began my first medical writing job. I have worked in a number of areas within medical writing during my 7-year career, including sales rep training, digital marketing, and regulatory. I’ve spent the majority of my career in regulatory medical writing though, first working at a contract research organization, and now working at Roche.

What does your current position at Roche, as a regulatory documentation scientist, entail? And how is it different compared to your previous positions as a medical writer?

I work in global product development at Roche, a major pharmaceutical company. I write a variety of regulatory documents to support submissions to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A few examples of documents I write are clinical study reports, investigator’s brochures, briefing packages, and summaries for Investigational New Drug applications.

Working directly for a pharmaceutical company is a lot different from working at a contract research organization or agency. The company is much larger, and I work with colleagues around the world. I also collaborate with colleagues in many different functions, such as clinical science, safety science, toxicology, clinical operations, and technical regulatory. I have learned a lot about the drug development process in my 2 years at Roche!

 Why did you want to become a medical writer? Was there anything that you did during your undergrad or graduate years that prepared you for this role?

When I was a grad student, I attended a panel event through the McGill Career Planning Service where people with advanced life sciences degrees who work outside of academia spoke about their careers. This was my first exposure to the field of medical writing. As I listened the panelist who worked as a medical writer describe her career, I knew immediately that this field would be a good use of both my language skills and my scientific curiosity.

My favourite part of grad school was writing my thesis. I also had the opportunity to co-author a chapter for a medical textbook as a Master’s student. I think that everyone who completes a graduate degree in the life sciences gains valuable experience that is directly transferrable to a career in medical writing. You already have a writing portfolio: your thesis, grant/scholarship applications, and publications.

 What qualities/skills do you think that a medical writer should have?

The single most important quality in a good medical writer (which can’t be taught) is attention to detail.

Other important skills, which can be learned on the job or through self-training/classes, include:

  • basic grammar and punctuation (the American Medical Writers Association has great study-at-home guides to brush up on these skills)
  • advanced Microsoft Word skills: using styles, macros, cross-references, and fields (you would be amazed what you can learn from YouTube!)
  • soft skills such as conflict resolution, meeting facilitation, and leadership
  • knowledge of the regulations governing the field of medical writing in which you are working (e.g., International Conference on Harmonisation [ICH] guidelines for regulatory medical writing)

 What are some of the key challenges (or things that you enjoy the least), if any, that you have faced being a medical writer?

It is a very deadline-driven job, no matter what field of medical writing you work in. It can be frustrating to work really hard toward an arbitrary deadline, and then learn later on that the overall timeline for the project has been extended for other reasons. In my current role, I do a lot of collaborative authoring, where people from different functions write certain sections of the document. It can be challenging to follow up with people who don’t provide their input on time —especially when working across international time zones.

 What other professions would you like to attempt if given the chance?

I love working in regulatory within the pharmaceutical industry. The industry is constantly changing, and it is really stimulating to keep up with the shifting regulatory landscape and with the company’s fast-moving pipeline. I’ve been learning a lot about regulatory strategy through my work in documentation. Someday I might like to explore a career in regulatory program management or another regulatory sub-function.

 Three pieces of advice which you would like to give to graduate students or your younger self.

#1: You don’t have to know now exactly what you want to do for the rest of your life. You’ll develop transferrable skills in every position you hold, even if you don’t intend to stay in that particular field in the long term.

#2: You don’t need to complete more schooling to develop the skills required to start a career in medical writing. You already have writing experience and scientific knowledge. You will learn so much more on the job than you ever could in a classroom, so get started!

#3: It is never too early to network and apply to jobs. If you’re a grad student who has made the decision to pursue a career outside of academia, start networking now. And take advantage of your university’s career services to get help with your resume and cover letter.

Written by LSCDS Exec Member Brett Wang 

Brett is a MSc candidate in the department of immunology, pursuing his research in the lab of Dr. Naoto Hirano. He is interested in the career of Medical Affairs or Consulting.