After completing a 2-year post-doctoral fellowship in medical affairs, I made a big transition into regulatory affairs and now hold a full-time position as an Oncology Global Labeling Lead at a large pharmaceutical company. This post will walk through a day in my life, and I'll shed some light on what this position entails!
Morning: Benefits of Remote Work
I typically wake up whenever my newborn does, which is normally between 4am and 6am. The first thing I do is make coffee, but that's about the only consistency I have anymore. My morning routine used to be much more of a "routine", but now I'm just thankful for my job's flexibility! I don't have to wear nice clothes or commute for my job, which is a huge plus. This allows me to feed the baby, have some daddy-daughter play time, and get her ready for daycare while my wife gets ready for work. Having said that, I try to be online by 8am every day since my team follows eastern standard time and I'm located in the Midwest.
What I Actually Do
In general, global labeling is a very strategic functional area requiring much attention to detail. There are 3 main labels including our core position, the United States Prescribing Information (USPI), and the European Summary of Product Characteristics (EU SmPC). Each of these also has a corresponding patient information leaflet. The main labels help guide our approaches to the rest of the world. Different countries like Brazil, Korea, or Switzerland might choose to align with the USPI or EU SmPC, while other countries may have very specific labeling requirements and choose to do their own thing. Some countries may want their efficacy text aligned with the USPI while all of the safety information follows the EU SmPC. Every country is a little different.
As medications make their way through the development process, we start drafting labeling. This requires intense deep dives into phase 2 results, phase 3 protocols, investigator brochures, competitive analysis of other medications on the market, constant interaction with subject matter experts (SMEs), and many hours of discussion on strategy and language.
For drugs that are already on the market with newly approved indications, label updates have to occur in our core position and the other major labels. This has a major downstream effect as every country in the world with approvals for that drug will have to go through a rigorous update process. This is what drives a lot of my work currently, especially since oncology is a fast-paced environment with new approvals occurring constantly.
Updating prescribing information requires that I run large meetings with a number of stakeholders across the company. This can include any number of people depending on the update. For instance, I may need to discuss strategy with touchpoints from clinical, safety, legal, marketing, regulatory, statistics, and translational medicine for one update. Oftentimes, these touchpoints include interactions with senior leadership and VPs. These meetings can very easily go off the tracks, so the ability to steer a discussion with stakeholders that are far higher on the totem pole is an important skill. Having said that, if you enjoy intense discussions with very smart people, this is a great job to pursue!
As you can imagine, this role also requires frequent interaction with health authorities around the world (FDA, EMA, SwissMedic, etc...). Each health authority is a little different, so we'll have local experts help guide us through those discussions.
All in all, labeling is a fast-paced, intense, and strategic functional area that requires clinical aptitude, soft skills, and attention to detail in order to be successful. It's a great space for PharmDs, and pharmacists have become integral members of labeling teams across the pharmaceutical industry and at the FDA.
Evenings: The Art of Disconnecting
Around 4pm CST I get in a run or workout, do laundry, and do my best to forget about work. The evenings are for family, and I like to make sure I'm actually "there". I'm not always successful, but practice makes perfect!