How did you begin your career in health care?
After graduate school, my first job was conducting research and development on a novel hemoglobin therapeutic product at Baxter Healthcare.  After several years at the bench, (much of it in a cold-room lab!), I moved to a role assessing biocompatibility of medical device materials, leveraging my toxicology background.  I was hooked on health care early because of the opportunity to make an impact on the lives of patients whose needs weren’t being met by current technology or science. 

As I became more curious about the work happening upstream and downstream of my biocompatibility assessments, I wanted to understand how these reports were being used to get our products to market.  A role opened in Regulatory Affairs (RA) and I took the leap that ultimately changed the course of my career.  It was a great fit for my skills and interests, marrying my love of science and my natural inclination to tell stories through writing – shifting to telling the story of a product’s development and why it will benefit patients who are waiting.  While my roles have changed over the years, I’ve always stayed in companies that are focused on serving patients.

You attended the WBL Board Program last year. What was the most important takeaway from the event?
Understanding and accepting that you need to start preparing for board leadership years before you intend to take on board roles!  A real aha moment was realizing I can’t solely rely on the reputation I established to ensure consideration.  It became clear that building a strong network is critical to being on the radar for board roles. It’s also clear there are tools and practices you can deploy to help you better explain your board readiness, and that it’s not the same as the tools/practices you would typically use in a standard job search.  If you are looking to learn more, I recommend participating in this program the next time it is offered.

As someone who works internationally, how has the ‘new normal’ impacted your approach and ability to work with people around the world?
I went from traveling 3-4 times a month to no travel at all!  And while I really miss the face-to-face interactions with my team and our regional business partners, I’ve found that technology has really progressed, enabling rich interactions, even via videoconference.  I’ve adapted, as have my teams, and after making a few adjustments, we can get our work done in this remote environment.  Even the work with global Health Authorities who review our regulatory submissions has continued without major disruption. In fact, we’ve been able to leapfrog our use of digital enablers by years based on the need to respond to the pandemic.  I don’t think we’ll return to the ‘old normal’, and that’s a good thing as it has challenged us to innovate how we work while providing us with the balance we may not have realized we were missing. That’s certainly true for me and I will be looking to better balance travel with time at home in the future.

What you can’t do remotely is learn about a culture – you need to be immersed in it, so when it’s safe to resume travel, I look forward to being with my colleagues and customers around the globe, just maybe not as frequently as I did in the past.
 
You have extensive experience in Regulatory Affairs and accelerating market roll outs.  What advice do you have for WBL members who seek to innovate and problem solve in a highly regulated industry?
To innovate in a function like Regulatory Affairs or to innovate in highly regulated industry is not different from innovating in other functions or businesses – there are several things that are key:

1. Foster a culture where assumptions are challenged. The more you have people asking ‘why’, the more chances you have to get to the heart of the unmet need or opportunity.  You can challenge ways to address data requirements for regulatory submissions, explore and rethink the avenues available for your products to reach the market, and even advocate for changes to regulations that stifle access to medical products and services that are needed by patients, as long as you keep the goal of protecting public health in mind.
2. Iterate and build upon ideas as you go, don’t wait for the final product. Giving immediate feedback throughout the process of building something is always better than waiting at the end to ask what you might have done differently.  Whether it’s product or strategy, timely input from a diverse team always results in a better outcome.  Applying lessons from one market to another, even where the rules are different, may accelerate your launch.
3. Set boundaries but give people the freedom to find their own path.  You’ll better tap into employees’ creativity and innovation if you remember that what your employees need is clarity about expectations.  You can leave it to your organization’s culture and values to guide the team to the best route to achieve the desired goal. 

Personally or professionally, what might the WBL network be surprised to know about you?
I’m passionate about helping develop women leaders and to promote diverse and inclusive workplaces.  I chaired the Board of the Central NJ Chapter of the Healthcare Businesswomen’s Association and was the Women’s Leadership Initiative Chair in my role at Ortho Clinical Diagnostics.  I divide my free time between being a mom to two teenage boys and connecting with friends and family when not under quarantine!