Answers to all your recent questions!!!

Yes, it's been a bit, which I'd apologize for but by now most of you have seen that I've been in the midst of a rather large shift in work responsibilities. Interesting enough, the very move delaying this edition is also the topic of it. You make one little post about moving into AI, and suddenly doors come off their metaphorical hinges with queries, requests, and warnings :)

You're right to ask these questions, many of which I asked myself a lot the last few months... what IS it like to work alongside generative AI? Well, I can tell you I'm definitely not the brains behind our team but wow do we have some. It's a steep learning curve for an attorney who lives in regulatory, which for me is always exciting. I crave drinking from the fire hose in some ridiculous settings, and this isn't for the easily stumped. Capacity is exhilarating, but, alas, there are limits and there are good reasons for caution. Also, why do so many approaches to the use of AI do so without factoring in human use alongside the LLM? I think I actually have more questions than answers, ha!

While in no way a SME, I've always admired using tech forward solutions to optimize our environments and remain a bit aghast others don't always share similar opinions. The better question to ask here is what it is like to work alongside an incredibly passionate, creative, responsive, transparent, nurturing and humbling team on a daily basis. (HINT: It's amaze)

What is with your new job title? Why would a reg person be in customer service with a startup? Ummm, why NOT?! Sure, having a reg expert at a company focusing on reg optimization makes sense, but Customer Success? When you're a company dedicated to addressing regulatory inefficiencies utilizing artificial intelligence, understanding clearly what support your end user requires to be successful is mission critical. And that end user may not be a technical person, AI expert, or even the person acting as the decision maker about utilizing our product at all. Rather, it's more likely to be someone closer to regulatory. Wouldn't you want to see support as an end user that actually knew your plight? Had been in your shoes? And while we are on the subject of customer success, why the heck AREN'T more regulatory folks focused on this skillset. Just because regulations must be followed doesn't excuse a lack of white glove approach to the 'customer' in any setting.

It's also personal for me in my own career journey. If we've so much as crossed paths for even an instant, you'll know how much I highly value relationships and continuous growth. One of the lessons I've learned time after time in this industry is never to become static. The dynamic approach is critical to the very crux of what we are attempting to do within clinical trials ~ innovate. If you wish to drive that change, you have to be prepared to buckle up and put it in 4WD. Similarly, each prior experience I've had contributes to the potential I can add to our industry today, but to ensure I still increase the value prop in the future, I have to seek nuanced and disruptive opportunities. Challenging my own knowledge base, pushing my mental capacity far from my comfort zone.

So you aren't in compliance anymore...? Of course I am silly! One doesn't lose years of experience all in one job pivot, rather, I'm adding to that repository and creating new pockets of SME to layer and intertwine with my compliance mindset. But I've never been shy about surrounding myself with folks who are far and away more talented than myself AND who come from wildly different backgrounds than my own. The best part - you can approach your differences to learn from one another at a distinctly faster pace than you could alone. Folks just have to want to learn, share, and contribute as a collective without tripping on their own egos.

Compliance is exactly what I'm very much still doing each and every day. Helping a new team of motivated change makers push the boundaries of what's possible to improve patient outcomes while ensuring regulations are appropriately respected. Intentionally testing new approaches for weaknesses before deploying them as solutions within our regulatory community. Focusing intently on providing a product that allows for not only an expedited timeline and alleviates burden, but that can also quite possibly change the quality and way with which we approach one of the most important compliance components in drug development globally.

Didn't answer your burning question? Put it in the comments!