Episode Transcript
2.6.26 Em Stephens.mp3
Transcript
00:00:02 Speaker 1
Welcome to Chasing Compliance, the global regulatory podcast, where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy, from bench to bedside.
Today we are chatting with Emily Stevens, the founder and CEO of Global. Emily worked in the medical device and biologics industries for 13 years before launching Global in early 2014. After years of 60-hour work weeks for CROs that were notorious for burning out workers, she developed an autoimmune disease that would forever change her vision of the medical writing industry. Life was too short for burnout. She wondered, what would happen if there was a company that treated workers with respect, loyalty, and deeply advocated for their work-life balance? Out of this question, Global was born, and the outcome has been spectacular. We attract the best, who then perform at their best, because this is a place where we fiercely take care of each other. Thank you so much for being here, Em. On this episode, we are exploring 2026. What are we looking forward to? What are we looking out for? And what opportunities exist? So let's dive in.
00:01:05 Speaker 1
Yay! So glad to have you here.
00:01:07 Speaker 2
Great to be here.
00:01:08 Speaker 1
So as we kick off this new year, what are you most looking forward to as the CEO of Global?
00:01:15 Speaker 2
Oh, great question. 2026, the great unknown. This for us, for Global, is going to be the year of relevance. We have decided to actually add relevance to our core values as a company. And so what's that mean? What does relevance even mean? For us, it means it's not a state of being relevant, but it is an act of constantly seeking to gain the knowledge and the experience necessary to remain relevant in our field of writing services for industry. So it's it's a mindset, a journey to to to strive to become continually relevant to our clients and in a rapidly changing industry. We believe that relevance is integral to our success because writing services as we know it will be changing. We've already seen the the writing on the wall that margins are getting tighter and smaller and that the work and the budgets for work with our clients are also getting tighter and smaller and our clients are feeling the pinch. dealing with shrinking budgets and having to do more with less. And so we have taken on the challenge this year to find the most efficient processes to become fluent in the technology that is primed to change everything so that we can Find ways to help our clients do more with less. So with your background and your experience and your understanding of this industry and seeing what's changing and looking ahead and seeing what's coming, what for you is the challenge of this year of 2026? Yeah, so the crystal ball. If I'm looking into my crystal ball, I had actually stepped away from being global CEO for about two years. And during that time, I had the opportunity to build these AI writing tools that are our future. Yeah, I'm coming off the heels of the opportunity to build an incredible, you know, AI tool. with, you know, partner in partnership with Moderna and that it's fundamentally different than every tool out there. But it was such an eye opening opportunity to step into that and get to imagine what's possible and really to deep dive and teach myself as much as possible about tech and AI and the different large language models, LLMs that are out there right now. And kind of imagine when understanding their strengths and weaknesses, like how best could they help writers? How best could they add meaningful efficiency, you know, without just moving the same burden upstream or downstream, but actual meaningful efficiency on a company's writing burden. And so I feel very fortunate that I have had that experience and I get to return to my beloved global and our amazing writers, and I get to impart the knowledge that I was able to gain and then just grow from hearing their perspectives. And their perspectives are really fascinating. I mean, I've got people that know way more than I do about technology and have a lot of great ideas. And I've got people that prefer a pencil and paper to technology. And I think everybody's voice in this is valid. Every perspective is valid because they represent, you know, probably opinions that a lot of writers have throughout industry. I mean, talked about how writing is fundamentally our livelihood. And so what a threat AI feels like to us. And instead of just burying our heads or waiting for our future to be decided without our involvement, I see this as an opportunity for us to be a voice and you know, move things in the direction that that would be most helpful to us as because we are the experts doing the work. And it's it's an interesting place to be because my livelihood as a writer, the livelihood of all of my employees is writing and we're being directly challenged by, you know, software solutions that seek to eventually obsolete what we do. And we fundamentally believe that what we bring to the table, our expertise, our our the nuance of understanding and our life experience with negotiating with regulatory agencies, notified bodies, there's a lot of value in that. And that's value that at least in the near term can't be, you know, taught to to AI and so we do carry great value. And so part of our initiative to to seek relevance is that we are. It's called Write the Future. And it's a challenge that we're giving ourselves and anybody who wants to join us to literally play a role in the future of writing and technology and what that means. I want all of our employees to become fluent in tech. They know so well the work streams and best practices and processes of what they do day in and day out. I want to add upon that the understanding of what, you know, current technology out there can and can't do, its strengths and its weaknesses. And then we want to evaluate the different tools that are out there, you know, and not only look for, you know, what we would recommend or want to adopt internally, but hopefully provide feedback to the tech industry on, you know, what writers are looking for, how we work and what in the tools available out there is a good fit. What Isn't and what you know if we were to design the ideal tool, what would that be? And so with the right, the future initiative that we're taking on this year, we're gonna form a committee and this committee will do exactly that. We are going to define some key measures that will help us evaluate the technology. So for instance, we're going to define what does accuracy mean, what is AI accuracy? And we're going to define, you know, how to measure efficiency. And from there, put together a solid evaluation criteria form and then research each tool and and publish its strengths and weaknesses and our candid thoughts, our opinions about what they get wrong and what they get right and what we feel as writers are the best tools and opportunities out there with technology. And so we're excited to take on this challenge this year. If we can become tech fluent, our our ultimate goal is that we can provide free advice that will help tech build tools that are better, stronger, more efficient, more accurate, and that match our needs directly instead of coming to us with, you know, a preconceived, here's a tool, here's what it can do. Now work around it or figure out how to shove this into your process with this and adopt it and just build around it and redo everything. We'd love to provide, very informative, high quality feedback, and we'll do so. So we go through a blog, a blog, a newsletter and some, you know, published white papers. We're excited to basically post throughout the year. And one other thought I had on that with with how important writers are and why they shouldn't be obsoleted or removed from the equation because of the value that we bring. It's interesting, a lot of the tools out there are focused on basically creating prebuilt templates that are cram packed, stuffed with AI prompts and then using curated LLMs like ChatGPT or Claude or Gemini and having it interact with this template and then providing it third piece, which would be. Structured data and that from that it can generate a first draft, which is then turned over to the human. And what's interesting to me is, is that the best way to do this? Usually writers are learning about the data and formulating their assessment and their analysis and conclusions as they are drafting the first draft. And so a first draft done by AI fundamentally changes the relationship writers have with preparing these documents. And so this is just one example of ways that ee can provide our input and suggestions and you know. We think that there there is some value in automating certain sections, but like we need voices out there, we need. people not to be afraid, but to be knowledgeable and to challenge what's out there if we want something better. And it's time to advocate and speak up for ourselves as writers, especially in the regulatory space.
00:13:31 Speaker 1
Yeah, that perspective and approach, being proactive and using your expertise to drive the narrative and the industry forward is such an empowering way to engage with change and innovation. And you have a lot of experience in the regulatory industry, and global has been a strong partner for over a decade. So what are you looking out for in 2026?
00:13:52 Speaker 2
I think the most important thing about 2026 is that we are at the tipping point. We are at the crux. We are at a place where our voices, if we stand up and make them heard, can influence What's being built in terms of these tools that are going to absolutely disrupt how we do things and and our role as writers on these projects. I feel like now is the time. We're not too early and we're not too late. 2027 I think we'd be too late. That's how important 2026 is in in clearly learning everything we can as writers about technology. There's a saying that I've heard many times. You probably have to, and it's that the AI isn't going to steal your job, but somebody who knows how to use AI is going to steal your job. And there's a lot of truth to that. And so like. If you know or at least believe in that basic idea, now is the time to to not fear, but to get as much knowledge as possible and see whatever we can do to influence the the outcome and to be able to demonstrate our value is more than we edit AI first drafts, but that we actually bring a lot more important capabilities to the table. That's yeah. So like I'm really hitting hard on technology and I don't want it to be just technology, but I do feel like that is the pivot point of like writing companies if they want to be relevant. and any kind of regulatory services companies out there that provide writing services that this industry is changing and it's going to start changing even faster. And the best thing we can do for ourselves is help define how our jobs are gonna change and advocate for ourselves. you know, what those tools should be. Sort of our last chance to really step into the ring and be heard.
00:16:41 Speaker 1
Yeah, I really appreciate your, you know, putting medical writers first and having experts really lead the conversation because innovation comes, you know, whether we're ready for it or not. So being thoughtful about that and proactive about that, I think that is really great to see. What other opportunities or thoughts do you have around 2026 for the industry as a whole? Anything else you'd add to the conversation?
00:17:05 Speaker 2
Yeah, I'd like to actually circle back. We started the conversation talking about how everything's changing, the tightening of budgets, the, you know, margin shrinking, the increased costs of labor. all these things that are weighing upon our clients and that relevancy isn't just that you know a lot about technology because that's going to be helpful, I'd say, in 2027, 2028. That is when our ability to provide consulting on the best, you know, adoption Recommendations that we have for specific needs and, you know, change management plans and things like that that will become relevant around that time frame. But there's things we can do right now. There's things that we've already started doing as a company because we feel the pushback when we go into. you know, end of year and and start signing and and formulating the statements of work for the coming year that we are hearing from our clients, you know, we actually have cut budgets. We need to do the same amount of work or even more work for less money, less budget. And that is just the reality period. And one of the things I'm most excited about our group is because we're the best of the best and we know inside and out what our job is and the the process of preparing, you know, everything from a biopharma IND to a medical device CE mark clinical evaluation report. that because of our expertise, we are continually working towards solutions that enable us to do more for less. Like we are dedicated to doing that. And because, you know, technology isn't quite ready to be in that picture, we are doing it by staffing, by team approaches, by clever procedural work instruction, you know, efficiencies. We've already been able to figure out some really neat things that have opened up, you know, larger boluses of work for us because we found a way to do it like 25% cheaper than we we have been doing it in the last few years and that that is our goal and our promise to clients that we're not waiting for tomorrow, but we have the answers today and that we can work with volume and find very clever ways to still deliver the same caliber caliber of accuracy and quality that we are known for, but having clever approaches that allow us to do more with less. And so I'm excited for this year. I think relevancy is going to mean doing more with less. Relevance is going to have to do with becoming technology fluent. And that ultimately, as we grow in each capacity, we will begin to, you know, partner them together and and really provide the most effective solutions for industry for for the next decade. So we're looking forward to that.
00:21:18 Speaker 1
Sounds like it's a very exciting year. Lots of changes and opportunities and challenges along the way. And I think with, like you said, our team of experts and very dedicated medical writers and with your vision and excitement for what's coming, I think our clients are going to be very happy with what we deliver and lots of creative solutions to make things work in our favor. So thank you for being here and sharing that with us.
00:21:42 Speaker 2
Thank you. Appreciate the time.
00:21:46 Speaker 1
Thank you so much for listening to this episode of Chasing Compliance, and thank you again to Em for joining us. If you're interested in learning more about how Global can support your regulatory writing and consulting needs, please visit at www..globalrwc.com or e-mail us at info at globalrwc.com. If you liked today's episode, please share it and leave a review. And until next time, we wish you continued compliance.
