Functionally Speaking Series: Regulatory Intelligence, Medical Writing and the AI Inflection Point

In this episode, Lynn Hamilton speaks with Stuart Goodall, Senior Vice President at Syneos Health, about how regulatory functions are evolving in response to growing complexity, accelerating timelines and emerging technologies. With more than 35 years of global experience, Stuart offers an unfiltered perspective on what regulatory and medical writing teams need to succeed today—and how to scale smartly for what’s next.

Topics explored include:

·      The shift from information advantage to decision advantage in regulatory intelligence

·      How AI is changing—not replacing—medical writing and regulatory operations

·      What sponsors need to consider when building scalable, tech-enabled models

·      Why FSP is no longer just transactional and how strategic partnerships are redefining value

·      Why storytelling and judgment remain irreplaceable in an automated world

Whether you're exploring your next medical writing solution or rethinking regulatory infrastructure, this conversation offers grounded insights with a forward-looking lens.

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you’ll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub.

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We want to hear from you! If there’s a topic you’d like us to cover on a future episode, contact us at podcast@syneoshealth.com.