Shawn (Liz) Lucini
Senior Director - Regulatory Affairs
Noven Pharmaceuticals 

Miami, FL

“My family positively influenced my life and career by instilling a strong work ethic. My grandfather worked in a steel mill helping support 12 younger siblings; my grandmother worked long hours as a nurse while raising a family, and my mother exemplified determination by pursing a master’s degree, working and raising children.”

Liz has led Noven to multiple successes during her tenure.  Through her skills and leadership, Noven accomplished first-cycle approval of a new non-hormonal therapy, which required strategic labeling negotiations, rigorous Advisory Committee preparations, timely NDA preparations and filing, and leading Noven’s pre-NDA meeting. Additionally, her oversight and guidance for the Minivelle® NDA filing on very tight timelines allowed first-cycle approval of the NDA. 

Liz routinely provides review of promotional pieces for regulatory compliance and participates in strategic discussions.  She is on several committees with broad company impact, including: the Product Portfolio Committee, the Product Selection & Enhancement Committee, the Events Oversight Committee, the Commercial Compliance Committee, the Grants Committee, and the Joint Steering Committee for partnered products.

She credits her work at Roche on multiple FDA meetings for Tamiflu during the H1N1 pandemic for developing critical skills she relies on for success at Noven. Among these skills, her tenacity, integrity, hard work and strategic thinking resulted in the approval of exceptional new drugs.

In 2012, Liz won Noven’s Platinum Award for her outstanding contributions leading to the timely submission of Noven’s NDA for Minivelle.   This award recognizes colleagues for sustained extraordinary performance, the successful completion of key projects and exceptional improvements to Noven’s internal processes while demonstrating on a daily basis adherence to Noven’s Core Values.  She is an exceptional leader within the organization.

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