Nicole Buzin, PhD
About Nicole Buzin, PhD
Nicole Buzin, PhD, is the Director (Head) of Global Regulatory Writing at BeiGene and Associate Director of Medical Writing at Moderna, with extensive experience in clinical and regulatory writing across various therapeutic areas.
Company
Nicole Buzin, PhD, currently holds prominent positions at both BeiGene and Moderna. At BeiGene, she serves as the Director (Head) of Global Regulatory Writing, responsible for leading and overseeing regulatory writing activities on a global scale. Additionally, she works at Moderna as the Associate Director of Medical Writing in Cambridge, Massachusetts, focusing on creating high-quality clinical documentation to support regulatory submissions and product development.
Title
Nicole Buzin, PhD, is the Director (Head) of Global Regulatory Writing at BeiGene and an Associate Director of Medical Writing at Moderna. Her roles involve managing and producing regulatory and medical documentation that adheres to global standards and supports the development and approval of new medical products.
Education and Expertise
Nicole Buzin holds a PhD in Neuroscience from UT Southwestern Medical Center, where she studied from 2007 to 2014. She also earned a Bachelor of Arts (BA) in Psychology and Criminal Justice from the University of Delaware, studying there from 2001 to 2005. Nicole has an extensive background in creating clinical and nonclinical content for global regulatory submissions and specializes in strategic communications deliverables to support new product development worldwide.
Professional Background
Nicole has a diverse and robust professional background, having worked with several leading pharmaceutical companies. At EMD Serono, Inc., she was a Sr Principal Medical Writer from 2019 to 2020. She served as an Associate Principal Medical Communications Scientist at AstraZeneca from 2016 to 2019. Her earlier roles include Senior Medical Writer at ARIAD Pharmaceuticals, Inc., and Pharmacology Scientist/Medical Writer at Indivior. Nicole has experience working as a Scientific Writer at PPD and held academic positions such as Graduate Student at UT Southwestern Medical Center at Dallas and Research Assistant at the University of Delaware.
Specialized Skills and Leadership
Nicole has extensive experience in preparing high-quality clinical and nonclinical content for major global regulatory submissions, including IND/IMPD and NDA/MAA/JNDA/BLA. She specializes in submission communication strategies like storyboards and message maps, supporting global product development. Her expertise spans multiple therapeutic areas, including neuroscience, oncology, metabolic disease, respiratory, and infectious diseases. Nicole's leadership skills are demonstrated through her ability to build trust, motivate teams, and make decisive moves in ambiguous situations, focusing on innovation and execution. She has a proven track record of developing processes, driving initiatives, and optimizing best practices in clinical and regulatory writing.