• Authors (user friendly, international language, consistent across products) and maintains core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide • Chairs/leads the Labeling Working Group, and presents to Executive Labeling Board • Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends • Advises internal and/or external specialists on the creation of high quality documents supporting changes to the core labeling documents and runs the annotations within those documents • Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies. • Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies • Represents labeling on product-specific global regulatory teams