Associate - Labeling Implementation - North America

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Organization Overview At Lilly, we serve an extraordinary purpose.   We make a difference for people   around the glob e   by discovering,   developing   and delivering medicines that help   them   live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Purpose The Associate - Global Regulatory Affairs (GRA) Labeling Implementation -North America drives the timely and high-quality implementation and maintenance of product labeling in the assigned country/region. This role develops collegial, mutually positive relationships across Regulatory, Printed Packaging Development (PPD), Manufacturing/Supply Chain, Global Packaging, Development, and other business partners. The Global Regulatory Affairs (GRA) Labeling Implementation utilizes regulatory labeling process expertise across the organ ization and geographies to drive consistency and influence effective change management.

Labeling Implementation Leadership     Lead, partner, and influence labeling-related activities throughout the product lifecycle to drive timely and efficient implementation of labeling changes ensuring regulator and internal timelines are met.    Function as a delegate for Affiliate labeling implementation responsibilities outlined in the Labeling Development and Maintenance standard.    Lead and monitor the implementation of updated or new labeling components into the market.    Advise affiliates on responsibility for managing control and integrity of affiliate truth copy documents.    Liaise with cross functional partners to handle multiple changes occurring simultaneously (e.g., GRA-CMC or site technical changes impacting labeling).    Provide oversight for the proof copy approval process and interactions with PPD.    Train and assist affiliates on the use of systems, tools, and processes.    Act as a power user for key labeling systems such as BLUE, RIM, etc.    Assist with deviations, escalations, and audits related to labeling implementation.    Monitor new regulations and guidances for assigned country/region, assess impact with input from Regional Regulatory Scientists, Device Regulatory Scientists, and Labeling Process Owner, and track progress.    Functional and Technical Expertise     Maintain an understanding and expertise on local requirements, laws, and regulations related to labeling implementation.    Act as a subject matter authority and resource for other GRA colleagues (e.g., Regional Regulatory Scientists, Device Regulatory Scientists, Product Communication reviewers) on labeling processes.    Educate customers on regulatory requirements, roles / responsibilities, labeling best practices and the process to ensure timely implementation of new or revised labeling.    Decision Making/Influence/Problem Solving     Serve as a labeling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labeling for marketed products.    Apply knowledge of business processes and labeling to gain alignment with partners on standardized processes and labeling deliverables.    Process information and team dynamics and adapt a style when negotiating