Labeling Implementation Associate - North America (P1-3)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose

The Associate/Sr. Associate/Manager/Sr. Manager, Global Regulatory Affairs (GRA) Labeling Implementation drives the timely and high-quality implementation and maintenance of product labeling in the assigned country/region.  The Associate/Sr. Associate/Manager/Sr. Manager develops collegial, mutually productive relationships across Regulatory, Printed Packaging Development (PPD), Manufacturing / Supply Chain, Global Packaging, Development, and other business partners.  The Associate/Sr. Associate/Manager/Sr. Manager utilizes regulatory labeling process expertise across the organization and geographies to drive consistency and influence effective change management. 

Primary Responsibilities

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. 

• Act as a delegate for Affiliate labeling implementation responsibilities outlined in the Labeling Development and Maintenance standard. 

• Support Affiliate Labeling Responsible Person (ALRP) in submission and implementation activities related to the Artwork Request Form (ARF) process and printed sample requests. 

• Lead and monitor the implementation of updated or new labeling components into the market. 

• Execute the ARF process and liaise with affiliates and PPD groups to ensure timely implementation of new or revised labeling. 

• Advise affiliates on responsibility for managing control and integrity of affiliate truth copy documents. 

• Liaise with cross functional partners to manage 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. 

• Support ALRPs with their tracking and planning activities for labeling in RIM.  

• 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. 

• Lead, partner, and influence labeling-related activities throughout the product lifecycle, including communication with affiliates for submission activities related to the ARF process and samples and implementation of local labeling.  Understand and communicate manufacturing impact (cost and resources) associated with labeling changes. 

• Share timely information with other labeling colleagues to capitalize on best practices. 

• Act as a subject matter expert 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 

• Recognize complex labeling scenarios and identify potential solutions.  Escalate when necessary. 

• 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 with cross functional partners to enable effective decision making and timely completion of deliverables. 

• Develop best practices for metrics collection and reporting. 

Impact 

• Drive timely implementation of labeling changes ensuring regulatory and internal timelines are met. 

• Demonstrate understanding of labeling implementation process and determine impact.  Communicate impact of labeling changes to cross-functional partners. 

• Collaborate with Regulatory team on submission and implementation plans to capitalize upon opportunities for bundling changes for more efficient implementation, when applicable. 

Customer / External Focus 

• Routinely share labeling knowledge with key customers.  Participate in internal working groups to make recommendations that may shape regulatory labeling environment. 

• Collaborate with Regulatory team regarding labeling strategic plans/issues. 

• Establish relationships with customers and partners.  Drive to mutually agreeable solutions.  Seek input and advice from peers and management. 

• Identify appropriate customers and partners to communicate impact of labeling changes.  Anticipate questions and proactively communicate potential impact to labeling. 

Minimum Qualification Requirements

• Bachelor’s degree

Other Information/Additional Preferences

• 3-5 years in the biotechnology or pharmaceutical industry

• Scientific or health sciences degree discipline preferred (or equivalent work experience) 

• Knowledge of local regulatory procedures and practices and awareness of evolving regulatory reform  

• Understanding of manufacturing and supply chain practices 

• Knowledge of drug development  

• Project management experience 

• Demonstrated ability to lead, influence and partner cross-functionally 

• Demonstrated capability for contributing on complex projects with aggressive timelines 

• Demonstrated strong communication skills: writing, presenting, listening. 

• Proven flexibility to manage multiple tasks simultaneously 

• Demonstrated competence of computer skills (e.g., Word, Excel, PowerPoint) 

• Demonstrated agility to learn new computer systems and tools 

• Demonstrated attention to detail and organizational skills 

• Demonstrated ability to work independently 

• Demonstrated effective teamwork skill and able to adapt to diverse interpersonal styles 

• Demonstrated problem solving skills 

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