Associate - Labeling Implementation - North America

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.  

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

Impact  

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

• Demonstrate understanding of labeling implementation process and understand 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.  

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

Basic Qualifications

• Bachelor’s degree  

• 2 + years in the biotechnology, device, or pharmaceutical industry

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences/Other Information 

• Scientific or health sciences degree field 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 accelerated timelines  

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

• Shown flexibility to handle multiple tasks simultaneously  

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

• Demonstrated agility to learn new computer systems and tools, attention to detail and organizational skills, and ability to work independently  

• Demonstrated effective teamwork abilities, adaptability to diverse interpersonal styles, and problem-solving skills