Associate - Labeling Implementation - North America

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree
• 3-5 years in the biotechnology 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 and 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

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level