Overview
Role: Associate/Sr. Associate/Manager/Sr. Manager, GRA Global Labeling Cork, Labeling Operations Lead. The role serves as process owner and business subject matter expert for a defined portfolio of global labeling operational processes, business systems, metrics, and required tools, supporting affiliates, governance forums, and the broader Global Labeling Organization. It also acts as Multi-Market Labelling Coordinator for International Affiliates and external partners using MML, preparing and delivering regulatory submission packages aligned with Reference Country labelling and supporting new and revised MML in line with internal and external expectations.
Responsibilities
Labeling Operations, Process & Business SME Ownership: act as process owner and SME for the Artwork Request process (ART/ARF), monitor support, collaborate with the Artwork Management Process Owner, own the Implementation Timing extension process and approve extension requests; support governance oversight activities.
Manage the Affiliate Labeling Responsible Person (ALRP) directory, related content repository, and end-to-end ALRP registration; own directories for Regional Labeling Coordinator (RLC) and Multi Market Labeling Coordinator (MMLc).
Own the External Labeling Partner process, approve access requests, maintain the partner roster; execute and present Labeling Submission & Implementation metrics; support development/presentation of metrics to governance forums.
Serve as SME for integration of internal data hubs with RIM (Regulatory Information Management) and AMS (Artwork Management System); cover issue detection, escalation, and change control.
Own RIM labeling reports and the Submission & Implementation metrics dashboards; act as consultant on the broader Labeling Dashboard; own the Health Authority Implementation Requirements process and supporting reference workspace.
Support Learning & Development through ownership of the ALRP curricula and key computer-based training; act as primary SME for Quality Documents and related tools (ALRP registration, AMS guide & usage, Truth Copy preparation, Implementing Labeling, ARF, Country Implementation Requirements).
Multi-Market Labelling (MML) Coordination: act as a delegate for Affiliate labeling responsible person (ALRP); liaise with GRA Regional Regulatory Scientists and Manufacturing/Supply Chain for new MML creation to support product launches; manage Artwork Request and Truth/Proof processes including translations to create new/updated MMLs; provide submission documents to affiliate ALRPs.
Maintain MML in line with reference labels, internal timelines, and bundling decisions; monitor, support, and drive implementation of updated or new labeling components into markets.
Maintain the MML strategic plan and monitor reference country product labels for planned MML implementation; ensure data accuracy in Veeva Vault RIM and AMS across impacted markets.
Keep up-to-date knowledge of submission statuses, requirements, and conditions of MML markets; collaborate with global manufacturing site functions to develop labeling materials, acquire submission documents, and plan MML production decisions.
Create RIM entries for impacted markets as needed for planning, tracking, and status reporting; ensure data accuracy in RIM and AMS; recognize complex labeling scenarios and escalate when necessary.
Apply knowledge of business processes and labeling to align with partners on standardized labeling deliverables; provide ALRP training on the use of RIM and AMS; perform country-specific labeling tasks as delegated and support labeling development by external partners with local licenses.
Demonstrate the Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
Minimum Qualification Requirements
Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience).
Working knowledge of labeling business systems (e.g., RIM, AMS / artwork management, dashboard / reporting tools).
Fluent (speaking and reading/writing) in relevant MML language.
Strong communication, planning, and stakeholder-management skills; ability to work independently and cross-functionally.
Proven ability to manage multiple priorities and deliver against ambitious timelines.
Computer skills (Word, Excel, PowerPoint, SharePoint).
Other Information / Additional Preferences
3–5 years of experience in Regulatory, Labeling, Quality, or drug development.
Comfort working with system reports and data, with a proactive interest in understanding the data model behind them.
Interest in implementing, adopting, and using new technologies, including automation and AI, to improve labeling operations and ways of working.
Experience working with affiliates in international settings and interpretation/application of global policies and procedures.
Experience working with business support systems, IT support teams, and vendor system enhancement requests.
Knowledge of evolving regulatory and labeling implementation requirements.
Use of databases relevant to regulatory business.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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