Associate/Sr. Associate/Manager/Sr. Manager, GRA Global Labeling Cork, Labeling Operations Lead

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.

About Lilly

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. 

Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Role Overview:

The purpose of the Associate/Sr. Associate/Manager/Sr. Manager, GRA Global Labeling Cork, Labeling Operations Lead (P1-3/3-2) role is to serve 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 fora, and the broader Global Labeling Organization.

In addition, the role serves as Multi-Market Labelling Coordinator for International Affiliates and external partners using MML. It prepares and delivers timely, complete regulatory submission packages aligned with Reference Country labelling, supporting new and revised MML in line with internal and external expectations.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Labeling Operations, Process & Business SME Ownership

Serve as process owner and business subject matter expert for the Artwork Request process, including Artwork Request Form (ARF) Monitor support, and partnership with the Artwork Management Process Owner. Own the Implementation Timing extension process and approve extension requests; support related governance oversight activities. Manage the Affiliate Labeling Responsible Person (ALRP) directory, the related content repository, and the end-to-end ALRP registration process; own the related directories for other labeling roles, such as Regional Labeling Coordinator (RLC) and Multi Market Labeling Coordinator (MMLc). Own the External Labeling Partner process, approve access requests, and maintain the partner roster. Execute and present Labeling Submission & Implementation metrics, and support the development and presentation of these metrics to governance forums. Serve as business subject matter expert for the integration of internal data hubs with RIM (Regulatory Information Management), and the AMS (Artwork Management System), covering issue detection, escalation, and change-control. Own RIM labeling reports and the Submission & Implementation metrics dashboards, and act as consultant on the broader Labeling Dashboard. Own the Health Authority Implementation Requirements process and the supporting reference workspace. Support Learning & Development through ownership of the ALRP curricula and key computer-based training. Act as primary business subject matter expert for Quality Documents and the associated Required Tools, such as ALRP registration, AMS guide & usage, Truth Copy (TC) preparation, Implementing Labeling, ARF, Country Implementation Requirements.

Multi-Market Labelling (MML) Coordination

Act as a delegate for Affiliate labelling responsible person (ALRP) outlined in the Labelling Development and Maintenance standard. Liaise closely with GRA Regional Regulatory Scientists and Manufacturing/supply chain on the creation of new MML to support product launch. Manage Artwork Request and Truth/Proof Process including any needed translations to create new and updated MMLs and provide required submission documents to affiliate ALRPs. Drive the maintenance of marketed product MML in line with reference label, internal timelines and bundling decisions. Monitor, support and drive the implementation of updated or new labelling components into the market. Maintain the MML strategic plan and monitor reference country product labels for planned implementation in MML. Ensure Veeva Vault RIM (Regulatory Information Management) and AMS (Artwork Management System) data accuracy across impacted markets. Maintain up-to-date knowledge of submission statuses, requirements, and conditions of MML markets. Network with global manufacturing site functions such as Supply Chain, Manufacturing, Regulatory and Printing, Packaging and Development to develop labelling materials, acquire submission documents and plan and manage MML production decisions. Create RIM entries when needed for each impacted market for planning, tracking and status reporting purposes and ensure that data in RIM and the AMS are accurate at all times. Recognize complex labelling scenarios that require solutions. Identify potential solutions. Escalate when necessary. Apply knowledge of business processes and labelling to gain alignment with partners on standardized processes and labelling deliverables. Provide ALRP training including on the use of RIM and the AMS to ensure accurate data capture. As required, as delegate ALRP, perform tasks related to country-specific labelling. Support labeling development executed by external partners holding local product licenses of Lilly manufactured products on their own behalf.

Exemplify the Team Lilly behaviors of 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.

#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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