Global Regulatory Affairs

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.

Overview:

The purpose of the Spanish-Multi Market Labeling Coordinator is to:

Support labeling development carried out by external partners who hold local product licenses for Lilly manufactured products in Latin America, where Spanish Multi Market Labelling (SP-MML) is used. This role also prepares and provides Affiliates and external partners with timely and complete regulatory submission packages to support both new and revised MML, ensuring alignment with Reference Country labelling and meeting internal as well as external expectations. The Coordinator serves as a central point of coordination and communication with global and cross-functional teams, and may also support country-specific packaging development in place of an affiliate ALRP when requested. In fulfilling these responsibilities, the Coordinator drives the timely submission and implementation of labeling changes to ensure that both regulatory and internal timelines are met, demonstrates a thorough understanding of the labeling implementation process and its impact, communicates the implications of labeling changes to cross-functional partners, and develops submission and implementation plans that capitalize on opportunities to bundle changes for more efficient execution when appropriate.

Responsibilities:

Key Tasks:

• Serve as a labelling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labelling for new and marketed products.
• Support labeling development executed by external partners holding local product licenses of Lilly manufactured products on their own behalf.
• 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 ARF and Truth/Proof Process including any needed translations to create new and updated MMLs and provide required submission documents to affiliate ALRPs and/or External Partner.
• 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.
• Monitor reference country product labels for planned implementation in MML.
• 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 Veeva Vault RIM entries when needed for each impacted market for planning, tracking and status reporting purposes and ensure that data in Veeva Vault RIM and BLUE 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 and external partner training including the use of Veeva Vault RIM and BLUE to ensure accurate data capture.
• Process information and team/audience dynamics and adapt style when negotiating with cross functional partners to enable effective decision-making and timely completion of deliverables.
• As required, as delegate ALRP, perform tasks related to country-specific labelling in collaboration with the Regional Labelling Coordinator.
• Support and collaborate with other Labeling Coordinators as capacity allows.
• Utilize regulatory labeling and process expertise to drive consistency and influence effective change management for labeling processes optimization.
• Other GRA regulatory initiatives

Functional and Technical Expertise

• Develop, improve, and maintain tools to retain labeling information.
• 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 Coordinators to capitalize on best practices.
• Educate affiliates and external partner, when necessary, on regulatory requirements, roles, and responsibilities, labeling best practices and the process to ensure high quality translations and timely implementation of new or revised labeling.

Basic Requirements:

• Education Requirements: Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
• Fluent (speaking and reading/writing) in Spanish and English
• Demonstrated attention to detail.
• Demonstrated ability to multitask, plan, prioritize and project manage.
• Demonstrated computer skills (Word, Excel, Power Point)
• Ability to work independently
• Good communication skills
• Demonstrated agility to learn new IT systems/tools.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
• Demonstrated ability to work independently.
• Demonstrated problem solving skills.

Additional Skills/Preferences:

• Understanding and knowledge of medicines.
• Previous coordinator role or Project management experience.
• Understanding and knowledge of the emerging market environment and regulations
• Regulatory experience in an affiliate office
• Use of databases relevant to regulatory business.

Additional Information:

• This role may be located in Argentina, Brazil, Colombia, Costa Rica, Mexico or Peru.

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