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Associate Director
1 week ago
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 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.
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.
In-house 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, Age & Culture, LGBTQ+ 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
Purpose: The purpose of the Associate Director/Director, Global Regulatory Affairs (GRA) Global Core Labeling (P4/P4-2) role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.
The Associate Director/Director ensures timely delivery of global labeling to Lilly affiliates to facilitate simultaneous global submissions.
Additionally, the Associate Director/Director leads timely updates and communication of core labeling changes throughout the product lifecycle.
Primary Responsibilities: Global Labeling Leadership Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions.Implement "Accelerate Reach and Scale" initiatives related to global labeling strategy.Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.Core Labeling Development and Maintenance Lead the development and maintenance of core labeling (i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content).Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC).Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.Lead the development and maintenance of clinical trial Instructions for Use.Labeling Process Excellence Optimize core labeling exception process.
Manage core labeling exception requests and facilitate approval from leadership.Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.Serve as subject matter expert for core labeling.
Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes.Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.Develop and present metrics to governance and other forums to monitor and improve the labeling exception process.Lead/Influence/Partner Exemplify the Team Lilly behaviors of Include, Innovate, Accelerate, and Deliver.Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy.Ensure timely communication of global labeling to global affiliates.Partner with Labeling Implementation Associates to ensure local labeling aligns with core labeling.Minimum Qualification Requirements: Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.Demonstrated knowledge of the drug development process and Lilly regulatory/business strategies.Demonstrated ability to assess and manage risk in a highly regulatory environment.Demonstrated ability to lead, influence and partner cross-functionally.Demonstrated strong communication skills: writing, presenting, listening.Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.Demonstrated attention to detail and organizational skills.Ability to learn and use new software/technology.Ability to manage multiple tasks simultaneously.Other Information/Additional Preferences: Knowledge of procedures and practices related to drug and device labeling and awareness of evolving global regulatory reform initiatives.Ability to apply therapeutic expertise.Project management experience.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 ) 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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