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Associate / Sr Associate - Regulatory Labeling

1 month ago

Indiana, United States Eli Lilly Full time

Associate / Sr Associate - Regulatory Labeling page is loaded Associate / Sr Associate - Regulatory Labeling Apply locations Ireland, Cork time type Full time posted on Posted 2 Days Ago job requisition id R-60957 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 At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challeng Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Lilly 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. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself The purpose of the Labeling Associaterole in the Global Labeling Department at Cork is to lead the development and maintenance of Core labeling documents and provide oversight of global implementation for drug and combination device products. The Associate leads the development of United States (US) and Canada packaging and combination device patient labeling. The Associate serves as the primary interface with the Printing Packaging Development (PPD) organization for implementation of US and Canada labeling. The Associate drives consistency in labeling processes and operations. Primary Responsibilities: 1. Core Labeling Development and Maintenance Lead the development and maintenance of Core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content]. Lead the preparation activities and facilitate approval of Core labeling by the Global Product Labeling Committee for CDS and CDL and Global Labeling Council for CMC CLC. Communicate initial and revised Core labeling to global affiliates and provide support and consultation, as necessary. 2. US and Canada Labeling Development and Maintenance Lead the development and maintenance of US and Canada packaging for Lilly drug and combination device products. Lead the development and maintenance of US and Canada combination product patient labeling [i.e., Instructions for Use (IFU) and Quick Reference Guide (QRG)]. Serve as primary liaison with the Device Delivery & Connected Solutions (DDCS) organization. Lead the development and maintenance of Clinical Trial IFUs. Demonstrate in-depth understanding of content, format, and style requirements for labeling documents including local regulations, guidance, and trends. Conduct data integrity reviews of healthcare provider labeling in partnership with GRA-NA Clinical Regulatory. Serve as primary liaison with PPD organization for implementation of US and Canada labeling. Serve as primary liaison with DDCS and PPD organizations for development of labeling artwork. Communicate initial and revised US and Canada labeling to global affiliates and provide support and consultation, as necessary. Lead labeling contributions for periodic reporting (e.g., FDA Annual Report, Periodic Safety Update Report, Periodic Benefit/Risk Evaluation Report, Development Safety Update Report) in collaboration with GRA-NA Clinical Regulatory. Coordinate the translation of labeling documents with vendors. 3. Labeling Expertise and Process Excellence Provide Regulatory input and guidance on Core labeling and US and Canada labeling specific to packaging and IFUs. Manage Core labeling exception requests from affiliates and facilitate approval from leadership. Perform periodic labeling assessments to assess compliance of affiliate product information with 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. Maintain the end-to-end labeling system for Core, US, and Canada labeling. Develop, update, maintain, and archive labeling documents utilizing appropriate tools, systems, and version control. Plan, track, and record labeling submission and approval activities using the appropriate tools and systems. 4. 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. Collaborate effectively with business partners and stakeholders. Minimum Qualification Requirements: Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience). Knowledge of the drug development process. Additional Preferences / Other Information: Regulatory experience. Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory reform initiatives related to combination products. Ability to apply therapeutic expertise. Project Management experience. Demonstrated ability to lead, influence and partner. Demonstrated communication skills: writing, presenting, listening. Demonstrated effective teamwork skills; ability to adapt to diverse interpersonal styles and working across geographies. Demonstrated attention to detail and organizational skills. Ability to learn and use new software/technology. Ability to manage strategic and operational tasks. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lillydoes 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 About Us At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe #J-18808-Ljbffr