Associate / Sr Associate – Regulatory Labeling
Eli Lilly
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 LillyAt 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 challengEli 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 of Business 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 Associate role 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
2. US and Canada Labeling Development and Maintenance
3. Labeling Expertise and Process Excellence
4. Lead/Influence/Partner
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.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
Cork
Sat, 24 Feb 2024 23:45:08 GMT
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