Associate / Sr. Associate - Clinical Trial Label Management

<p>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.</p><p></p><p><b>Overview:</b></p><p>At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in, in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. </p><p></p><p>Eli Lilly Cork is made up of a talented diverse team of over 1,600 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. 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.</p><p></p><p>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 &amp; 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.</p><p>Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!</p><p></p><p><b>Main Purpose and Objectives of Position:</b></p><p>The Label Management Associate leverages technical expertise to consistently and accurately create investigational product label text that meets the needs of a given study and is compliant with all applicable regulatory requirements.</p><p>The Label Management Associate is responsible for providing input into supply planning activities through interaction and communication with other Clinical Supply and Delivery teams, creating label text, submitting label requests, and reviewing label proofs produced by external vendors. The Label Management Associate is also accountable for following all applicable quality and regulatory requirements in order to consistently and accurately</p><p>deliver Investigational Product (IP) labels on-time and with quality.</p><p></p><p><b>Key Responsibilities:</b></p><p>Create and submit label requests for all labels provided by Clinical Supply and Delivery</p><p>• Create label text for all labels provided by Clinical Supply and Delivery</p><p>• Develop and maintain technical expertise regarding regulatory requirements for IP label text</p><p>• Develop and maintain consistency and standardization in the IP labels provided by Clinical</p><p></p><p>Supply and Delivery</p><p>• Collaborate and communicate with Supply Planning partners</p><p>• Review protocols, packaging designs, and order forecasts to ensure label text is accurate and</p><p>consistent with study and packaging designs</p><p>• Submit, track, and ensure timely completion of label requests to meet packaging order start timelines</p><p></p><p>Effectively collaborate with internal/external partners to provide compliant labels, on-time, for clinical trials</p><p>• Provide label expertise to, and coordinate the flow of information with multiple internal and external partners, including Supply Planning, Label Project Coordinators, Local Data Analysts, Packaging Operations, Clinical Development Organization, third parties, global affiliates, Quality, and ELECTS (Eli Lilly European CT Services)</p><p>• Identify and execute on opportunities to improve label strategies by accelerating the timeline, reducing costs, and minimiz