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:
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.
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.
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!
Main Purpose and Objectives of Position:
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.
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
deliver Investigational Product (IP) labels on-time and with quality.
Key Responsibilities:
Create and submit label requests for all labels provided by Clinical Supply and Delivery
• Create label text for all labels provided by Clinical Supply and Delivery
• Develop and maintain technical expertise regarding regulatory requirements for IP label text
• Develop and maintain consistency and standardization in the IP labels provided by Clinical
Supply and Delivery
• Collaborate and communicate with Supply Planning partners
• Review protocols, packaging designs, and order forecasts to ensure label text is accurate and
consistent with study and packaging designs
• Submit, track, and ensure timely completion of label requests to meet packaging order start timelines
Effectively collaborate with internal/external partners to provide compliant labels, on-time, for clinical trials
• 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)
• Identify and execute on opportunities to improve label strategies by accelerating the timeline, reducing costs, and minimizing risks
• Prevent issues through planning and customer education. Proactively identify and resolve issues as required.
• Proactively propose new phrases for addition to Lilly’s label phrase library
• Create and provide labels to affiliates and third parties for global regulatory submissions
Provide solutions to optimize the Clinical Supply and Delivery master label creation and approval process
• Proactively identify ways to improve day-to-day activities and practices and actively communicate the opportunities to process owner(s) and leadership
• Participate in and/or support the implementation of process improvement initiatives related to the label process
• Stay abreast of cGMPs, GCPs, and other regulatory requirements related to the label process, and ensure activities stay in alignment with all regulations
Additional responsibilities may include:
• Identifying root causes when issues occur and develop, recommend, communicate and implement corrective actions and lessons learned
• Effective planning for upcoming work and communication to other groups as needed
• Collecting and reporting metrics
• Coaching and mentoring of other less senior Label Management Associates
• Involvement with special projects and periodic reviews
•Subject Matter Expertise in Compound Models and/or other areas
Educational Requirements:
Four-year degree, preferably in a pharmacy, health-related, scientific, or engineering field or equivalent work experience.Additional Requirements:
A successful employee in this role would possess:
• Minimum 3 years experience in Clinical Supply and Delivery or related clinical role
• Ability to translate study protocol elements and packaging design into a clearly defined plan for label text
• Strong record of performance
• Demonstrated effectiveness in influencing across teams, management levels, and ability to work collaboratively
• Strong written and verbal communication skills
• Demonstrated effectiveness performing tasks requiring a strong attention to detail
• Strong interpersonal skills, including capability to engage in professional relationship building and networking
• Solid working knowledge of GCP regulations and GMP requirements
• Strong proficiency with computer applications including Microsoft Office products
Knowledge and experience working with Quality Assurance in a highly regulated area and relevant external experience, preferably within the industry, are highly beneficial.
License/Certificate Requirements: None (Pharmacist preferred)
Language Requirements: Must speak fluent English.
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.
#WeAreLilly