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 39,000 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.
As a Label Management Associate, you will leverages technical expertise to consistently and accurately create Investigational Medicinal Product (IMP) label text that meets the needs of a given study and is compliant with all applicable regulatory requirements. You will be responsible for providing input into supply planning activities through interaction and communication with other Product Delivery (PD) teams, creating label text, submitting label requests, and reviewing label proofs produced by external vendors. You will be accountable for following all applicable quality and regulatory requirements in order to consistently and accurately deliver IMP labels on-time and with quality. Additionally, you will effectively collaborate with internal/external partners to provide compliant labels, on-time, for clinical trials and provide solutions to optimize the PD master label creation and approval process. Other activities in this role include:
Create and submit label requests for all PD-provided labels
Create label text for all labels provided by PD
Develop and maintain technical expertise regarding regulatory requirements for IMP label text
Develop and maintain consistency and standardization in the IMP labels provided by PD
Collaborate and communicate with Demand Forecasting Consultants (DFCs), Molecule Planners (MPs), and Clinical Supply Coordinators (CSCs)
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
Provide label expertise to, and coordinate the flow of information with, multiple internal and external partners, including DFCs, MPs, CSCs, Label Project Coordinators, Data Stewards, Packaging Operations, Clinical Development Organization, third parties, global affiliates, Quality Assurance, 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
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
Masters in Science or PharmD degree
Minimum 1 year experience in product delivery or related clinical role
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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.
French fluency highly desired
Must speak fluent English
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
Lilly is an EEO/Affirmative Action Employer and 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.