Associate Label Management

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $140,800

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

Basic Qualifications:

Educational Requirements: Four-year degree, preferably in a pharmacy, health-related, scientific, or engineering field or equivalent work experience.

 

Experience Preferred:

A successful employee in this role would possess:

• Minimum 3 years' experience in Clinical Supply and Delivery or related clinical or Regulatory role

• Ability to translate study protocol elements and packaging design into a clearly defined plan for label text