Lilly Associate-Label Management-FDE in Indianapolis, Indiana
Type of Employment:
Fixed Duration Employment – FDE
The Clinical Trial Supply Planning team is responsible for providing Investigational Product (study drug) management services for global clinical trials in all development phases, including partnering with medical teams to develop compound and study supply plans, package design, label creation, and other deliverables required to initiate a Clinical Trial Material Request. The CTSP team also provides oversight of business processes related to on time study drug delivery at clinical trial sites.
The Label Management Associate leverages technical expertise to consistently and accurately create investigational product label text that meets the needs of the 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 Clinical Trial Material Management and Services (CTMMS) teams, creating label text, submitting the label request, and reviewing label proofs provided 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 IP labels on-time and with quality.
Create and submit label requests for all CTMMS-provided labels
Create label text for all labels provided by CTMMS
Develop and maintain technical expertise regarding regulatory requirements for IP label text
Develop and maintain consistency and standardization in the IP labels provided by CTMMS
Collaborate and communicate with Clinical Trial Supply Planning (CTSP) associates
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 TCOE and external partners, including Clintrak Label Coordinators, CTSP Associates, Outsourcing group, Clinical Development Organization, third parties, global affiliates, Japan-CTSC’s, Quality, and ELECTS
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 implementation of the CTMMS master label 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 local or divisional six sigma or other 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 all regulations
Identify root causes when issues occur and develop, recommend, communicate and implement corrective actions and lessons learned
Effectively plan for upcoming work and communicate to other groups (e.g., outsourcing, ELECTS), as needed
Collecting and reporting metrics
Coaching and mentoring of other less senior Label Management Associates
Bachelor's degree OR Associate degree and 5+ years of healthcare/pharmaceutical experience.
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
3 years experience in a Clinical Trial Material Manufacturing and Services 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
Solid working knowledge of GCP regulations and GMP requirements
Strong proficiency with computer applications including Microsoft Office products
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
Must be fluent in English
Knowledge and experience working with QC in highly regulated area and relevant external experience, preferably within the industry
This position is a fixed duration contract position.
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.
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.
Region: North America
Req Id: 52273BR