Senior Associate Label Management Fixed Duration Employment

Company Name:
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
The Clinical Trial Supply Planning team is responsible for providing Investigational Product (study drug) management
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 Manufacturing and Services (CTMMS) teams, creating label text, submiting 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.
Key Responsibilities:
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 Demand Management Associates (DMA)
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 DCOE and external partners, including DMAs, Clintrak Label Coordinators, Supply Management Associates, Outsourcing group, Clinical Development Organization, third parties, global affiliates, Japan-CTSCs, 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 Lillys 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
Additional responsibilities may include:
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
Basic Qualifications:
Bachelors degree
Minimum 3 years experience in a Clinical Trials, Pharmacy operations, the Health Care industry, or related field
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 these positions.
Additional Skills/Preferences:
Pharmacist (RPh or PharmD) preferred.
License/Certificate Requirements: None (Pharmacist preferred)
Language Requirements: Must speak fluent English
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
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
Knowledge and experience working with QC in highly regulated area and relevant external experience, preferably within the industry, are highly beneficial.
Additional Information:
This position is not permanent. It is for a fixed duration for up to 4 years.
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
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