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Lilly Associate-Label Management-FDE in Indianapolis, Indiana

Job Category:

Other

Type of Employment:

Fixed Duration Employment – FDE

Responsibilities:

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.

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 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

Additional Responsibilities

  • 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 Qualificiations:

  • 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

Additional Skills/Preferences:

  • 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

Additional Information:

  • 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.

Company Overview:

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.

#WeAreLilly

Posted Date:

Keyword:

Region: North America

City: Indianapolis

State: Indiana

Country: USA

Location Details:

Req Id: 52273BR

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