Opportunity as Associate - Clinical Trial Labeling in Lilly, Indianapolis
Lilly USA, LLC has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity:
Post: Associate - Clinical Trial Labeling
The Clinical Trial Support Operations team is responsible for providing clinical trial management services and supporting the Demand Management side of the business by providing the following support services: FIPNET Planning, Study Order Management and Ownership, Label Management, Business Process Management, and Business Systems Support &Operations. The purpose of the Label Management Associate role is to leverage deep technical expertise to consistently and accurately create label text that meets the needs of the study and is compliant with all applicable regulatory requirements. This position is responsible for the creation of the label text through review of study and packaging design information and expertise with global regulatory requirements related to label text, submission of the label request, coordination and tracking of master label approval, providing labeling expertise, and following all applicable quality and regulatory requirements in order to consistently and accurately create and deliver IP labels on-time and with quality.
This is not a permanent position. it is for a Fixed Duration of up to 2 years.
1. Execute all position responsibilities in a way that integrates ethics and compliance and follows all applicable regulations, the Corporate Integrity Agreement, The Red Book, and policies related to job content.
2. Create and submit label requests for all CTMS-provided labels Create/select label text for all labels provided by Clinical Trial Material Services (CTMS)
* Develop and maintain technical expertise regarding regulatory requirements for investigational product (IP)label text
* Develop and maintain consistency and standardization in the IP labels provided by CTMS
* 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
* Review and approve label text as the US regulatory approver
* Submit, track, and ensure timely completion of label requests to meet CTMR-start timelines
3. Update and maintain Lillys label phrase library
* Proactively request new phrases/translations to Lillys label phrase library
* Periodically review, request updates, and maintain Lillys label phrase library
4. Execute activities to ensure regulatory compliance of all CTMS-provided labels
* Collaborate with local affiliates and third parties to ensure regulatory modules are accurate and maintained
* Request updates to regulatory requirements in applicable procedures and regulatory modules, as needed
* Create and provide labels for IND applications
* Provide label proofs to affiliates and third parties for regulatory submissions
5. Effectively collaborate with internal and external business partners to provide compliant labels, on-time, for Lilly 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
* Develop and maintain relationships with affiliate and third party regulatory personnel to establish consistent interpretation and application of local regulatory requirements
6. Provide solutions to optimize label business processes
* Proactively identify ways to improve day-to-day activities and practices and actively communicate the opportunities to peers and leadership
* Provide proposals on process improvements or efficiency gains to the Process Owner and 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 with them
7. 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
* Bachelors Degree
* Minimum 3 years experience as a pharmacist, or direct experience working with study drug (site coordinator, clinical research associate, etc.)
* Demonstrated ability to translate study protocol requirements and packaging design into a clearly defined plan for label text
* Must be fluent in English.
* Solid working knowledge of GCP regulations and GMP requirements
* Strong proficiency with computer applications including Microsoft Office products
* Qualified candidate 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 position.
* Pharmacy degree preferred
* Preferred 5 + years experience in a Clinical Trial Material Services or related clinical role.
* Demonstrated effectiveness in influencing across teams, management levels, and ability to work collaboratively
* Strong written and verbal communication skills
* Strong record of performance
* Demonstrated effectiveness performing tasks requiring a strong attention to detail
* Strong interpersonal skills, including capability to engage in professional relationship building and networking
EXP: Min. 3 years
Location: Indiana - Indianapolis
Education: B.S or Bachelors in pharmacy
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: CR
Job ID: 50411618
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