Associate Label Management - OneTenCoalition
Indianapolis, IN
About the Job
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
Effectively collaborate with internal/external partners to provide compliant labels, on-time, for clinical trials
Provide solutions to optimize the Clinical Supply and Delivery master label creation and approval process
Additional responsibilities may include:
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:
Additional Preferences:
This is expected to be a hybrid role with majority of the time spent on-site.
License/Certificate Requirements: None (Pharmacist preferred)
Language Requirements: Must speak fluent English
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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
- Strong record of performance
- 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
- Solid working knowledge of GCP regulations and GMP requirements
- Strong proficiency with computer applications including Microsoft Office products
Additional Preferences:
- Knowledge and experience working with Quality Assurance in a highly regulated area and relevant external experience, preferably within the industry
- Project management experience
- Solid working knowledge of Clinical Trial Supply Management fundamentals
- TrackWise experience
- SAP experience
This is expected to be a hybrid role with majority of the time spent on-site.
License/Certificate Requirements: None (Pharmacist preferred)
Language Requirements: Must speak fluent English
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Source : OneTenCoalition