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    Associate - Label Management

    Eli Lily
    3+ years
    Not Disclosed
    Indianapolis
    10 Jan. 31, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: : Associate - Label Management
    Location: Indianapolis, Indiana, United States of America
    Category: Research & Development
    Job Type: Full Time, Regular
    Job ID: R-78645

    Company Overview:
    At Eli Lilly, we are committed to uniting caring with discovery to make life better for people around the world. As a global healthcare leader, we work tirelessly to discover and deliver life-changing medicines. Our employees are dedicated to improving the understanding and management of disease and giving back to our communities through volunteerism and philanthropy. We are looking for determined individuals to help us make life better for people worldwide.

    Position Summary:
    The Label Management Associate is responsible for ensuring the accurate and timely creation of investigational product labels for clinical trials. This role requires collaboration with various internal and external stakeholders, including Clinical Supply and Delivery teams, to ensure labels meet regulatory requirements and project timelines. The Associate will also provide technical expertise and continuous improvement in label creation processes.

    Key Responsibilities:

    • Label Creation and Management:

      • Create and submit label requests for clinical trial labels as part of Clinical Supply and Delivery.
      • Develop label text in alignment with study protocols and packaging designs, ensuring accuracy and consistency.
      • Collaborate with internal and external partners to ensure timely creation and approval of compliant labels.
      • Proactively propose new phrases for inclusion in Lilly’s label phrase library.

    • Regulatory and Quality Compliance:

      • Maintain technical expertise in regulatory requirements for investigational product label text.
      • Ensure all labels comply with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other regulatory guidelines.
      • Review study protocols, packaging designs, and forecasts to ensure label accuracy and compliance.
      • Follow all quality and regulatory procedures to ensure the timely delivery of labels.

    • Collaboration and Communication:

      • Work closely with Supply Planning, Label Project Coordinators, Clinical Development, third-party vendors, and other stakeholders.
      • Track the progress of label requests to ensure timely completion and alignment with packaging order start timelines.
      • Communicate proactively with cross-functional teams to resolve any issues or delays in label creation.

    • Continuous Improvement:

      • Identify opportunities to optimize the label creation process by reducing timelines, cutting costs, and minimizing risks.
      • Contribute to process improvement initiatives to streamline the label management process.
      • Provide solutions to enhance the overall Clinical Supply and Delivery master label creation and approval process.

    • Metrics and Reporting:

      • Collect and report metrics related to label creation and delivery.
      • Monitor performance and propose improvements to optimize label management processes.

    • Mentorship and Training:

      • Mentor and provide guidance to junior Label Management Associates.
      • Participate in special projects and reviews to ensure continuous development and adherence to industry best practices.

    Basic Qualifications:

    • Bachelor’s degree, preferably in pharmacy, health-related fields, science, or engineering, or equivalent work experience.

    Experience and Skills Required:

    • Minimum 3 years of experience in Clinical Supply and Delivery or a related clinical/regulatory role.
    • Strong attention to detail and ability to accurately translate study protocols and packaging designs into clear label text.
    • Solid understanding of GCP and GMP regulations.
    • Strong proficiency in Microsoft Office products.
    • Excellent written and verbal communication skills with the ability to collaborate across teams.
    • Strong interpersonal skills, including the ability to build professional relationships and networks.

    Preferred Qualifications:

    • Experience with Quality Assurance in regulated environments.
    • Project management experience in clinical supply or related functions.
    • Familiarity with TrackWise and SAP systems.
    • Experience in Clinical Trial Supply Management.

    Other Information:

    • This is expected to be a hybrid role, with a majority of the time spent on-site.
    • Compensation: The anticipated wage for this position is $63,000 - $140,800, dependent on the candidate's experience, skills, and location.

    Lilly’s Commitment to Diversity and Inclusion:
    Eli Lilly is an EEO/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. Lilly is committed to providing an inclusive workplace for all employees.

    Benefits:
    Lilly offers a comprehensive benefits package, including eligibility for a company-sponsored 401(k), medical, dental, vision benefits, flexible spending accounts, life insurance, vacation, well-being benefits, and more.

    Application Process:
    If you require accommodation to submit a resume for this position, please complete the accommodation request form through the provided link.

    Join our team at Lilly to make life better for people around the world.

    #WeAreLilly 

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