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    Associate - Medical Affairs Uk Tmr

    Lilly
    3+ years
    Not Disclosed
    Bangalore
    10 Dec. 26, 2024
    Job Description
    Job Type: Full Time Education: MSc./M. Pharm/PhD 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: UK Technical Medical Reviewer
    Location: LCCI, Bangalore
    Company: Eli Lilly and Company

    About Eli Lilly and Company

    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, we are dedicated to discovering and delivering life-changing medicines, improving disease management, and supporting our communities through philanthropy and volunteerism. Our employees globally are committed to making a meaningful difference, and we seek individuals determined to improve lives worldwide.

    Position Overview:

    The UK Technical Medical Reviewer plays a critical role in ensuring that promotional materials are medically accurate and aligned with regulatory documents, scientific literature, and external guidelines (e.g., UK ABPI and Irish IPHA Codes). Working closely with brand teams, medical advisors, and other internal and external stakeholders, this role involves reviewing medical content in promotional materials, ensuring compliance with all relevant regulations, and providing strategic oversight of the UK PMAP process. Additionally, the role involves process improvement, training, and creating actionable insights for senior leadership.

    Key Objectives/Deliverables:

    1. Review and Approve Medical Content:

      • Ensure that promotional materials are medically accurate and compliant with regulatory documents (e.g., Summary of Product Characteristics, Prescribing Information).
      • Verify that all statements, claims, and data values in the materials are supported by up-to-date references and scientific literature (e.g., peer-reviewed journals, clinical data).
      • Review visual representations of data to ensure accuracy and clarity.
      • Ensure compliance with UK ABPI and Irish IPHA Codes, focusing on the balance of efficacy and safety, correct placement of black triangle, prescribing information, and adverse event reporting statements.
      • Ensure correct formatting, grammar, spelling, and alignment with Lilly style guides (Brand Book, Product Guidelines, etc.).

    2. PMAP Process Execution and Improvement:

      • Deliver functional training to new hires in marketing and medical teams.
      • Provide oversight and feedback on PMAP procedures, ensuring alignment with regulatory and internal guidelines.
      • Monitor PMAP processes, identify bottlenecks, and propose solutions for continuous improvement.
      • Produce metrics and reports for UK leadership, highlighting issues with capacity, quality, and compliance.

    3. Process Improvement and Data Analysis:

      • Use Lean and Six Sigma principles to identify and eliminate bottlenecks, variations, and redundant steps within the PMAP workflow.
      • Analyze data quality metrics and trends to support data-driven decision-making and process optimization.
      • Lead initiatives for defining and refining best practices and metrics for UK teams.

    4. Cross-Functional Leadership and Collaboration:

      • Lead cross-functional initiatives to improve the PMAP process, ensuring strategic alignment across brand teams and medical certifiers.
      • Participate in Six Sigma workstreams to design and improve workflows and processes within PMAP.
      • Support transformation initiatives, process changes, and risk management in pre-launch activities.

    Minimum Experience/Personal Skill Requirements:

    • At least 3 years of experience in editing, copywriting, or proofreading.
    • Proven ability to influence, collaborate, and work effectively on cross-functional teams.
    • Strong attention to detail, with a demonstrated ability to prioritize and manage multiple tasks.
    • Learning agility, proactivity, and problem-solving skills.

    Additional Preferences:

    • Strong self-management and motivation, with the ability to anticipate challenges and provide solutions.
    • Familiarity with Veeva Vault PromoMats.
    • In-depth skills in analysis, judgment, and decision-making, with a focus on quality and continuous improvement.
    • Proven planning and organizational skills.

    Education Requirements:

    • Master’s degree or equivalent experience in a scientific discipline.

    Other Information:

    • Location: LCCI, Bangalore
    • Minimal travel expected: <10%

    Lilly is committed to providing equal opportunities for individuals with disabilities to engage in the workforce. If accommodations are needed during the application process, please complete the accommodation request form here.

    Lilly 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.
    #WeAreLilly

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