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    Quality Medical Reviewer – Medical Affairs Quality

    Lilly
    2-4 years
    Not Disclosed
    Bangalore
    10 Dec. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: LCCI Quality Medical Reviewer – Medical Affairs Quality
    Location: LCCI, Bangalore
    Company: Eli Lilly and Company

    About Eli Lilly and Company

    At Lilly, we unite caring with discovery to improve life for people globally. As a healthcare leader headquartered in Indianapolis, Indiana, we are committed to discovering and delivering life-changing medicines. Our employees worldwide strive to improve the understanding and management of disease, and contribute to their communities through philanthropy and volunteerism. We are determined to make life better for people around the world, and we put people first. We're seeking individuals who share our mission and passion for improving global health.

    Position Overview:

    The Quality Medical Reviewer role in Medical Affairs is pivotal in ensuring that all promotional and non-promotional materials are medically accurate, compliant, and scientifically sound. This role involves reviewing materials, verifying the accuracy of references and data, and collaborating with cross-functional teams to meet regulatory and scientific standards.

    Primary Responsibilities:

    1. Medical Content Review and Approval:

      • Review and ensure that all data in promotional and medical materials match source documentation and are accurately represented throughout the content (including charts, legends, footnotes, etc.).
      • Ensure that data presented is current and consistent with published scientific knowledge.
      • Verify visual representations of data convey the correct results and meaning.
      • Collaborate with cross-functional teams (e.g., Marketing, Medical, Regulatory) during content creation, review, and approval.

    2. Compliance and Quality Assurance:

      • Apply Lilly’s quality standards, policies, procedures, and guidelines during the review process.
      • Ensure that all documents adhere to Lilly’s quality requirements and are presented in a clear, complete, accurate, and concise manner.
      • Uphold adherence to compliance and regulatory standards throughout the document review and approval process.
      • Ensure the timely and effective review of materials to eliminate recurring issues and streamline the process.

    3. Collaboration and Cross-functional Support:

      • Work with various internal teams to address clinical, medical, and scientific content-related queries.
      • Act as a liaison between the CIQ/MCA Lead and Operations teams to track and manage deviations.
      • Offer scientific and medical input and contribute to the development, review, and approval of medical and promotional materials.
      • Facilitate shared-learning forums to establish best practices across teams.

    4. Tools and Systems:

      • Proficiently use platforms such as Veeva Vault, project planning software (Wrike, MS Project), and other content management tools.
      • Maintain high efficiency and quality throughout the review process using various tools and systems to streamline approvals.

    Minimum Qualification Requirements:

    • 2-4 years of experience in scientific/medical editing, copywriting, copyediting, or similar roles in the pharmaceutical or regulated industries (e.g., marketing, advertising, communications).
    • Strong understanding of scientific/medical/statistical terminologies and their application.
    • Proven ability to collaborate with cross-functional teams and make decisions within scope of responsibility.
    • Exceptional written and verbal communication skills.
    • Demonstrated ability to prioritize tasks and handle multiple concurrent projects with strong attention to detail and critical thinking.
    • Ability to work independently or within diverse teams, across geographical and cultural environments.

    Additional Preferences:

    • In-depth knowledge of US CIQ/MCA framework, procedures, and tools (e.g., Veeva Vault, Wrike).
    • Experience in reviewing/writing Medical Affairs communications (e.g., slide decks, patient or HCP materials).
    • Knowledge in therapeutic areas such as neuroscience, oncology, cardiovascular, immunology, endocrinology, or similar fields.

    Educational Requirements:

    • Bachelor’s or Master’s degree in a scientific, health, communications, or technology-related field with a formal research component.

    Why Lilly?
    At Lilly, we are committed to providing equal opportunities to all individuals. If you need accommodation during the application process, please complete the accommodation request form for further assistance.

    #WeAreLilly
    Eli Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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