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    Quality Medical Reviewer – Medical Affairs Quality

    Lilly
    2-4 years
    Not Disclosed
    Bangalore India
    10 Feb. 11, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Quality Medical Reviewer – Medical Affairs Quality
    Location: LCCI, Bangalore, Karnataka, India
    Category: Medical
    Job Type: Full Time, Regular
    Job ID: R-64790

    Purpose of the Role:

    The Quality Medical Reviewer plays a critical role in reviewing and approving both medical (non-promotional) and promotional materials, ensuring they are scientifically accurate, appropriately referenced, and compliant with Lilly's internal policies, procedures, and industry regulations. The role involves collaboration with cross-functional teams to provide scientific and clinical inputs, ensuring that materials meet Lilly’s quality standards and are consistent with the latest published scientific data.

    Primary Responsibilities:

    1. Review and Approve Materials:

      • Review promotional and medical (non-promotional) materials to ensure alignment with Lilly’s quality requirements (CIQ, MCA) and industry standards.
      • Verify that data values match the source documentation and are consistently presented across the document.
      • Ensure visual representations of data accurately convey the intended meaning.
      • Confirm that information is clear, concise, accurate, and current with the latest scientific knowledge.
      • Ensure consistency across related documents and that conclusions are well-supported by appropriate data.

    2. Collaboration with Cross-Functional Teams:

      • Work with cross-functional teams (Marketing, Medical Affairs, Regulatory, etc.) during the review and approval of content.
      • Attend review meetings as required and provide scientific input to the review process.
      • Address questions related to clinical/medical/scientific content promptly and effectively.
      • Ensure timely review and approval of materials, following Lilly’s internal standards and processes.

    3. Quality, Speed, and Compliance:

      • Ensure the review process is conducted with quality, efficiency, and adherence to regulatory and company standards.
      • Identify and manage deviations from the review process, working with CIQ/MCA teams to implement corrective actions.
      • Contribute to the development and refinement of processes and standards to ensure quality and compliance.

    4. Scientific and Medical Input:

      • Offer scientific and medical input to the development, review, and approval of promotional and medical materials.
      • Ensure that content reflects the most current knowledge in therapeutic areas such as neuroscience, oncology, cardiovascular, immunology, or endocrinology.
      • Collaborate with the brand teams and regulatory teams to ensure all materials are medically accurate and in compliance with the applicable regulatory requirements.

    Minimum Qualification Requirements:

    • Experience:

      • 2-4 years of experience working as a scientific/medical editor, copywriter, or copyeditor in a regulated industry, preferably within the pharmaceutical or healthcare sectors.
      • Strong understanding of scientific/medical/statistical terminologies.
      • Proven ability to work effectively in cross-functional teams, influence decisions, and manage multiple concurrent tasks.
      • Attention to detail and strong critical thinking skills.
      • Experience with project planning software (e.g., Wrike, MS Project) and tools like Veeva Vault.

    • Skills:

      • Excellent written and verbal communication skills.
      • Ability to work independently or collaboratively in diverse environments.
      • Ability to make decisions within the scope of responsibility and manage competing priorities.

    • Education:

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

    Additional Preferences:

    • Familiarity with the US CIQ/MCA framework, procedures, and tools (e.g., Veeva Vault, Wrike).
    • Experience reviewing and writing Medical Affairs communications (e.g., slide decks, patient or HCP materials).
    • Expertise in therapeutic areas such as neuroscience, oncology, cardiovascular, immunology, or endocrinology.

    Other Information:

    • Location: LCCI, Bangalore
    • Lilly's Commitment: Lilly is dedicated to ensuring individuals with disabilities have the opportunity to engage in the workforce. If accommodations are needed during the application process, please complete the accommodation request form.
    • Equal Opportunity Employer: 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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