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    Medical Writing - Medical Affairs

    Lilly
    0-2 years
    Not Disclosed
    Bengaluru 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

    b Title: Medical Writing – Medical Affairs
    Location: LCCI, Bangalore, Karnataka, India
    Category: Medical
    Job Type: Full Time, Regular
    Job ID: R-77901

    Position Description:

    Lilly’s Medical Affairs team focuses on providing balanced, objective, and accurate scientific information throughout the drug development lifecycle. The Medical Writer is responsible for preparing, developing, and finalizing documents that support clinical development and product registration. The role requires writing various types of medical content, including internal training slides, manuscript slides, newsletters, patient education materials, and advisory board presentations. The Medical Writer will play an essential part in delivering clear, credible, and evidence-based communication that meets regulatory and internal guidelines.

    Primary Responsibilities:

    1. Content Strategy and Execution:

      • Collect and evaluate data from multiple sources to develop a cohesive content strategy.
      • Plan, write, edit, review, and coordinate regulatory documents supporting clinical development.
      • Prepare first drafts and conduct document initiation meetings to ensure alignment with teams.
      • Build scientifically sound rationales for complex documents.
      • Present data clearly and concisely while ensuring key data and conclusions are consistent across related documents.
      • Coordinate expert reviews, adjust documents as needed, and ensure final versions are ready for submission.
      • Conduct quality checks to ensure accuracy.

    2. Project and Stakeholder Management:

      • Lead writing projects and apply effective project management skills to ensure timely completion.
      • Build and communicate credible project timelines, mitigate risks, and ensure smooth document development.
      • Work closely with teams to escalate any issues and ensure timely document delivery.
      • Communicate project statuses effectively to stakeholders.

    3. Knowledge and Skills Development:

      • Enhance knowledge in therapeutic areas, disease states, and compounds assigned to projects.
      • Maintain an understanding of regulatory and publication guidelines.
      • Keep abreast of industry and competitor trends and contribute to clinical planning and submission strategy.
      • Continuously develop scientific communication skills, staying updated with new technologies and platforms.

    4. Knowledge Sharing:

      • Coach others by sharing technical information and best practices.
      • Contribute to process improvements and suggest opportunities for refinement.
      • Provide expertise in document management systems and tools.

    Minimum Qualification Requirements:

    • Education:

      • Bachelor’s degree in a scientific, health, communications, or related field.
      • Graduate degree with formal research is preferred.

    • Experience:

      • Demonstrated experience in technical/regulatory scientific writing.
      • Successful completion of a writing exercise as part of the evaluation process.

    • Skills:

      • Strong communication and interpersonal skills.
      • Ability to manage time effectively, especially under tight deadlines.
      • Demonstrated experience in clinical development, clinical trial processes, or regulatory activities.

    Additional Preferences:

    • Experience:
      • Clinical pharmacology, therapeutic areas such as neuroscience, oncology, cardiovascular, immunology, or endocrinology.
      • Experience writing regulatory, clinical trial documents, and publications.
      • Experience in developing Medical Affairs communications (e.g., slide decks, HCP or patient materials).
      • High-level end-user computer skills in word processing, spreadsheets, graphics, and presentation software.

    Other Information:

    • Location: LCCI, Bangalore
    • Lilly's Commitment: Lilly is dedicated to providing equal employment opportunities for individuals with disabilities. If you need accommodation during the application process, please complete the accommodation request form.
    • Equal Opportunity Employer: 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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