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    Medical Affairs – Medical Writing

    Lilly
    2+ 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: Medical Affairs – Medical Writing
    Location: Varies by site or geographic location
    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 work to discover and deliver life-changing medicines, enhance disease management, and contribute to our communities through philanthropy and volunteerism. Our employees globally are dedicated to making a difference, and we seek individuals committed to improving lives worldwide.

    Position Overview:

    Medical Affairs (MA) plays a crucial role at Lilly, ensuring that scientific data is communicated in a clear, accurate, and balanced manner to various stakeholders such as regulators, healthcare professionals, patients, and the scientific community. The Medical Writing role is pivotal in supporting the development of regulatory documents, medical communications, and educational content that helps guide clinical development and product registration. This role involves planning, writing, editing, and managing the lifecycle of medical content for a range of materials.

    Primary Responsibilities:

    1. Document Development and Content Strategy:

      • Gather, evaluate, and synthesize data to create comprehensive content strategies for writing projects.
      • Write, edit, review, and finalize documents for regulatory submissions, ensuring clarity, accuracy, and alignment with scientific data.
      • Conduct document initiation meetings, ensuring alignment across the authoring team.
      • Build evidence-based rationales for complex documents and ensure key messages are consistent and well-supported by data.
      • Coordinate expert reviews and integrate feedback into final documents while ensuring compliance with regulatory standards.
      • Ensure high-quality checks for accuracy across multiple document types and manage revisions effectively.

    2. Project and Stakeholder Management:

      • Lead writing projects, applying strong project management skills to ensure timely delivery of high-quality regulatory documents.
      • Communicate project timelines, anticipate risks, and manage resource allocation to meet deadlines.
      • Collaborate with stakeholders to ensure smooth document development and escalate issues when necessary.

    3. Knowledge and Skills Development:

      • Maintain and enhance expertise in therapeutic areas, including the relevant compounds and disease states for assigned projects.
      • Stay updated on regulatory guidelines, medical communications trends, and changes in technology and platforms.
      • Ensure effective scientific communication that aligns with audience needs and evolving regulatory demands.
      • Participate in clinical planning, submission strategies, and literature reviews as needed.

    4. Knowledge Sharing and Process Improvement:

      • Coach others in document development processes and technical writing.
      • Share best practices and contribute to process improvement initiatives within the medical writing team.
      • Offer expertise in document management systems and tools to enhance team efficiency.

    Minimum Qualification Requirements:

    • Bachelor’s degree in a scientific, health, or communications-related field.
    • Proven experience in technical/regulatory scientific writing.
    • Strong communication and interpersonal skills.
    • Successful completion of a writing exercise as part of the evaluation process.

    Additional Preferences:

    • Graduate degree with a formal research component (e.g., life sciences).
    • Mastery of verbal and written English in medical, scientific, or technical writing fields.
    • Expertise in clinical pharmacology, therapeutic areas (e.g., neuroscience, oncology, cardiovascular, immunology, endocrine), and clinical development.
    • Experience writing regulatory documents, clinical trial documents, or publications.
    • Knowledge of Medical Affairs communications (e.g., slide decks, patient or HCP materials).
    • Project management and time management skills.
    • Proficiency in end-user computer skills (e.g., word processing, tables/graphics, spreadsheets, presentation tools).

    Other Information:

    • Location: Varies by site or geographic location
    • Lilly is dedicated to providing equal employment opportunities to individuals with disabilities. If accommodations are required to apply for a position at Lilly, please complete the accommodation request form here.

    Lilly is an equal opportunity employer and 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.
    #WeAreLilly

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