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    Senior Medical Writer

    Novo Nordisk
    7+ years
    Not Disclosed
    Lexington
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: BS/BA 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: Senior Medical Writer

    Location: East Coast Global Development Hub (Lexington, MA, and Plainsboro, NJ)
    Company: Novo Nordisk

    About the Department

    Our East Coast Global Development Hub is at the forefront of life science innovation, combining biotech speed and agility with the resources and stability of a large pharmaceutical company. Based in Lexington, MA, and Plainsboro, NJ, we support programs from early research through late-stage clinical development.

    By fostering collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas, we aim to develop groundbreaking medicines for patients. At Novo Nordisk, improving human health begins with our efforts, and patients rely on us.

    We’re changing lives for a living. Are you ready to make a difference?

    The Position

    As a Senior Medical Writer, you will collaborate with cross-functional teams to manage and prepare written deliverables that support clinical development and regulatory submissions. Your work will be critical in ensuring the clarity, accuracy, and quality of clinical documents, supporting Novo Nordisk's mission to change lives.

    Key Relationships

    The Senior Medical Writer reports to a Director of Medical Writing and collaborates with internal global and local cross-functional teams, including:

    • Medical & Science
    • Clinical Pharmacology
    • Biostatistics
    • Clinical Operations
    • Regulatory Affairs
    • Global Safety
    • Data Management
    • Non-clinical Development

    Essential Functions

    Document Development:

    • Prepare and review clinical trial and regulatory documents, including:
      • Protocols and amendments
      • Clinical study reports (CSRs)
      • Investigator brochures (IBs)
      • Informed consent forms
      • Lay summaries of clinical trial results
      • Clinical evaluation plans (CEPs) and reports (CERs)
      • Regulatory submissions (eCTD format)

    Collaboration and Improvement:

    • Review study plans for alignment with audience needs.
    • Contribute to process improvements and knowledge sharing.
    • Lead discussions on trial-specific medical writing issues.

    Leadership and Quality Assurance:

    • Interpret clinical and statistical data accurately.
    • Ensure document accuracy, consistency, and compliance with regulatory standards.
    • Provide training and mentorship to team members.

    General Tasks:

    • Resolve content issues during document development.
    • Manage multiple tasks and navigate uncertainty effectively.
    • Maintain knowledge of industry standards, regulations, and company policies.

    Qualifications

    Education:

    • Minimum: BS/BA, preferably in a health-related or scientific discipline.

    Experience:

    • 7+ years of relevant experience.
    • 5+ years of clinical/regulatory medical writing in pharmaceutical, biotechnology, or CRO environments.

    Technical Skills:

    • Mastery of English grammar and exceptional written/oral communication skills.
    • Deep understanding of clinical research principles and drug/device development.
    • Attention to detail for document accuracy and consistency.
    • Strong scientific foundation to interpret trial data and literature.

    Preferred Expertise:

    • Experience with cell therapies/advanced therapeutics or metabolic dysfunction-associated steatohepatitis (MASH).

    What We Offer

    At Novo Nordisk, we are committed to creating an inclusive environment that celebrates diversity and supports your professional growth. Our benefits include:

    • Competitive salary and rewards.
    • Career development opportunities.
    • Supportive, collaborative workplace culture.

    Equal Opportunity Employer

    Novo Nordisk is committed to an inclusive recruitment process. We provide equal employment opportunities to all applicants and reasonable accommodations for those requiring assistance.

    For accommodation requests, call 1-855-411-5290.

    Join us and be part of a company that’s changing lives. Together, we’re life-changing.

    Apply now: careers.novonordisk.com

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