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    Associate Director - Medical Writing

    Novo Nordisk
    9+ years
    Not Disclosed
    Lexington
    10 Jan. 3, 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: Associate Director, Medical Writing
    Location: Lexington, United States
    Job Category: Clinical Development

    Apply Now

    About the Department:

    At Novo Nordisk, our East Coast Global Development Hub in Lexington, MA and Plainsboro, NJ is home to some of the best minds in life science innovation. We support programs from early research through late-stage clinical development. Our team is building a dynamic and collaborative R&D community that focuses on cutting-edge research and innovative therapeutic modalities. We merge biotech speed with the quality, resources, and stability of a large pharmaceutical company to create new medicines for patients. If you're ready to make a difference, we invite you to join us in changing lives.

    The Position:

    The Associate Director, Medical Writing (ADMW) is a highly skilled professional in medical writing, working independently with minimal supervision. The ADMW will collaborate with cross-functional teams such as Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs to prepare written deliverables for clinical development and regulatory submissions. This role involves providing strategic input into development plans, study designs, and regulatory filings, ensuring the clear communication of complex clinical data.

    Key Responsibilities:

    Document Preparation & Strategic Input:

    • Lead the development of critical clinical and regulatory documents, including clinical trial protocols, clinical study reports (CSRs), and investigational new drug applications (INDs).
    • Provide strategic guidance for regulatory submissions and clinical studies, ensuring documents meet the needs of target audiences and align with the development program.
    • Author and review a variety of documents such as clinical evaluation reports (CERs), investigator brochures (IBs), and regulatory responses.

    Collaboration & Leadership:

    • Collaborate with cross-functional teams to develop key messages for complex documents.
    • Lead the sharing of best practices and standardization of processes within the medical writing team.
    • Participate in relevant meetings, training sessions, and presentations, actively contributing to the continuous improvement of medical writing practices.

    Team Leadership & Mentorship:

    • Provide leadership and mentorship to less-experienced medical writers.
    • Ensure development plans are in place for reporting personnel to align with business priorities, including interim reviews and performance tracking.

    General Tasks & Project Management:

    • Lead and drive decision-making within project teams, especially regarding medical writing issues.
    • Oversee the quality of documents, providing constructive feedback and ensuring high standards.
    • Resolve complex problems related to medical writing tasks and provide guidance to junior team members.

    Physical Requirements:

    • 10% overnight travel may be required, including international travel.

    Qualifications:

    Education & Experience:

    • Minimum BS/BA degree, preferably in a health-related or scientific field.
    • 9+ years of relevant experience, with at least 8 years in clinical or regulatory medical writing in a pharmaceutical, biotechnology, or CRO environment.
    • Experience in preparing drug applications for FDA and EMA is essential; familiarity with applications in Japan and China is a plus.

    Skills & Expertise:

    • Strong understanding of clinical research, the drug/device development process, and regulatory guidelines.
    • Expertise in statistical analysis and clinical study design.
    • Exceptional communication skills, with proficiency in English grammar and punctuation.
    • Ability to collaborate across time zones and manage projects efficiently in a global environment.

    Additional Experience:

    • Experience in cell therapies or advanced therapeutics is highly desirable.

    Why Join Novo Nordisk:

    At Novo Nordisk, we are committed to fostering an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities in which we operate. We know that to be the best company for the world, we need diverse perspectives and backgrounds to make a real impact. Together, we’re life-changing.

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