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    Global Clinical Publishing Associate

    Novartis
    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    3 LPA to 5 LPA
    Hyderabad
    50 May 28, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Global Clinical Publishing Associate

    Job ID: REQ-10006976

    Date: May 26, 2024

    Location: Hyderabad, India

    Company: Novartis Healthcare Private Limited

    Division: Development

    Business Unit: Pharmaceuticals

    Functional Area: Research & Development

    Employment Type: Full Time, Regular

    Shift Work: No

    Summary: Ensure compliance with internal and external guidelines by compiling and adding electronic navigation to clinical and regulatory documents. Provide publishing consultancy and support the timely submission of these documents to Health Authorities (HAs).

    Key Responsibilities:

    • Document Publishing: Compile, integrate, and publish clinical documents using word processing, electronic publishing, and document management systems within the Novartis Development environment.
    • Quality Control: Perform technical quality control of published documents, ensuring electronic functionality and adherence to document standards.
    • Regulatory Compliance: Maintain knowledge of electronic publishing standards, regulatory guidelines, and legal requirements.
    • Program Support: Act as the Program Publisher under the supervision of the immediate manager for various clinical development programs.

    Key Performance Indicators:

    • Quality and Compliance: Ensure clinical documents meet current quality standards for electronic and/or paper submissions to HAs with minimal technical QC findings and no rework required once finalized.
    • Timeliness: Deliver documents within individual and overall project timelines.

    Minimum Requirements:

    • Experience: Familiarity with regulatory submission formats, including CTD, and submission publishing activities.
    • Skills: Effective interpersonal, communication, and presentation skills; project and time management skills; ability to work independently and with minimal supervision; proficiency in MS Office and capability to quickly learn new systems; analytical and problem-solving skills.
    • Knowledge: Familiar with FDA regulations, ICH, and EMA guidelines/directives; working knowledge of regulatory affairs.
    • Languages: English

    Work Experience:

    • Cross-Cultural Experience: Experience working across different cultures.
    • Functional Breadth: Understanding of operations management, execution, and project management.
    • Collaboration: Proven ability to collaborate across boundaries.

    Why Novartis: Helping people with disease and their families requires more than innovative science—it takes a community of smart, passionate individuals. At Novartis, you will collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives.

    Join our Novartis Network: If this role isn’t right for you, join our talent community to stay connected and learn about upcoming career opportunities. Sign up here.

    Application Link: Novartis Careers

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