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Bengaluru

    Principal Medical Writer - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 week ago

    GSK background
    OTHER
    Description
    工厂名称: Bengaluru Luxor North Tower
    发布日期: Apr

    Key Responsibilities (suggested no more than 10 bullet points)

    • Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
    • Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
    • Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
    • Demonstrated effectiveness in management of projects of increasing scope and complexity.
    • Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
    • Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
    • High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
    • Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
    • Review reporting and analysis plans and provides critical input on the content and display of tables.
    • Familiarity with approaches to expedite document preparation such as review tools and automation.
    • Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
    • Effectiveness in both oral and written communications.

    我们的目标是成为全球最具创新精神、业绩最佳、最值得信赖的医疗保健公司之一。我们相信,我们所有人都为 GSK 带来了一些独特的东西,当我们把我们的知识、经验和风格结合在一起时,将会实现令人难以置信的影响力。欢迎加入 GSK,您将受到启发,为我们的患者和消费者提供最好的服务。在这里,您可以做你自己,在愉悦的工作环境中不断发展进步。

    面向职业介绍所/就业机构的重要通知

    GSK 不接受职业介绍所和/或就业机构就本网站上发布的职位空缺所做的引荐。所有职业介绍所/就业机构均须联系 GSK 的商业及一般采购/人力资源部门,以取得事先书面授权,才可将任何应聘者推荐给 GSK。取得事先书面授权是职业介绍所/就业机构与 GSK 之间达成任何协议(口头或书面)的先决条件。在没有获得书面授权的情况下,职业介绍所/就业机构所采取的任何行动均应被视为未经 GSK 同意或在未达成合同协议的情况下进行。因此,GSK 无须就此类行动或职业介绍所/就业机构就本网站所发布的职位空缺进行的引荐所产生的任何费用负责。

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