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Bengaluru

    Principal Medical Writer - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 week ago

    GSK background
    OTHER
    Description
    工作地點名稱: Bengaluru Luxor North Tower
    刊登日期: 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.

    我們的目標是成為全世界最具創新能力、績效最佳且最值得信賴的醫療照護公司之一。我們相信我們每個人都為 GSK 帶來獨特的東西,而且當我們將我們的知識、經驗和風格結合在一起時,就會產生令人難以置信的影響力。歡迎加入我們在 GSK 的探險行列,在這裡您將會受到啟發,為我們的病患和消費者拿出您的最佳表現。在這裡您可以盡情做您自己、體驗美妙的感受,並且不斷成長。

    給職業介紹公司/介紹所的重要通知

    GSK 不接受職業介紹公司及/或職業介紹所針對本網站公佈的職缺所做的推薦。所有職業介紹公司/介紹所都必須先連絡 GSK 的商業和一般採購/人力資源部門來取得事先的書面授權,然後才可以推薦任何候選者給 GSK。取得事先的書面授權是職業介紹公司/介紹所與 GSK 之間達成任何協議 (口頭或書面) 的先決條件。如果沒有獲得此類書面授權,職業介紹公司/介紹所所採取的任何行動均應視為未經 GSK 同意或合約協議而進行。因此,關於本網站所公佈的職缺,GSK 對於職業介紹公司/介紹所因此類行為所產生的任何費用或是因任何推薦所產生的任何費用概不負責。

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