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Bengaluru

    Principal Medical Writer - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 week ago

    GSK background
    OTHER
    Description
    Nome della sede: Bengaluru Luxor North Tower
    Data di apertura: Apr
    • 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.

    Il nostro obiettivo è di essere una delle aziende sanitarie all'avanguardia in termini di innovazione, performance e affidabilità nel mondo. Crediamo che ognuno di noi contribuisca portando qualcosa di unico in GSK e quando uniamo le nostre conoscenze, esperienze e stili, il risultato è fantastico. Unisciti alla nostra avventura in GSK, dove troverai l'ispirazione per lavorare al meglio per i nostri pazienti e consumatori. Un luogo dove puoi essere te stesso, sentirti bene e continuare a crescere.

    Avviso importante per le imprese/agenzie per l'occupazione

    GSK non accetta referenze da parte di aziende e/o agenzie di collocamento in relazione alle offerte di lavoro pubblicate su questo sito. Tutte le aziende/agenzie di collocamento sono tenute a contattare l'ufficio commerciale e il reparto generale/risorse umane di GSK per ottenere un'autorizzazione scritta prima di segnalare eventuali candidati a GSK. L'ottenimento della previa autorizzazione scritta è una condizione sospensiva rispetto a qualsiasi accordo (verbale o scritto) tra l'azienda/agenzia di collocamento e GSK. In assenza di tale autorizzazione scritta ottenuta, qualsiasi azione intrapresa dall'azienda/agenzia di collocamento verrà considerata eseguita senza il consenso o l'accordo contrattuale di GSK. GSK non sarà quindi responsabile per eventuali commissioni derivanti da tali azioni o commissioni derivanti da eventuali segnalazioni da parte di aziende/agenzie di lavoro in relazione alle offerte di lavoro pubblicate su questo sito.

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