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Bengaluru

    Principal Medical Writer - Bengaluru, India - GSK

    GSK
    GSK Bengaluru, India

    1 week ago

    GSK background
    OTHER
    Description
    Nome do Local: Bengaluru Luxor North Tower
    Data da Publicação: 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.

    Nossa meta é ser uma das empresas da área de saúde mais inovadoras, com o melhor desempenho e confiáveis do mundo. Acreditamos que todos nós trazemos algo de exclusivo para a GSK, e quando combinamos nosso conhecimento, experiências e estilos, o impacto é incrível. Venha participar de nossa aventura na GSK onde você será inspirado a fazer seu melhor trabalho para nossos pacientes e consumidores. Um lugar onde você pode ser você mesmo, sentir-se bem e continuar crescendo.

    Notificação importante para empresas/agências de emprego

    A GSK não aceita indicações de empresas e/ou agências de emprego para as vagas publicadas neste site. Todas as empresas/agências de emprego devem entrar em contato com o departamento de recursos humanos/aquisição geral e comercial da GSK para obter autorização prévia, por escrito, antes de indicar quaisquer candidatos para a GSK. A obtenção da autorização prévia, por escrito, é uma condição anterior a qualquer acordo (verbal ou por escrito) entre a empresa/agência de emprego e a GSK. Na ausência dessa autorização por escrito, será considerado que todas as ações foram executadas pela empresa/agência de emprego sem o consentimento ou o acordo contratual da GSK. Dessa forma, a GSK não será responsável por valores decorrentes dessas ações nem por valores decorrentes de indicações feitas por empresas/agências de emprego para as vagas publicadas neste site.

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