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Principal Medical Writer

2 months ago

Bengaluru, India GSK Full time
Nom du site: Bengaluru Luxor North Tower
Data de publication: Apr 30 2024
  • 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.

Notre objectif est d'être l’une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique. Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable. Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients. Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.

  

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