Principal Medical Writer

3 weeks ago


Bengaluru, India GSK Full time
Standort: Bengaluru Luxor North Tower
Datum: Apr 30 2024

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.

Unser Ziel ist es, eines der innovativsten, leistungsfähigsten und vertrauenswürdigsten Gesundheitsunternehmen der Welt zu werden. Wir sind davon überzeugt, dass jeder von uns einen einzigartigen Beitrag zu GSK leistet. Wenn wir unser Wissen, unsere Erfahrungen und besonderen Talente vereinen, werden wir ein unglaubliches Ergebnis erzielen. Kommen Sie zu GSK und finden Sie einen inspirierenden Arbeitsplatz, an dem Sie Ihr Bestes für unsere Patienten und Verbraucher geben. Ein Ort, an dem Sie ganz Sie selbst sein, sich wohlfühlen und weiterentwickeln können.

  

Wichtiger Hinweis für Arbeitsvermittlungsunternehmen/‑agenturen

GSK akzeptiert keine Empfehlungen von Arbeitsvermittlungsunternehmen und/oder Arbeitsvermittlungsagenturen für die auf dieser Website ausgeschriebenen freien Stellen. Alle Arbeitsvermittlungsunternehmen/‑agenturen müssen sich an die Abteilung für gewerbliche und allgemeine Beschaffung/Personalabteilung von GSK wenden, um die schriftliche Einwilligung einzuholen, bevor sie GSK Bewerber empfehlen. Der Erhalt einer schriftlichen Einwilligung  ist Voraussetzung für jegliche Vereinbarung (sowohl mündlich als auch schriftlich) zwischen dem Arbeitsvermittlungsunternehmen/der Arbeitsvermittlungsagentur und GSK. Falls diese Genehmigung nicht erteilt wurde, wird davon ausgegangen, dass sämtliche Handlungen des Arbeitsvermittlungsunternehmens/der Arbeitsvermittlungsagentur ohne die Zustimmung von GSK oder ohne eine vertragliche Vereinbarung mit GSK unternommen wurden. Aus diesem Grund haftet GSK nicht für irgendwelche Gebühren, die aus solchen Handlungen oder aus Empfehlungen von Arbeitsvermittlungsunternehmen/‑agenturen für die auf dieser Website ausgeschriebenen freien Stellen entstehen.



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