Principal Medical Writer

Gsicareers

Cad118,000 to cad168,000; not specified; not speci...
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Clinical regulatory medical writing
Author complex regulatory documents
Clinical trial design understanding
** GSK is seeking a Principal Medical Writer with substantial experience in regulatory writing and a strong understanding of clinical trials. The role involves managing complex writing projects and producing high-quality clinical documents while working in a hybrid environment that promotes employee growth and well-being. **

Job Summary

  • Author and deliver high-quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions.
  • Partner within cross-functional, matrix teams to produce fit-for-purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements.
  • We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.

Matching Summary

Match Score: 75

** GSK is seeking a Principal Medical Writer with substantial experience in regulatory writing and a strong understanding of clinical trials. The role involves managing complex writing projects and producing high-quality clinical documents while working in a hybrid environment that promotes employee growth and well-being. **

Salary

CAD118,000 to CAD168,000; Not specified; Not specified

Skills & Requirements

Must-have

  • clinical regulatory medical writing
  • author complex regulatory documents
  • clinical trial design understanding
  • statistical analysis interpretation
  • global regulatory submissions
  • cross-functional matrix teams

Nice-to-have

  • ambitious for patients culture
  • agile working culture
  • healthcare and wellbeing programmes
  • modern work practises

Key Requirements

  • PhD or equivalent relevant experience
  • Advanced experience in clinical regulatory medical writing
  • Demonstrated ability to independently author complex regulatory documents
  • Strong understanding of clinical trial design, regulatory requirements, statistical concepts
  • Proven leadership capability
  • Working knowledge of ICH guidelines, Good Clinical Practice (GCP)

Work Rights

Not specified

Tailored Resume

Cover Letter