Principal Medical Writer

gssi.world

Base: cad118,000 to cad168,000; bonus/equity: annu...
Hybrid
Advanced medical writing expertise
Independent management of regulatory projects
Deep understanding of clinical trial designs
The role involves authoring high-quality clinical regulatory documents such as protocols, Clinical Study Reports, and Investigator's Brochures for global submissions

Job Summary

  • The role involves authoring high-quality clinical regulatory documents such as protocols, Clinical Study Reports, and Investigator's Brochures for global submissions.
  • Candidates must demonstrate the ability to independently lead complex writing projects and interpret complex clinical and statistical information into clear narratives.
  • GSK offers a competitive salary range of CAD118,000 to CAD168,000 along with healthcare, pension plans, shares, and a hybrid working model.

Matching Summary

The role involves authoring high-quality clinical regulatory documents such as protocols, Clinical Study Reports, and Investigator's Brochures for global submissions.

Salary

Base: CAD118,000 to CAD168,000; Bonus/Equity: Annual bonus based on company performance; Benefits: Healthcare, pension plan, shares and savings programme

Skills & Requirements

Must-have

  • Advanced medical writing expertise
  • Independent management of regulatory projects
  • Deep understanding of clinical trial designs
  • Statistical analysis interpretation skills
  • Experience with CTD submission dossiers

Nice-to-have

  • Leadership in global multicultural environments
  • Knowledge of ICH guidelines and GCP
  • Ability to use document automation tools
  • Strong written and verbal English communication

Key Requirements

  • PhD or equivalent relevant experience within life sciences
  • Advanced experience in clinical regulatory medical writing
  • Proven leadership capability in matrixed environments

Work Rights

Not specified

Tailored Resume

Cover Letter