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mimi

Principal Medical Writer

GSK

Canada · On-site Full-time Lead 1mo ago

About the role

About

Shape clinical data into regulatory documents with GSK as a Principal Medical Writer in Warsaw. This role focuses on collaboration with clinical, safety, and regulatory teams in document creation.

As a Principal Medical Writer, you'll create essential documents like protocols and clinical study reports. With a strong emphasis on scientific judgement and problem-solving, your work will have a direct impact on international regulatory submissions. You'll mentor junior writers while managing complex projects and adapting to evolving therapeutic priorities.

Responsibilities

  • Write a range of clinical and regulatory documents
  • Collaborate with matrix teams for document quality
  • Contribute to international regulatory submission dossiers
  • Assess complex situations for scientific solutions
  • Mentor junior writers and manage project complexities

Requirements

  • PhD or equivalent expertise
  • 5 years in clinical regulatory writing
  • Understanding of drug development processes
  • Strong English communication skills
  • Familiarity with ICH/GCP standards

Bring your expertise in clinical writing and data interpretation to GSK in Warsaw.

Skills

GCPICH

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