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Clinical Document Lead

1 week ago

Mississauga, Ontario, Canada GlaxoSmithKline Full time
Job Overview:

We are seeking an experienced Senior Clinical Document Lead to join our team at GlaxoSmithKline. As a key member of our regulatory medical writing group, you will be responsible for leading the development of high-quality clinical documents that meet global regulatory requirements.

Responsibilities:
  • Develop and execute complex writing assignments involving clinical trial designs and statistically analyzed research data.
  • Drive and coordinate the process to draft, review, and approve written assignments including marketing application submission documents.
  • Leverage extensive clinical document expertise to support continuous improvement and best practices implementation.

Requirements:
  • 7+ years of advanced regulatory medical writing experience, with prior experience in oncology and understanding of clinical pharmacology concepts advantageous.
  • Advanced understanding of statistical and regulatory concepts, enabling independent writing of complex regulatory documents without supervisor guidance.
  • Proven expertise in completing multiple-document projects, including functioning as lead medical writer for CTD submission dossiers.