Elevate your career as a Senior Principal Medical Writer with a focus on Chemistry, Manufacturing, and Controls documentation in a fully remote setup. This role requires strong regulatory writing expertise and project leadership skills.

Our partner company is seeking a Principal Medical Writer based in Canada. This senior role demands a high level of ownership over complex documents while engaging across various therapeutic areas such as biologics and gene therapy. You will mentor peers and influence submission strategies crucial for regulatory approvals.

Key Responsibilities:
• Lead development of high-quality regulatory CMC documents
• Own and author key submissions, including Module 3 sections
• Manage project teams and coordinate contributions




• Synthesize information for regulatory content and reports
• Provide guidance on document preparation and review

Requirements:
• Bachelor’s degree in a scientific discipline preferred
• 7+ years of regulatory writing experience
• Proven expertise with CMC submissions, especially Module 3
• Robust knowledge of regulatory pathways and guidelines
• Excellent communication and leadership skills

Your expertise in regulatory writing can significantly impact the development of life-changing therapies.
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📌 Senior Principal Medical Writer - CMC (Manitoba)
🏢 Jobgether
📍 Manitoba