Syneos Health

Senior Principal Medical Writer at Incyte

📍 toronto, on, Canada ⏰ Full-time

Description

Elevate your career with Incyte as a Senior Principal Regulatory Medical Writer specializing in Oncology. Lead document development for regulatory submissions while ensuring ICH compliance and adherence to project timelines.

Incyte seeks a skilled Regulatory Medical Writer to facilitate oncology-focused document creation and management. You will spearhead the development of critical materials such as Clinical Study Reports and contribute in cross-functional meetings to align project goals and ensure timely deliverables. Your expertise will directly impact adherence to corporate standards in regulatory documentation.

Key Responsibilities:
• Develop global regulatory submission documents
• Oversee project timelines and team communication
• Provide input in cross-functional meetings for deliverables
• Review documents for regulatory compliance
• eCTD submission experience is advantageous

Requirements:
• In-depth kn...
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