Senior Medical Writer for Regulatory Submissions

Drive impactful regulatory submissions as a Senior Principal Medical Writer with Incyte. Your expertise in developing documents for global regulatory agencies will be crucial to our Oncology initiatives.

Incyte is seeking a Senior Principal Medical Writer with a focus on regulatory submissions. You will create vital documents including Clinical Study Reports and Clinical Summaries while managing timelines effectively. Your role will involve collaboration across teams to ensure quality and compliance in accordance with ICH guidelines and Incyte standards.

Key Responsibilities:
• Develop precise regulatory documents for global agencies
• Manage medical writing projects and related timelines
• Engage in cross-functional meetings for deliverable input
• Review associated documents like Protocols and Statistical Plans
• Leverage eCTD submission experience for documentation

Requirements:
• Extensive experience in medi...