Opportunity Description
Lead regulatory document development as a Senior Principal Regulatory Medical Writer specializing in Oncology at Incyte in Toronto, ON. Apply your expertise in creating compliant submissions for global regulatory agencies.
Incyte seeks a Senior Principal Regulatory Medical Writer to develop vital regulatory documents, including Clinical Study Reports and Clinical Summaries, ensuring adherence to ICH guidelines and Incyte standards. This role requires managing writing projects and timelines while collaborating with cross-functional teams to align on expectations and review cycles.
Key Responsibilities:
• Develop regulatory submissions for global agencies
• Manage timelines and communication for writing projects
• Participate in cross-functional meetings for deliverables
• Review associated project documents as needed
• Utilize eCTD submission experience for efficiency
Requirements:
• Extensive experience in regulatory writing in oncology
• Comprehensive kno...
Incyte seeks a Senior Principal Regulatory Medical Writer to develop vital regulatory documents, including Clinical Study Reports and Clinical Summaries, ensuring adherence to ICH guidelines and Incyte standards. This role requires managing writing projects and timelines while collaborating with cross-functional teams to align on expectations and review cycles.
Key Responsibilities:
• Develop regulatory submissions for global agencies
• Manage timelines and communication for writing projects
• Participate in cross-functional meetings for deliverables
• Review associated project documents as needed
• Utilize eCTD submission experience for efficiency
Requirements:
• Extensive experience in regulatory writing in oncology
• Comprehensive kno...
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