Job Description
Drive the regulatory writing efforts at Incyte as a Principal Medical Writer focusing on Oncology submissions. Create essential documents like Clinical Study Reports and Safety Summaries, adhering to global guidelines and timelines.
Incyte seeks a Principal Medical Writer to lead the development of regulatory documents crucial for submissions to agencies worldwide. The candidate will manage medical writing projects, ensure timely delivery, and collaborate closely with cross-functional teams. A strong understanding of ICH guidelines and eCTD submissions is preferred for this role.
Key Responsibilities:
• Develop Regulatory Submission Docs in compliance with global standards
• Manage timelines and communicate with cross-functional teams
• Participate in meetings to discuss writing deliverables and expectations
• Review related project documents like Protocols and Analysis Plans
• Ensure adherence to Incyte authoring standards across projects
Requirements:
• Pro...
Incyte seeks a Principal Medical Writer to lead the development of regulatory documents crucial for submissions to agencies worldwide. The candidate will manage medical writing projects, ensure timely delivery, and collaborate closely with cross-functional teams. A strong understanding of ICH guidelines and eCTD submissions is preferred for this role.
Key Responsibilities:
• Develop Regulatory Submission Docs in compliance with global standards
• Manage timelines and communicate with cross-functional teams
• Participate in meetings to discuss writing deliverables and expectations
• Review related project documents like Protocols and Analysis Plans
• Ensure adherence to Incyte authoring standards across projects
Requirements:
• Pro...