Senior Principal Medical Writer Regulatory - Oncology - Single Sponsor

About This Role

Develop and manage regulatory documents for global agency submission in the oncology field, ensuring compliance with ICH guidelines and corporate objectives. This role involves leading projects, participating in cross-functional meetings, and mentoring junior medical writing staff.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes
• Manage medical writing projects, including developing timelines and communicating with cross-functional team members
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes
• Review other documents associated with assigned projects (e.g., Protocols and Statistical Analysis Plans)
• Participate in cross-functional process improvement initiatives
• Participate in defining and writing standard operating procedures and best practices
• Manage internal and contract medical writing resources to ensure timely completion of assigned projects
• Mentor more junior medical writing staff

Benefits