Medical writer

• Develop regulatory documents for submission to regulatory agencies globally, following ICH and other global guidelines, standards, processes, and client authoring standards
• Adhere to study/project timelines and corporate objectives
• Manage medical writing projects, including developing timelines and communicating with cross-functional team members about review cycles and expectations
• Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes
• Review associated project documents such as protocols and statistical analysis plans
• Participate in cross-functional process improvement initiatives
• Help define and write standard operating procedures and best practices for efficient preparation of quality documents
• Manage internal and contract medical writing resources as required
• Mentor more junior medical writing staff

Explore Senior Principal Medical Writer – Regulatory Submission Docs,… at Syneos Health. Review requirements and application details.

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