Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management

• Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
• Regulatory writing experience - Clinical study reports, IBs, protocols, protocol amendments, CTD modules, etc.
• Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
• Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
• Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
• Ensure data are presented in a clear, complete, accurate, and concise manner.
• Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
• Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
• Ensure and coordinate quality checks for accuracy.
• Exhibit flexibility in moving across development and preparation of multiple document types.
• Influence or negotiate change of timelines and content with other team members.
• Work with internal and external experts to develop and prepare presentations.
• As needed, may build and manage relationships with vendors/alliance partners.