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.
- 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 transparent, 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.
Project and Stakeholder management
- Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.
- Build/communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery.
- Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
- Effectively communicate project status to