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.
Requirements
Having 2 to 5 Years of experience into Protocol Writing