Global Scientific Communications

Description:

Scientific data and information are core assets of the company. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to the organisation.

The purpose of the Scientific Communications Associate - Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).

1.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 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.