Criterion Edge

Content Writer

• Provide consistent, expert scientific oversight on all assigned projects.
• Collaborate with the Resourcing team to assign appropriate writing resources to each project.
• Oversee initial scoping of new projects and attend project kick-off meetings.
• Review regulatory documents and responses to regulatory authorities, specifically working on Performance Evaluation Reports (PERs).
• Conduct high level review and provide feedback to project team.
• Review/oversee the systematic literature review process (e.g. screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for IVDs.
• Provide input into company process development and improvement.
• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates.
• Coach all project-related activities to ensure alignment with applicable regulatory requirements and Criterion Edge quality standards.

Associate Director, In Vitro Diagnostic Regulation – Writing Services