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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
Position Purpose
Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA.The incumbent will partner with various colleagues from Safety, Clinical, Regulatory and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance.Primary Responsibilities
Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc.Review data to ensure consistency between various contributors.Compile the information for reports using various electronic tools and document management system.Coordinate the review and approval of the report and address review comments.Ensure reports are completed prior to regulatory due date to meet compliance.Provid...