Report Coordinator, Sr. Associate

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. The individual will act as primary point of contact providing subject matter expertise to the group and various stakeholders. The individual will act as mentor to new colleagues, providing training and guidance on report coordination tasks and functions and is responsible for the preparation and maintenance of work instructions related to the respective subject matter.

Primary Responsibilities

• Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc.
• Revie...