Key Responsibilities:
Compilation and authoring of PASRs
• Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment
• Drive report timelines and escalate risks or delays to team leads or management
• Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template.
• Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists
• Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows.
• Maintain and archive accurate records and documentation throughout the report process.
• Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World).
• Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs)
• Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes
• Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists
• Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
• Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).