Periodic Report Specialist

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 (ieblinded, 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).
• Literature Management Process
• May assist with Literature Management activities as required

• Total experience: 59 years
• At least 23 years in Periodic report writing.
• Bachelors or Masters degree in Life Sciences or Pharmacy.