Sr Mgr GRAAS Operations (Case Mgmt, Vendor Oversight) Job in Thousand Oaks, California US
Sr Mgr GRAAS Operations (Case Mgmt, Vendor Oversight)
The purpose of this group is to support the safety surveillance process for Amgen products by overseeing one or multiple key vendors responsible for the processing of individual case reports. - Ensure vendor compliance with the approved processes and training requirements - Oversee all ICSR processing globally for clinical trial and post-market cases - Lead/Single point of accountability for managing one or more key vendor relationships for ICSR processing. Job Summary / Responsibilities: - Vendor delivers high quality cases in a timely manner to meet all worldwide regulatory authority requirements - Assigned vendor(s) relationship and successful issue management - Support budget projections and keeping within approved budget for assigned vendors - Provide assigned vendor(s) with resources and training to perform their role - Support development and maintenance of SOW and contracts - Audit and external inspection support - Assigned staff within the Vendor Oversight function as direct and indirect reports. Key Activities: - Support management of budget projections and monitor spend for assigned vendor - Day-to-day issues management for assigned vendor - Support generation of SOW content - Ensure on-boarding and on-going training of assigned vendor - Ensure reference document provision to assigned vendor - Attend management meetings with assigned vendor - Effective interaction with GSS/SPM for assigned vendor - Oversee performance monitoring and relay metrics to assigned vendor - Communicate datalocks and timelines to assigned vendor - Oversee workload management for assigned vendor - Support vendor audits/inspections - Evaluates development strategy impact on target product labeling - Identifies and analyzes regulatory requirements and competitive labeling - Support other case processing functions as required