Company
Life Sciences
SrAssociateClinicalFinishDrugProductGlobalStudyPlannerSupport
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr Associate Clinical Finish Drug Product Global Study Planner Support. Skills: Clinical supply chain, Process execution, Stakeholder management. Support execution of clinical planning processes. Ensure execution of activities for Finished Drug Product”
What You'll Achieve.
Ensure supply for patients; Ensure product supply plans are executed; Enhance team outcomes
Industry & Context.
Problem solving; Analytical skills; Issue triage; Corrective actions; Risk mitigation; Root cause analysis
What They're Looking For.
Must Have
Bachelor’s Degree and 5+ years of supply chain, logistics, planning, or operations experience, Master’s Degree and 5+ years of relevant experience, Demonstrated accurate and efficient handling of process execution, Problem solving and analytical skills, Good organizational and communication skills, Fluency in English both in oral and written communication, Demonstrated ability to manage assigned tasks and priorities, Ability to adapt to evolving priorities, Hands-on knowledge of SAP or similar ERP system, Ability to work effectively within cross-functional teams, Collaborative team player, Experience or exposure to working with stakeholders in other time zones, Basic understanding of performance metrics, reporting tools, or data tracking processes, Work Right First Time to all applicable GMP/GDP and Amgen procedures
Nice to Have
Experience with document workflows in Veeva Vault, Experience in regulated manufacturing or life sciences industry, Exposure to change initiatives, system implementations, or continuous improvement efforts, APICS or Lean/Six Sigma certification
What You'll Do.
Support execution of clinical planning processes
Ensure execution of activities for Finished Drug Product
Handle requests for new labeling jobs in ERP
Initiate and follow up stock transfer orders in
Initiate destruction of finish drug product
Follow up on destruction delays or discrepancies
Perform periodic checks
Route controlled documents
Update text after review workflow
Execute complex supply chain processes
timely and GMP compliant execution
Provide operational oversight across supply planning
Provide operational oversight across order management
Provide operational oversight across material destruction
Indicate problems and inconsistencies
Support Global Study Planners
Manage workload prioritization
Participate in performance management
Participate in risk mitigation
Participate in continuous improvement initiatives
Execute under clear priorities
Support rushes as needed
Participate in issue triage
Participate in corrective actions
Ensure timely escalation of planning risk
Ensure timely escalation of procurement risk
Ensure timely escalation of execution risk
Ensure timely resolution of planning risk
Ensure timely resolution of procurement risk
Ensure timely resolution of execution risk
Execute production order conversion
Execute stock transfer order initiation
Execute clinical planning cycle facilitation
Execute in study close out activities
Execute material destruction
Provide Subject Matter Expertise to peers
Update procedures to keep them current
Update procedures to keep them compliant
Update procedures to keep them inspection ready
Provide input to team KPIs
Drive root cause analysis
Drive continuous improvement to address gaps
Drive continuous improvement to enhance team outcomes
Adopt new technologies
Adopt AI to increase team productivity
Represent the team during audits
Represent the team during inspections
Partner with planners
Partner with internal labeling facilities
Partner with external labeling facilities
Partner with Amgen warehouses
Partner with Logistic Service Providers
Prioritize the work to avoid a back log
Report inconsistencies
How You'll Work.
Team & Collaboration
Global Study Planners; Internal customers; External customers; Local team members; Global peers; Planners; Labeling facilities; Amgen warehouses; Logistic Service Providers; Quality
Communication Scope
Oral communication; Written communication; Documenting information; Communicating information
Process & Methodology
Risk mitigation, Continuous improvement
Full Job Description
## **Career Category** Supply Chain ## ## **Job Description** ## Role Description Let’s do this. Let’s change the world. In this vital role, you will serve as lynchpin between Global Study Planners and internal and external customers to ensure supply for our important patients participating in Amgen’s global clinical trials. Along with local team members, you support the execution of clinical planning processes and ensure the execution of activities so that Finished Drug Product is available from study start throughout study closure. You closely interact with Global Study Planners in Europe and USA. Reporting to the Manager Clinical Finish Drug Product and Comparator Supply, you support the global execution of clinical planning processes. While the Global Study Planner decides the need for sufficient inventory and timely destruction, you execute on these requests. Each day you handle the requests for new labeling jobs in ERP based on the system signals. Another task is to initiate and follow up stock transfer orders in ERP in close conjunction with the planner’s information for quantity, timing and destination. You initiate the destruction of finish drug product and follow up in case of delays or discrepancies. You are also responsible for several periodic checks and give input to KPI’s. You route controlled documents and update text after review workflow in conjunction with the subject matter expert. The role is accountable for executing complex supply chain processes, accurate, timely and GMP compliant execution and follow up. You provide operational oversight across supply planning, order management, material destruction and indicate problems and inconsistencies. In close collaboration with your local peers, you give support to the Global Study Planners based in other parts of the world. You manage workload prioritization and participate in performance management, risk mitigation, and continuous improvement initiatives across the teams, ensuring alignment with th
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