Sr Associate Clinical Finish Drug Product Global Study Planner Support

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 the global clinical supply chain priorities, regulatory requirements, and financial objectives.

Roles & Responsibilities

Accurate and timely execution

• Execute under clear priorities
• Support rushes as needed
• Participate in issue triage, corrective actions, and workload prioritization with global peers.
• Ensure timely escalation and resolution of planning, procurement, and execution risk.

Clinical Supply Chain Execution

• Execute production order conversion, stock transfer order initiation, and clinical planning cycle facilitation to ensure product supply plans are executed against appropriately
• Execute in study close out activities including material destruction.
• Provide Subject Matter Expertise to peers on complex operational processes.

Performance & Process Management

• Update procedures to keep them current, compliant and inspection ready.
• Provide input to team KPIs related to service level, execution timelines, and right first-time delivery.
• Drive root cause analysis and continuous improvement to address gaps and enhance team outcomes.
• Adopt new technologies and AI to increase team productivity performance.
• Represent the team during audits and inspections.

Cross-Functional & Global Collaboration

• Partner with planners, internal and external labeling facilities, Amgen warehouses, Logistic Service Providers and Quality.
• Work with local peers to prioritize the work to avoid a back log.

Compliance & Accurate Hand off  

• Work Right First Time to all applicable GMP/GDP and Regulatory requirements and Amgen procedures. Report risks, inconsistencies and errors.

Functional Skills

Must-Have Skills:

Demonstrated accurate and efficient handling of process execution in a complex environment   Strong problem solving and analytical skills towards driving robust decision making Good organizational and communication skills including fluency in English both in oral and written communication with the ability to clearly document and communicate relevant information. Demonstrated ability to manage assigned tasks and priorities while meeting deadlines. Ability to adapt to evolving priorities that clinical studies that are agile by nature. Hands-on knowledge of SAP or similar ERP system for material planning and management. Ability to work effectively within cross-functional teams in a regulated or structured environment. Collaborative team player with the ability to support shared objectives. Experience or exposure to working with stakeholders in other time zones. Basic understanding of performance metrics, reporting tools, or data tracking processes.

Basic Qualifications

• Bachelor’s Degree and 5+ years of supply chain, logistics, planning, or operations experience
• Master’s Degree and 5+ years of relevant experience

Preferred qualifications

• 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.