Sr Associate Clinical Supply Chain Support Office

Amgen; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Amgen is seeking a Sr Associate to support the Design and Setup of their Clinical Supply Chain based in Hyderabad. The role involves coordinating and executing setup activities for global supply chains in clinical trials while ensuring compliance and effective communication.

Qualified candidates should have at least 5 years of experience, a Bachelor’s degree in a relevant field, and proficiency in SAP and MS Office. Knowledge of clinical supply chain management is preferred.

Qualifications

• 5 years of experience in a relevant field.
• Relevant experience in the biotechnology or pharmaceutical industry.
• Understanding of logistics/supply chain principles.

Responsibilities

• Support design and setup of the Clinical Supply Chain.
• Ensure compliant process execution and reporting.
• Coordinate and prioritize artwork creation process.

Skills

Supply Chain Management

Logistics

Project Management

MS Office (Word, Excel)

English Communication

Education

Bachelor's degree in logistics, business administration or life science

Tools

SAP

Job description

In this vital role, you will serve as Sr Associate, supporting the Design and Setup of the Clinical Supply Chain.

Reporting to the Manager Clinical Supply Chain-Change Mgt, and directed by the Global Setup Leads, you will contribute to the execution and completion of key deliverables associated with setup activities of global supply chains for clinical trials, by leading information gathering across stakeholders such as R&D, Regulatory Affairs, Site Supply Chain and Master data, and task close out.

In close collaboration with the Global Setup Lead team, you will ensure reliable, compliant, and right-first-time process execution, transparent status reporting on progress, and pro-active identification of risks and mitigation strategies for closing out deliverables.

Deliverables

• Master data requests for product materials, Bill of Materials (BOM), and study related attributes in SAP.
• Creation of the Clinical Artwork requests and facilitating prioritization of outstanding attributes in relation to the request form.
• Creation and maintenance of Product Specification Files, and Depot Plans.

Roles & Responsibilities

Master Data in ERP (SAP)

• Central focus point for ERP (SAP) readiness.
• Initiate clinical label material requests.
• Request Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensure timely availability to adhere to overall project timelines.
• Ensure setup of Study Design Tables.

Setup Activities

• Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries.
• Create and maintain Product Specification File Study throughout the life cycle of the clinical trial.
• Create and maintain third-party depot plans and cross-docks to support global study footprint.

Reporting

• Maintain metrics for Global Setup lead team.
• Contribute to monthly workforce planning cycle.

Qualifications

• 5 years of experience with Bachelor degree or equivalent in logistics, business administration or life science.
• Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry.
• Typically relevant working experience in an international and regulated environment.
• Understanding of fundamentals of logistics/supply chain principles (especially BOM).
• Experience in planning.
• Experience in project management techniques.
• Advanced experience in MS Office applications (Word, Excel).
• Fluency in English, both oral and written communication.
• High quality standards with regards to work.
• Ability to set priorities and timely escalation.

Preferred Requirements

• Knowledge of clinical supply chain management.
• General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, ICH guidelines, Clinical Trial Directive).
• Experience in using SAP.
• Excellent communicating and facilitating issue resolution skills.