MSD Malaysia
Senior Specialist, Clinical Supplies Project Manager – Inventory Manager (Hybr
MSD Malaysia, Rahway, New Jersey, us, 07065
Senior Specialist, Clinical Supplies Project Manager – Inventory Manager (Hybrid)Job Description
The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company's Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.
This role works within the Planning Execution and Inventory Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical supplies for their assigned studies. The primary function of the IM CSPM is planning the availability of materials and subsequent movement through our depot network and further through to distribution and management of materials to the clinical site. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product.
Primary activities include, but are not limited to:
Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
Interacts with key partners in both GCS (Logistics and Trade, Distribution, Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.
Responsible and accountable for establishing the timelines for clinical supply needs per protocol and ensuring a robust signal for packaging and distribution for Clinical Finished Goods (CFGs).
Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.
Responsible and accountable for utilizing key technological tools in the planning and managing of clinical supplies for assigned studies such as IRT & Microsoft PowerApps.
Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained.
Report clinical supply chain incidents to support the gathering of metrics in GCS to describe business health. Participate in root causing to identify areas for operational improvement.
Participates in critical non-pipeline activities in support of clinical supply planning group (e.g., process improvement initiatives, subject matter expert roles, cross functional projects, etc.)
Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and data.
Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work.
Focus on Customers & Patients.
Make rapid, disciplined decisions.
Demonstrates Ethics & Integrity.
Required Experience and Skills:
Bachelor’s Degree in business, supply chain management, engineering or scientific discipline required.
At least 5 years of experience in project management.
At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent.
Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation, influencing, and relationship-building skills to ensure alignment and collaboration in the supply planning process.
Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management.
Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word.
Strong Analytical & Problem Solving Skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes.
Flexibility & Adaptability: Demonstrates ability to thrive in a fast-paced and dynamic environment, with the capability to adapt quickly to changing business needs and priorities.
Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize tasks, and meet tight deadlines.
Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function.
Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems.
Proven record in project/portfolio management.
Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable.
Preferred Experience and Skills:
Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise.
Knowledge of order management, supply chain operations and document control.
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The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company's Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.
This role works within the Planning Execution and Inventory Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical supplies for their assigned studies. The primary function of the IM CSPM is planning the availability of materials and subsequent movement through our depot network and further through to distribution and management of materials to the clinical site. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product.
Primary activities include, but are not limited to:
Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
Interacts with key partners in both GCS (Logistics and Trade, Distribution, Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.
Responsible and accountable for establishing the timelines for clinical supply needs per protocol and ensuring a robust signal for packaging and distribution for Clinical Finished Goods (CFGs).
Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.
Responsible and accountable for utilizing key technological tools in the planning and managing of clinical supplies for assigned studies such as IRT & Microsoft PowerApps.
Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained.
Report clinical supply chain incidents to support the gathering of metrics in GCS to describe business health. Participate in root causing to identify areas for operational improvement.
Participates in critical non-pipeline activities in support of clinical supply planning group (e.g., process improvement initiatives, subject matter expert roles, cross functional projects, etc.)
Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and data.
Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work.
Focus on Customers & Patients.
Make rapid, disciplined decisions.
Demonstrates Ethics & Integrity.
Required Experience and Skills:
Bachelor’s Degree in business, supply chain management, engineering or scientific discipline required.
At least 5 years of experience in project management.
At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent.
Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation, influencing, and relationship-building skills to ensure alignment and collaboration in the supply planning process.
Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management.
Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word.
Strong Analytical & Problem Solving Skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes.
Flexibility & Adaptability: Demonstrates ability to thrive in a fast-paced and dynamic environment, with the capability to adapt quickly to changing business needs and priorities.
Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize tasks, and meet tight deadlines.
Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function.
Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems.
Proven record in project/portfolio management.
Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable.
Preferred Experience and Skills:
Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise.
Knowledge of order management, supply chain operations and document control.
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