Supply Chain Associate – Clinical Operations

Job Qualifications:

• BA/BS in supply chain, scientific, computer science or business field with at least 2 years’ experience in pharmaceutical industry and/or supply chain management.

• Knowledge and experience working in a Good Manufacturing Practices (GMP) / Good Clinical Practices (GCP) environment.

• Adaptable to non-standard work schedule or environment requirements.

  • May require periodic attendance at team meetings across time zones and occasional after-hours support, particularly on software release dates.

Skills

• Must be proficient in Microsoft Office programs.
• Comfortable preparing and presenting ideas and information in a variety of settings.
• Knowledgeable about Clinical Supply Packaging and/or labelling and/or Distribution (e.g. technical, process, plan or system).
• Articulate in both verbal and written communication.
• Excellent customer focused communication and listening skills.
• Proven interpersonal, facilitation, customer relations and negotiation skills.
• Demonstrated ability to learn fast and foster a culture of innovation.
• Possess strong analytical and problem-solving abilities, with a proven capacity to work collaboratively with colleagues and customers in a matrix environment.

Job Responsibilities:

The role of the Clinical Supply Support Associate (CSSA) – Clinical Supply Operations (CSO) is to provide support for Clinical Supply Operations (CSO) in the areas related to the receipt, packaging, labeling, warehouse, distribution and logistics (P/L/D) operations of clinical supplies. They will also provide support in document management, metrics, order request and completion and other items required to support this area. The position also requires providing support across different global time zones.

• Support the implementation of operational strategies for effective and efficient execution of P/L/D operations.
• Execute P/L/D operations ensuring quality, regulatory compliance, and exemplary customer service. Apply project management skills to strategically plan, implement, and assess risks to ensure operational success, and exercise sound judgment when resolving basic issues from limited alternatives, maintaining minimal or no impact on P/L/D outcomes.
• Leverage knowledge of supply chain processes and systems to assist in implementing operational strategies that enable the effective and efficient execution of P/L/D operations, including managing receipt processes to ensure accurate documentation and timely reconciliation of all incoming goods and materials.
• Maintain systems and documentation for P/L/D operations.
• Liaise with internal stakeholders, including, but not limited to Operational Strategy Leads (OSLs), CSO Planners and Schedulers, and Label Operations to support and execute P/L/D operations using technology and supply chain systems.
• Utilize CSO enterprise systems (e.g., EMD365, CSDS, Clementine, Prisym360) to perform P/L/D operations.
• Ensure timely completion of system-related tasks for assigned P/L/D jobs.
• Design clinical labels in the label system/software based on requirements and procedures.
• Support CSO operational compliance and inspection readiness.
• Ensure all P/L/D activities comply with regulatory requirements and quality standards.
• Manage receipts and shipment tracking.
• Prepare reports on P/L/D activities and performance and maintain accurate records & documentation.
• Provide occasional coverage for team members on high-priority activities and studies.