Manager, CSO Planning & Production Solution

ROLE SUMMARY

• Clinical Supply Operations (CSO) is part of Clinical Development and Operations (CD&O) Global Clinical Supply (GCS) Group.  Our purpose is to provide packaging, labeling, and logistics solutions to deliver quality patient-focused clinical supplies to the patient.  We provide quality clinical supplies in a compliant, timely, innovative and cost-effective manner.  We continuously strive to improve our systems, processes and capabilities in collaboration with our Pfizer and external partners in support of developing breakthroughs to change patients’ lives. 

• The Planning & Production Solution Manager is responsible for providing label and system support (e.g., Prysim360, CTAI, etc.) in execution of packaging, labeling, and distribution (P/L/D) operations to ensure effective execution and completion of label design and production and P/L/D operations and timely delivery of clinical supplies to support clinical studies and patients.

• An essential component of the role is to utilize knowledge of Supply Chain process and enterprise supply chain systems knowledge and skills to design, initiate, approve and produce labels intended for clinical trial supplies in accordance with Good Manufacturing Practices (GMP) and to implement operational strategies that enable effective and efficient execution of P/L/D operations.  The Planning & Production Solution Manager is the subject matter expert for CSO operations and is accountable for improvement and execution of CSO operations activities.

• This position also works closely with Operational Strategy Leads (OSLs), Planning Leads, and other key functional roles in CSO and GCS and Vendors to utilize technology and industry trend information to proactively contribute to improving effectiveness of CSO supply chain labels and systems. 

• The position requires a quality and customer focused individual with continuous improvement mindset and technical/ operational acumen to work with all business partners to take effective actions to ensure inspection readiness and obtain and retain knowledge of new capabilities across our vendor network to ensure sustained and continuous enhancement of system knowledge and skills.

ROLE RESPONSIBILITIES

• Responsible for working with others in Global Clinical Supply (GCS) or vendors to understand the label design requirements for a clinical study and execute P/L/D transactional tasks in CSO supply chain systems and enable timely delivery of clinical supplies to support clinical studies and patients.

• Apply systems technical expertise to execute P/L/D tasks across the spectrum of CSO enterprise systems to ensure high quality clinical supplies (e.g. EMD365, CSDS, Clementine, Prisym360 and others).

• Serve as a subject matter expert in PRISYM360 and other labeling systems, executing tasks and providing end‑to‑end oversight of label design, approval, printing, re‑printing, inspection, and inventory management, ensuring compliance with Label Request documents and country‑specific regulatory requirements.

• Generate and approve label designs, reports, and print requests for use by internal operations and external labeling vendors and to support Trial Master File documentation.

• Support Phrase Library administration, metrics, and operational reporting to ensure accuracy, consistency, and inspection readiness.

• Evaluate current processes on an on-going basis and make recommendations/implement for continuous improvement in the P/L/D enterprise systems and associated operating model.

• Accountable for the timely completion of system-related tasks for the assigned P/L/D jobs.

• Participate in CSO operational compliance and inspection readiness.

• Provide support to complex P/L/D projects to ensure successful project deliverables.

• Support the implementation of new global standards and technologies which support the identity of our clinical trial supplies throughout CSO supply chain enterprise systems.

• Support the execution of P/L/D workload to ensure quality and compliance utilizing project management skills to plan, execute and assess risks to complete the job.

• Contribute to the ideas in line with Pfizer Purpose Blueprint and AI initiatives and develop tactical solutions to enable long term strategic objectives.

• Build strong collaborative relationships with internal and external partners (e.g., CSSM, PSOQ, vendors) and vendor network, identify and implement process improvements and innovative solutions, and lead contin