Role Summary

The Clinical Supply Strategist is responsible for executing the clinical supply operational strategy across Latin America (LATAM) region for global and local studies including Investigational Product (IP) logistics (import/export).

This role will have multiple responsibilities and collaborations across main Global Clinical Supply (GCS) functional lines as Global Clinical Supplies Operations (GCSO) and Clinical Supply Strategy & Management (CSSM).

Global Clinical Supplies Operations (GCSO)

Support Global Clinical Supply regional strategic plan to R&D Clinical portfolio in alignment with Pfizer's Corporate plans.

Support the clinical supply end-to-end operations for LATAM countries, especially Argentina, from packaging to delivery to patients. Main roles will include Clinical Supply Logistics aiming to drive automation and efficiency in Import/Export, transportation, and distribution networks.

• Support clinical supply strategic plans for clinical trials and Early Access programs conducted in the region to ensure timely delivery and resource optimization.
• Deliver GCS Clinical Supply Logistics and Regional Operations activities with regards to planning, cost effectiveness and timely delivery of high-quality clinical supplies.
• Conduct the IP Import/Export operations for Clinical Trials and Early Access programs (Compassionate Access, Expanded Access, and Post-Trial Access) across LATAM, including Argentina and Mexico.
• Ensure connectivity and awareness to the entry clearance activities conducted by the preferred customs brokers across this local landscape.
• Ensure local requirements, regulations and legislations are reflected accordingly in IP operational strategies based on each LATAM country.
• Evaluate current processes on an on-going basis and make recommendations for continuous improvement with regards to the regional operations and import/export operating model.
• Support key performance indicators (KPI's) implementation and control to monitor operational performance and consistency against stated goals for logistics responsibilities in the countries for this region.
• Provide local support for Pfizer Regulatory Affairs, Clinical Development & Operations (CD&O) and external partners (CRO) in Clinical Trial Application (CTA) by being accountable for reviewing IP related documentations (drug supply description, forecast, manufacture information, etc) for quality and compliance purposes before MoH submission.
• Assist Pfizer Regulatory Affairs and/or external partners with Import License review and validation (drug supply forecast) for quality and compliance purposes, whenever needed.
• Facilitate global and local communications between main stakeholders.
• Regional partnership of strategic vendors such as couriers, brokers, local depots, domestic distribution to ensure safe and secure movement of clinical supplies to patients.
• Ensure that IP Import/Export costs are being charged accordingly. Ensure VAT is being reclaimed accordingly, when applicable.
• Execute Finance transactions for IP Import/Export operations in strategic financial systems (e.g., SAP, Kofax, etc).
• Proactively ensure quality and compliance through risk identification and mitigation plans, strategic planning and execution, and overall design input on a program and protocol basis, being supported by Clinical Supply Strategists Senior/Coordinator/Manager.
• Support regional label requirements identification for clinical supplies and comparators.
• Clarify countries nuances, requirements, timelines, costs to global and local partners/vendors to facilitate trials conduction in the region.
• Anticipate any risks or issues associated with clinical supplies operational strategies across the region.
• Support regional clinical supply demand and forecast based on protocols design.
• Active participation in global and local meetings to support IP operational strategies.
• Represent the GCS LATAM team in global projects and initiatives to provide broader perspectives and backgrounds, in addition to add diversity into discussions (e.g., Sustainability, DE&I, Digital Clinical Supply Chain, Innovation Lab, etc).

• B.S. degree (or equivalent) is required (Pharmacy preferred), with 1 to 3 years minimum of relevant experience (CRO or pharmaceutical industries preferred).
• Previous experience with clinical supply importation process and/or commercial importation process in Argentina.
• Work experience must include some of the following: drug development, clinical study design, scientific research, pharmaceutical manufacturing / packaging / labeling, cGMP requirements, leading project teams.
• Ability to speak major languages (English and Spanish) in the region to communicate with local authorities & partners, and read local documents related to clinical supplies.
• Strong verbal and written communication skills with strong internal and external relationship skills.
• Advanced Microsoft Office Suite skills and strong competency with tools.

• Clinical Research Experience (i.e., CRA/Monitoring, regulatory, clinical supply chain) preferred.
• Master's degree and relevant pharmaceutical experience.
• Knowledge of Good Manufacturing Practices (GMP).
• Demonstrated skills in analysis and problem solving.
• Ability to travel (domestic and international) up to 10% of the time; must be able to drive and/or fly to vendor locations with advance notice and/ or attend job related training, as required.
• Occasional travel to Pfizer, clinical sites, and vendor sites may be required.