Clinical Supply Strategist Latam/sr. Analyst

hace 2 meses

Buenos Aires, Argentina Pfizer A tiempo completo

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 the identification of key opportunities, strategies and goals to facilitate trials conduction for clinical supplies in LATAM region.

Enable Global Clinical Supply and Pfizer partners to meet patients’ needs in the region.

The role will 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.

Clinical Supply Strategy & Management (CSSM)

Support clinical supply strategic plans, including product demand and customized studies designs, to ensure timely delivery and resource optimization for Clinical Trials and Early Access programs conducted in the region (e.g., Compassionate, Expanded & Post-Trial Access programs).

Why Patients Need You

Our manufacturing logistics and supply team makes sure that customers and patients have the medicines they need, when they need them. You will help bring medicines to the world even faster by embracing challenges, imagining what’s possible and taking action.

What You Will Achieve

You will help Pfizer carry out the activities in distribution logistics centers to meet customer requirements, such as shipping and receiving requests, packing, storage, distribution of products, samples and promotional literature to domestic and/or international locations and associated customer service. Your will be responsible for preparing and/or supplying clinical supplies used in clinical trials in compliance withGoodManufacturingPractice (GMP) regulations, which typically include packaging, labelling, assembling, shipping, records maintenance, protocol evaluation, coding of samples and storage of approved materials.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will help us find solutions to develop breakthroughs that will change patients’ lives.

How You Will Achieve It- 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 couri

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