Regional External Commercial Products

2 semanas atrás

São Paulo, São Paulo, Brasil AstraZeneca Tempo inteiro

Regional External Commercial Products (ECP) Lead - Americas
Brazil

Make a meaningful impact on people's lives with life-changing medicines


External Commercial Products (ECP) are critical to late stage clinical trials primarily to support or compare new therapy with current practise.

The variability, complexity and increased cost of current therapies across the world makes supply chain design and optimisation complex, with a combination of central and local sourcing of ECP needed.


We are now looking at strengthening our capability in, and support of local sourcing through establishing clear and aligned standards, processes and responsibilities which will improve organisational efficiency, compliance, cost and risk to projects.


The Clinical Manufacture and Supply organisation is accountable for planning, orchestrating and production of all clinical supplies of packed and labelled investigational products to early phase clinical studies of small/synthetic molecules and all late phase clinical studies across all modalities, unless they are locally sourced ECPs.

We are a clinical supply organisation of ca 400 people across 5 countries (UK, SE, PL, US and CH), who are passionate about delivering to our patients and making the most of the supplies we have available - where every pack counts

What you'll do:


Act as Subject Matter Expert (SME) for local sourcing activities related to External Commercial Products (ECP)s within a specific region, ie cluster of countries.


Be part of a small global network of Regional ECP leads to develop enterprise wide processes and minimum standards for local sourcing, in collaboration with experts in other fields such as Quality, Procurement and Regulatory.

Business Process Owner for local ECP sourcing within the region.

Standards and business processes will primarily address vendor selection and oversight, supply chain approaches (plan and monitor demand and supply), quality requirements (GMP and GDP) and cost and waste management.

Work closely with the relevant leads/teams in each local market within the relevant region to understand current local practice.

Help implement and train current best local practice and design and develop future local or regional practice with a strong focus on what is best for the enterprise as a whole.

Act as a single point of contact for relevant local leads/teams for support and queries.


Develop processes for monitoring and measuring the performance in their region in relation to quality/compliance, supply volume and risk, cost/waste of material and resource utilization.

Own and manage any change process related to local ECP sourcing within the region. Engage with partners across the business to clarify/simplify processes and gain commitment for alignment across functional boundaries.

Demonstrate excellent communication, influencing and collaboration skills required to interact with a multitude of stakeholders across functional boundaries across the business (eg Regulatory, Site Monitoring and Management (SMM), Clinical Operations, Development Quality and Clinical Quality, Procurement)

Essential Skills & Experience

  • Educated to Degree level (or equivalent experience)
  • Knowledge and experience of supply chain principles, eg demand and supply planning.
  • Knowledge and experience of GXP Standards within both Clinical and Supply Chain environment (GMP, GDP and GCP).
  • In depth knowledge and experience of Clinical Development/Operations organisation and processes relevant to Investigational Medicinal Products and Auxiliary Medicinal Products
  • In depth experience and evidence of project management, change management, managing business partner expectations and relationships.
  • Enterprise thinking and process management
  • Evidence of strong influencing, negotiating and problem solving skills across functional, geographical, cultural boundaries.
  • Excellent communication in English


Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational and Auxiliary Medicinal Products would be desirable but not essential.

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We're on an exciting journey to pioneer the future of healthcare.

What's next...
Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you

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