Job description
Pharmaceutical Technology and Development (PT&D) is the bridge which turns forward-thinking science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.Clinical Manufacturing & Supply (CM&S) is accountable for the supply of medicines to AstraZeneca’s clinical trials. The use of Interactive Response Technology (IRT) allows automated inventory management to maintain the right kits, for the right patients, at the right time, in the right place. For each study, Clinical Operations and the Therapeutic Areas (TA’s) within CM&S collaborate closely to build specific IRT requirements which are then configured and validated by the IRT vendor.IRT is a critical and strategic business application that directly impacts the speed, quality and cost of AZ’s clinical studies. Frequently, configuration / validation activities are on the critical path for study start up. What you’ll doThe IRT Specialist will act as expert representing the TA Areas in IRT set-up and change management:We need you to liaise with Clinical Supply Study Leads (CSSLs) converting supply chain design to IRT user/business requirements, attending as the TA area representative in IRT meetingsProvide risk assessment activity to determine UAT requirements for new set-ups or changesAuthor/approve test scripts as the need arisesIn addition, as part of a wider IRT Specialist Network, contribute to:Establishing standard methodology and ensure issues and learnings are shared both locally and globallyDevelop and continuously improve IRT processes, SOPs, procedures, and training materials associated with IRT
Responsibilities & skills
The Supply Chain IRT Specialist will work closely with other roles in the Therapeutic Area organizations e.g. the Clinical Study Supply Leads and the Study Design Specialist.
Education
In depth knowledge of Global Clinical Supply Chain and drug development process.In depth knowledge of Clinical Development processes relevant to investigational products.Demand planning and forecasting experience.
Experience
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AstraZeneca Uk
A global pharmaceutical company with a major UK presence. Our purpose is to push the boundaries of science to deliver life-changing medicines. The best way we can help patients is to be science-led and share this passion with the scientific, healthcare and business communities of the UK.
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