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AstraZeneca
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Macclesfield, Cheshire
Clinical Study Supply Lead - 12 Month Secondment / Fixed Term Contract / FTO
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Job Description
Clinical Study Supply Lead - 12 Month Secondment / Fixed Term Contract / Fixed Term Opportunity Location: UK (Macclesfield) At AstraZeneca, we believe in the potential of our people and you'll develop beyond what you thought possible! We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Would you like to utilise your supply chain knowledge and skill base to lead clinical supplies for your portfolio of global clinical studies? The Clinical Study Supply Lead (CSSL) is a key role within our Clinical Manufacturing and Supply teams. This role involves running a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients. What you'll do Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply. Lead the Study Drug Working Group and contribute to the Supply Chain Team Meetings enabling continuous cross-functional dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study. Monitor the budget for your individual study supply activities and materials for the project including packaging, labelling and distribution costs. Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls. Manage the Interactive Response Technology (IRT) system to execute demand and supply planning. Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction. Ensure effective communication with project teams and key partners across a global network. Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies. Required Skills & Knowledge * Bachelors Degree in a scientific or business subject area - equivalent experience will be considered * Experience within a supply chain environment or pharmaceutical industry * Holistic knowledge of end to end supply chain activities * Experience of demand planning and forecasting * Experience in running projects and inuencing customer demands * Strong inuencing, negotiating and problem-solving skills, across geographical and cultural boundaries * Risk identification and management * Excellent English written and verbal communication skills * Proficient IT skills with an ability to adapt and operate in bespoke multiple systems Preferred Skills & Knowledge * Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice) * Knowledge of clinical development processes relevant to the supply of clinical materials * Lean knowledge and understanding * Experienced in handling Quality Events (Deviations, Change Controls, Complaints) At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey. So, what's next! Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Date Posted 04-Jun-2020 Closing Date 18-Jun-2020 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.