Study Design Specialist
AstraZeneca AB / Kemistjobb / Göteborg
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hela Sverige At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Pharmaceutical Technology and Development (PT&D) is the bridge which turns brilliant 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.
Our global Clinical Program Supply Chain team is growing, and we are now looking for a Study Design Specialist to join our team. Maybe this is you?
What you'll do:
As a Study Design Specialist(SDS), you will develop the drug supply strategy for clinical studies. These supply chains are complex with typically high variability in demand, long lead times, technical complexity, regulatory constraints and high cost of goods. Our customer expectations are high with a focus on 100% availability of medicine to patients, speed to deliver and at a minimal cost. This complexity is likely to increase, and customer demands will remain high. You will work closely with our Clinical Supply Chain Leads, study design teams in the Science Units and Clinical Study Supply Leads to optimize the study drug supply strategy.
Your responsibilities will include:
• Collaborating with customers (eg. Global Medicines Development, Global Medical Affairs, and other PT&D and Pharm Sci functions) determine and influence drug demand.
• Work closely with CSCL to identify opportunities for optimization and provide data driven cost & risk scenarios as part of the Study Design process.
• Develop study supply strategies (kit design, manufacturing strategy, distribution strategy) for agreement with CSCL to provide a baseline for the study supply delivery.
• Ensure Supply Chain levers and considerations are inputted to protocol development and feasibility.
• Provide on-going support to CSSL to review & redesign the Study Supply Strategy in response to design and operational changes
• Be a super user & technical expert for the N-side Suite, providing coaching and training for GCSC.
• Develop tools & guidance for GCSC in study drug supply optimization.
Required Skills & Knowledge:
• Degree in supply chain related or drug development discipline or equivalent qualification or experience.
• In depth knowledge of R&D supply chain and drug development processes.
• Knowledge of pharmaceutical production, supply chain principles, good manufacturing practice, Food and Drug Administration requirements (or equivalent) and Customs rules and regulations.
• Proficient IT skills and an aptitude for systems.
• Excellent analytical skills and an interest in using data to drive decisions.
Additional Requirements:
• Demonstrated technical skills and mindset in supply chain management including demand management and supply chain design / optimization.
• Experience of supply chain optimization tools (eg N-side Suite/CT-Fast or equivalent)
• Good understanding of the principles of risk.
• Good influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
• Demonstrated experience of training and coaching colleagues
• Excellent English written and verbal communication skills.
Are you ready to make a difference? Send in your application, and we'll make it happen together.
We welcome your application no later than January 8, 2021.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2020-12-17ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2021-01-07
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-093579".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5493058
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