Supply Chain Study Manager
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige Are you ready to design, plan and manage trial medication for patients taking part in AstraZeneca clinical studies all over the world? Do you want to work in a vibrant team culture with continuous improvement and effective collaborations? Then you might be the Supply Chain Study Manager we are looking for! The consulting assignment will start 2018-05-01 and go on to 2019-08-31.
about the consultant assignment
The Arena:
As a Supply Chain Study Manager in Supply Chain/Pharm Dev, you'll develop a broad knowledge of the diverse range of clinical study options utilised by the pharmaceutical industry, as well as in-depth expertise in specific therapeutic areas. We'll look to you to design, plan and manage trial medication for patients taking part in AstraZeneca clinical studies all over the world. In return, you'll find a vibrant team culture in which continuous improvement and effective collaboration are high priorities.
The Role:
The Supply Chain Study Manager (SCSM) role is a key leadership role within R&D Supply Chain. The role holder will manage the supply chain for a portfolio of global clinical studies across all phases within a drug development programme. He / she will lead cross-functional Study Drug Working Group (SDWG) and represent these teams on the R&D Supply Chain Team. The SCSM works in collaboration with customer functions to influence and manage demand for individual studies, and is responsible for their supply chain deliverables.
The Supply Chain Study Manager role covers the full spectrum of the clinical study lifespan, across all phases of the drug development lifecycle, covering small and large molecule drug Products. Within this role the SCSM will collaborate with members of R&D SC, Clinical Development and external partners.
Within this role the SCSM will:
• Lead and provide direction to Study Drug Working Groups (SDWGs) comprising members of R&D SC, Clinical Development and external partners. Ensures the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply with expert input and support from cross functional groups.
• Understand and translate clinical study protocol requirements into demand for drug product within a clinical study. Author the drug supply section of Clinical Study Protocol and lead development of master label text.
• Use simulation tools and supply chain expertise to design optimised, lean supply chains for individual studies and ensure delivery of the end to end supply of materials to meet study needs. Define IVRS user requirements, set up IVRS tool and ensure timely go-live for individual studies. Use IVRS to track recruitment and adjust IVRS parameters to accommodate any changes in study scope and design.
• Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract. Review changes to the contract with CRO partners and Sourcing Managers as necessary.
• Monitor the budget for individual study supply activities and materials for the project. Flag deviations to SC Programme Manager. Manage change in demand and supply, resolve issues, escalating when appropriate.
• Work within GMP Quality Management Systems, including managing deviations, complaints, change controls as appropriate.
Who you are
Preferred experience/requirements:
The ideal candidate for this role will have an R&D background and strong ability to manage their time effectively, working on several studies or tasks within studies alongside each other and prioritizing between them as needed. They will thrive in a fast paced role where there is often change to the studies, using effective evaluation and analysis of complex data sets to make decisions throughout the life of the studies. They will manage business and supplier relationships well and be able to influence others cross functionally and globally.
Minimum experience:
• A suitable degree, qualification or experience in a supply chain drug development discipline. e.g. Pharmacist.
• Experience in managing and influencing customer demands.
• In depth knowledge of Clinical Development processes relevant to the supply of clinical materials.
• Experience of project management.
• Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
• Risk identification and management.
• Excellent written and verbal communication skills in Swedish and English.
About Poolia & AstraZeneca
Poolia take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment. As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Next step, apply today!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-03-14ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-03-29
Ange följande referens när du ansöker: 49748
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4020643
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