Supply Chain Study Manager to AstraZeneca in Gothenburg

We are now looking for a Supply Chain Study Manager for a long term consultant assignment at AstraZeneca in Gothenburg. With the right profile and a lot of passion, this might be the start of a fruitful and developing employment at Pema Engineering & Science.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The Role

The Supply Chain Study Manager (SCSM) role is a key role within R&D Supply Chain. The role holder will manage and coordinate the drug 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 members of R&D SC, Clinical Development and external partners to manage drug demand for individual studies and is responsible for the drug supply deliverables.

SCSM responsibilities

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Lead and provide direction to Study Drug Working Groups (SDWGs) comprising members of R&D SC, Clinical Development and external partners. 

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Ensures the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply with expert input and support from cross functional groups.

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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.

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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. 

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Use IVRS to track recruitment and adjust IVRS parameters to accommodate any changes in study scope and design.

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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.

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Monitor the budget for individual study supply activities and materials for the project. Manage change in demand and supply, resolve issues, escalating when appropriate.

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Work within GMP Quality Management Systems, including managing deviations, complaints, change controls as appropriate

Preferred experience/requirements

The ideal candidate for this role will have an R&D background and strong ability to manage their time effectively, coordinating several studies or tasks within studies alongside each other and prioritizing between them as needed. He/she 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.
• 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.

 

Are you the perfect match?

If you have any questions regarding the assignment, please contact Business Area Manager, Karin Lyckemalm at karin.lyckemalm@pemapeople.se or 0720-808934

You apply by register below and attach CV and cover letter.

Last applicxation day is 2016-11-09, however selection is done continuously.

We are looking forward to receiving your application!

 

Pema People AB is staffing and recruitment Company that has been active since 1997. Pema People AB is a company in constant development and since 2016 we are presented in Gothenburg. We match the best people to interesting companies and assignments. We offer our employees maximum experience in short time.

Pema Engineering & Science has extensive experience from both staffing and science. You can feel Confident in that we understand your business and the challenges you may face. We offer our staff a unique and solid employment solution, which forms the basis for a long-term cooperation.