Compliance Specialist
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!!
Human Biological Samples (HBS) are fundamental to medical research in the discovery, development and implementation of new treatments and diagnostics. HBS are ethically sensitive materials and the collection, handling and access to HBS are subject to strict regulations, principles and ethical guidelines.
The Biobank manages & maintains a data repository with appropriate human subject protection and industry best practices. The Biobank stores HBS, banked or prospectively collected from geographically diverse populations. The Compliance Specialist will co-ordinate projects and assist in delivery of projects under the supervision of the Compliance manager. The Compliance Specialist will prominently review consent forms for compliance and work with stakeholder to support compliant use of donated samples.
Key Responsibilities:
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Assist the Biobank lead and team in linking samples to consent forms.
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Review consent forms for use restriction & storage information.
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Electronically manage consent form data transfer, track & monitor project status.
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Assist the Biobank lead in identifying & managing sample sharing between teams.
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Work with the Biobanks to optimize processes around Biobank requirements for compliance.
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Work with various Biobanks to ensure sample compliance.
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Participate & contribute to team meeting & discussions.
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Support team members in delivering the Departmental goals.
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Work with the Biobank lead to ensure that learning from HBS related issues are identified and analyzed to enable continuous process improvement.
Essential
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Bachelors Degree level education
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Knowledge and understanding of compliance function, health care regulations, laws and standards related to cell therapies
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Minimum 6 months experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
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Excellent analytical, written and oral communications skills
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Demonstrable team working skills
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Ability to work independently
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Project management experience and skills
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High ethical standards, willingness to challenge inappropriate proposals/actions of senior leaders
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Strong collaborative, partnering, and interpersonal skills
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Willingness to take decisions.
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Fluent in English as the AstraZeneca working language
Desirable
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Knowledge and understanding of compliance function, health care regulations, laws and standards
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Experience in pharmaceuticals or a related industry
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Direct experience of working with HBS
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Experienced of working with multiple stakeholders
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Previous experience as a process owner and process improvement
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Experience in collection and use of HBS as part of ongoing clinical trials
Why AstraZeneca?
At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there's no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It's our purpose that drives us, every day. 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. We will go through the applications continuously so please apply as soon as possible. Welcome with your application!
Where can I find out more?
Follow AstraZeneca on LinkedIn
https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook
https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram
https://www.instagram.com/astrazeneca_careers/?hl=en Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-02-28
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-158480".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
nadja.bergman@astrazeneca.com Jobbnummer 7421430
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