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:
Assist the Biobank lead and team in linking samples to consent forms.
Review consent forms for use restriction & storage information.
Electronically manage consent form data transfer, track & monitor project status.
Assist the Biobank lead in identifying & managing sample sharing between teams.
Work with the Biobanks to optimize processes around Biobank requirements for compliance.
Work with various Biobanks to ensure sample compliance.
Participate & contribute to team meeting & discussions.
Support team members in delivering the Departmental goals.
Work with the Biobank lead to ensure that learning from HBS related issues are identified and analyzed to enable continuous process improvement.
Essential:
Bachelors Degree level education
Knowledge and understanding of compliance function, health care regulations, laws and standards related to cell therapies
Minimum 6 months experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
Excellent analytical, written and oral communications skills
Demonstrable team working skills
Ability to work independently
Project management experience and skills
High ethical standards, willingness to challenge inappropriate proposals/actions of senior leaders
Strong collaborative, partnering, and interpersonal skills
Willingness to take decisions.
Fluent in English as the AstraZeneca working language
Desirable:
Knowledge and understanding of compliance function, health care regulations, laws and standards
Experience in pharmaceuticals or a related industry
Direct experience of working with HBS
Experienced of working with multiple stakeholders
Previous experience as a process owner and process improvement
Experience in collection and use of HBS as part of ongoing clinical trials
Where can I find out more?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
