HBS Compliance Specialist at AstraZeneca

We are looking for a HBS Compliance Specialist at AstraZeneca in Gothenburg!

Are you ready to make an impact as a HBS Compliance Specialist? In this role you will co-ordinate projects and assist in delivery under the supervision of the Compliance associate Directors and project leads to ensure collation of all information related to HBS. The post holder will be required to work with the biobank to reconcile the HBS inventory against compliance information to allow decision making on inventory.

Purpose, Offer and Benefits

This is a 12-month consulting assignment starting in March. You will be employed by TNG during the duration of the assignment

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.

Your Responsibilities

• Collaborate with the internal teams in locating documentation and reviewing consent for requests related to HBS in AZ.
• Assist in knowledge curation to allow decision making on inventory which maybe in AZ, or third parties. Duties may include handling of HBS during the reconciliation and curation process.
• Work with the HBS C&G team and Biobank leads to ensure that learning from HBS related issues are identified and analysed to enable continuous process improvement.
• Electronically manage HBS retrievals including receipt, tracking, review and approval of requests from internal requestors. Confirm requests against the informed consent, raise requests as the need arises.
• Assist with the resolution of issue and queries relating to HBS within the inventory. Maintain records for HBS stored until it meets final disposal and follow destruction process when initiated.

The Bigger Picture

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 AstraZeneca Biobank 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.

Our Expectations

• Project management experience and skills is preferable
• Experience with administrative tools
• Experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
• Excellent analytical, written and oral communications skills together with excellent English written and verbal communication skills
• Knowledge and understanding of compliance function, health care regulations, laws, and standards (HBS)
• Excellent analytical, written and oral communications skills.
• Proven team working skills
• Ability to work independently
• High ethical standards, trustworthy, operating with absolute discretion