Associate Director at AstraZeneca in Gothenburg

We are now seeking an Associate Director, Compliance Human Biological Samples at AstraZeneca, Gothenburg!

Are you someone with experience in the pharmaceutical industry, healthcare-related sectors, or academia/hospital environments specifically related to Human Biological Samples (HBS)? If you have a background involving the review of Informed Consent Forms (ICFs) related to the utilization of HBS, and possess knowledge of the regulatory landscape, laws, and standards governing HBS, then you might be the ideal candidate for the position of Associate Director, Compliance Human Biological Samples at AstraZeneca in Gothenburg.

Purpose, Offer and Benefits

This is a consulting assignment for 1 year starting in March 18th. You will be employed by TNG during the assignment period.

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

• Review and advise on use of HBS in accordance with patient consent.
• Lead the identification and establishment of effective HBS compliance procedures to support review of samples as part of US inventories.
• Manage HBS processes to ensure standards are adhered to and compliance requirements are consistently applied for use of HBS in research for samples in the US for the Amnesty project.
• Support the business with compliant use of HBS through expert advice and decision making
• Ensure risks arising from HBS due diligence activities for US Inventory are identified and recorded.
• Maintain the documentation/SOPs associated with HBS due diligence activities for the US Amnesty project.
• Monitor the effectiveness of HBS due diligence processes and identify opportunities for improvement.
• Perform HBS due diligence reviews for AZ clinical sample use and re-use requests for HBS in the biobank to support delivery of timely and effective decisions.
• Act as subject matter expert, reviewing informed consents and making recommendations on HBS use.

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 HBS Compliance Associate Director is responsible for ensuring the compliant use of samples for research.
They are experienced in the review of informed consent and able to ensure samples are used in accordance with patient wishes, protecting our License to Operate.
They will ensure HBS Compliance procedures are followed with regard to HBS specific policies and standards, and can advise stakeholders on use of samples, including decision making on approval of requests for their use in research.

Our Expectations

• Bsc. degree
• Experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
• Experience in the review of ICFs regarding use of HBS and knowledge of HBS regulations, laws and standards
• Experience of working with multiple stakeholders while maintaining ethical standards and willingness to challenge inappropriate proposals/actions of senior leaders
• Experience in collection and use of HBS as part of ongoing clinical trials is desirable
• Previous experience as a process owner and process improvement is desirable
• Excellent analytical, written and oral communications skills
• Strong collaborative, partnering, and interpersonal skills
• Strong ability to work independently
• Willingness to take decisions
• Excellent knowledge of English, both written and spoken