Would you like to use your experience in Biosamples Regulations to make a positive impact to millions of patients' lives across the world? If you would, this could be the role for you...
At AstraZeneca be empowered to be innovative and creative where difference is valued. Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serveHuman 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 Associate Director, Compliance
is responsible for defining and managing processes to deliver HBS compliance across AstraZeneca R&D
. They identify and support establishment of effective HBS compliance procedures and advise the business on requirements. This includes requirements related to re-use of AZ samples, external sourcing of HBS and related services and collaborations.
The role may support clinical or pre-clinical activities as required by the business and is expected to ensure senior leaders are aware of changing regulations and the impact to AZ of these changes.Typical Accountabilities, what you will be doing:
Education, Qualifications, Skills and Experience: Essential:
- Lead the Identification and establishment of effective HBS compliance procedures across R&D.
- Manage HBS processes to ensure standards are adhered to and compliance requirements are consistently applied
- Ensuring senior stakeholders are aware of changing legislation that impacts them
- Support the business with compliant use of HBS through expert advice and decision making
- Ensure risks arising from HBS due diligence activities are identified and recorded.
- Maintain the documentation/SOPs associated with HBS due diligence activities
- Monitor the effectiveness of HBS due diligence processes and identify opportunities for improvement.
- Support approval of HBS suppliers and orders to deliver timely and effective decisions
- 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
- Support activities to enable access to new HBS sources ensuring AZ compliance with regulation
- Act as subject matter expert, reviewing informed consents and making recommendations on HBS use and carrying out audits to ensure compliant use of clinical HBS
- May act as secretary for the HBS Governance and Compliance related meetings, including the dissemination of policy positions and decisions to key stakeholders
- Degree level education
- Experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
- Expert in global regulations relating to HBS
- Excellent analytical, written and oral communications skills
- High ethical standards, willingness to challenge inappropriate proposals/actions of senior leaders
- Strong collaborative, partnering, and interpersonal skills
- Strong ability to work independently
- Willingness to take decisions.
- Fluent in English
- Direct experience of working with HBS
- Knowledge of HBS regulations, laws and standards
- 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
Cambridge (Melbourn Science Park) UK, Gothenburg Sweden, Warsaw Poland or Gaithersburg USSalary:
Competitive + Excellent BenefitsClosing Date:
30th July 2021
Next steps, if the role looks suitable please apply!Where can I find out more?
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