Compliance Specialist (Permanent Full Time Position)

Melbourn Science Park, Cambridgeshire, UK OR Gothenburg, Sweden OR Gaithersburg, US OR Toronto, Canada.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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

Reporting to more senior compliance professional or manager. Manages technical aspects of projects and associated risks within own specialist area to deliver HBS compliance across AstraZeneca R&D in relation to programmes involving use of HBS in Cell Therapies. Maintains administrative control procedures to ensure standards are adhered to and that elements of compliance program are consistently applied. May give assistance to operational management with regard to general compliance questions and ensure training is available locally where required. May discover/benchmark other organisations in relation to compliance best practice. Increasingly expected to act without supervision or with minimal supervision to manage / deliver high quality project outputs.

Key Responsibilities:

• The Compliance specialist (CS) role is an entry level professional role You will co-ordinate projects and assist in delivery under the supervision effective compliance program with respect to use of HBS in Cell Therapy strategies

• May conduct selected monitoring activities, and provide operational/project support for auditing, investigations, assurance reporting etc related to use of HBS in developing Cell Therapies.

• Supports operational implementation of compliance objectives (aligned with HBS Compliance strategy and objectives)

• Support operational implementation of AZ risk framework and risk register (e.g. including specialist operational and/or project administration for cell therapies

• Provides specialist project management support and/or technical administrative support including but not limited to Global Compliance education and learning programs, management of review and approval processes to support publication and launch of standards and programs, intranet portals

• Manages collation and analysis of business information, consolidation and maintenance of up-to-date documentation and frameworks/standards

• Supports monitoring of progress of initiatives and workstreams through scorecards and metrics

Essential:

• Bachelors Degree level education

• Knowledge and understanding of compliance function, health care regulations, laws and standards related to cell therapies

• 6 months of relevant experience.

• Experience in pharmaceuticals or a related industry

• Excellent analytical, written and oral communications skills

• Demonstrable team working skills

• Ability to work independently

• Project management experience and skills

• Experience with AZ administrative tools

• High ethical standards, trustworthy, operating with absolute discretion
  

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

• Experience in Cell Therapy strategies

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

Next Steps:

• To apply please submit your CV with a covering letter

• Reach out to your recruiter on LinkedIn: https://www.linkedin.com/in/zara-newman/

Date Posted

Closing Date

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.