Global Nominated Signatory Leader

at  AstraZeneca

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing!
As a Global Nominated Signatory Leader you will apply medical governance within the designated therapeutic area and drive excellence through focus on medical quality and standards, guiding marketing and medical activities to be undertaken in a compliant and ethical manner. Provide training for global teams according to business need. Advising on, reviewing and approving materials and events designed and produced by Global Brand teams with respect to Company standards including the Global Policies on Ethical Interactions and providing information on our products as well as the regulatory requirements and applicable external codes including the IFPMA, EFPIA and ABPI codes of practice.

MINIMUM REQUIREMENTS:

• UK registered Pharmacist or registered medical doctor
• Advanced bioscience or pharmacy/medical qualification with experience of the pharmaceutical industry including medical affairs and compliance
• Good scientific understanding of the allocated therapeutic area
• Sound knowledge of ABPI code and international medical compliance legislation, codes of practice and their practical application
• Knowledge and experience of corporate governance are desirable
• Experience of successful cross functional and worldwide influencing
• Skills and Capabilities (Expected Target level 3 or 4)
• High ethical standards. An understanding of ethical decision-making processes and an ability to discuss ethical and regulatory issues with credibility and authority.
• Strong interpersonal and leadership skills with demonstrated ability to lead change across national, cultural and functional divides.
• Strong independence and credibility.
• Excellent communication and presentation skills.
• Innovative and creative approach to complex problem solving and confidence to make decisions when there is no certain right or wrong answer. Uses Deep Insight to Impact Broadly: individual is still thinking broadly, but also identifies opportunities and develops solutions that impact beyond their role/function
• Strong strategic thinking ability.

• Act as the AstraZeneca authority and leader on medical quality and standards for the allocated therapy area. This includes promotional claims acceptability (including avoiding off-label claims); interactions with healthcare professionals; cross border digital activities, medical ethical acceptability and other matters within the scope of the IFPMA, EFPIA and ABPI Codes of Pharmaceutical Marketing Practices.
• Lead the AZ approach and tone for medical standards within the designated therapy area. Ensure that the importance is recognised and integrated into everyday business while avoiding unnecessary inhibitions to creativity and actively supporting innovation through deep understanding of the regulations.
• Support for Global, Regional & Marketing company colleagues through training that drives high standards
• Supervise the application of relevant Global policies and SOPs within the allocated therapy area
• Guide Marketing Company Nominated Signatories and others worldwide on standards for the allocated brands and therapy area activities
• Work with commercial, compliance, audit and legal functions to develop and implement company policy interpretation and guidance on difficult and controversial compliance and ethics topics relevant to the therapeutic area
• Pro-actively and reactively work with the Marketing Company Nominated Signatories providing help and guidance on difficult approval issues relating to their allocated therapeutic areas.
• Support the Global Nominated Signatory Practice Director in knowledge sharing between Global, Regional and Marketing Company medical compliance functions, and other stakeholders, with respect to optimising brand messages and claims within the codes, regulatory and ethical constraints.