Global Nominated Signatory Leader

Location: Cambridge (UK)/Gaithersburg (USA)/Gothenburg (Sweden)

At AstraZeneca we win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do.

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 global marketing and medical activities to be undertaken in a compliant and ethical manner. Provide training for global teams (Marketing, Medical, Corporate Affairs and others) and Nominated Signatories according to business need. Advising on, reviewing and approving materials and events designed and produced by global brand teams with respect to company standards and applicable external codes including the IFPMA code

Accountabilities/Responsibilities:

• 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 Code 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 including Local Nominated Signatories worldwide through training that drives high medical standards

• 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.

• Work with and manage relationships with the outsourced vendor so that internal colleagues see you as one seamless team

Biopharmaceutical Business Unit (BBU) & Oncology Business Unit (OBU) Global-Led Activities, Compliance and Standards

• Provide consultation and feedback on global-led activities, and provide review and approval of materials (including brand strategy documents and promotional claims documents) produced by Global Brand teams within the allocated therapeutic area for compliance with AstraZeneca global policies and standards, applicable codes, regulatory requirements and ethical acceptability

• Act as a final signatory for items and activities that do not undergo local approval including above country digital activities and global press releases.

• Work with Marketing Company Nominated Signatories who undertake final approval according to the local regulatory jurisdiction.

Global Therapeutic Area Medical Standards Leadership

• Sets standards for promotional claims and non-promotional product information sharing; ensuring AstraZeneca’s promotion and communications adhere to regulations and support appropriate use of our medicines in patients as well as driving business goals.

• Advise Global Brand teams on development activities including brand strategy, target product profiles and target product claims with respect to medical standards including draft positioning and claims approvability. Aim to optimise innovation while interpreting the ethical and regulatory requirements.

• Provide training according to business need for Global, Regional & Marketing Company teams to drive quality & high standards

• Drive continuous quality improvement of Global Brand team outputs by providing consultation and feedback to Brand Teams during concept creation and throughout design and development process whilst ensuring consistency of approval decision-making. Provide support in preparing cases for challenge/defence of activities/materials and in intercompany dialogue.

• Identify future compliance and quality risks from commercial and promotional innovation within the therapeutic area and collaborate with the Medical Quality & Standards Head in creating effective and practical medical quality policies and standards to ensure continued commercial success in a compliant and ethical manner.

• Providing support for marketing company Nominated Signatories by answering medicines promotions queries and sharing code cases

• Support marketing companies in the response to and pursuance of marketing code of practice complaints relevant to the therapeutic area, working with marketing company Nominated Signatories, regional compliance staff and other stakeholders including Commercial, Legal and Global Compliance.

Minimum Requirements – Education and Experience, Functional & Business knowledge, Specialist Skills

• Medical qualification or a UK-registered pharmacist with solid experience of the pharmaceutical industry including medical affairs and compliance

• Good scientific understanding of the allocated therapeutic area

• Sound knowledge of international medical compliance legislation, codes of practice and their practical application

• Knowledge and experience of corporate governance are desirable

• Knowledge and understanding of the pharmaceutical industry ‘political’ environment and of AstraZeneca as an important and leading player

• Experience of successful cross functional working

• Experience of working successfully in a global/regional role managing multiple stakeholders and influencing at all levels worldwide is desirable

Skills and Capabilities

• 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 influence and lead change across the organisation.

• Strong independence and credibility. Proactive and able to work on their own initiative and in a result orientated team environment.

• 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.

• Strong strategic thinking ability.

• Strong analytical skills and ability to ascertain the relevant issues from large masses of information.

• Consider and manages needs of multiple stakeholders in AZ decision making and planning.

• Uses deep insight to impact broadly, identifying opportunities and seeking to develop solutions that impact beyond their role/function.

• Direct Reports: None

• Indirect Reports: Required to influence widely including brand team members, senior colleagues and Local Nominated Signatories

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.