Head of Global Nominated Signatory
The Head of Global Nominated Signatory is accountable for developing strategies and implementing programs to enhance Nominated Signatory competencies and capabilities worldwide via continuous education programs, global knowledge sharing, and formal accreditation.
The Head of Global Nominated Signatory will serve as the company expert and ultimate internal authority on issues relating to medicines promotion, supporting the business to innovate and succeed within the framework of promotional regulations. The role holder will collaborate with peers and external bodies to shape the landscape for promotional regulations in the UK, Europe and beyond.
The candidate will lead the Global Nominated Signatory team to establish global standards, tools, and templates to provide medical governance and drive excellence through a focus on medical quality and standards across AstraZeneca’s portfolio.
The role ensures to ensure Global Marketing and Medical activities are undertaken in a compliant and ethical manner in accordance with company standards, including the Global Policies on Ethical Interactions and external regulations including the ABPI, EFPIA and IFPMA codes.
People Management, Problem Solving, Communication, Knowledge sharing, Training and Guidance
- Operates confidently as part of a global organization to support improvement initiatives and change management in order to prepare the organisation for future challenges
- Ensure effective interactions with & influencing of senior leaders, including SET members, by providing expert consultation/advice on complex business critical issues to address specific concerns and resolve issues related to medicines regulation
- Proactively identify and implement opportunities to achieve efficiencies in promotional review
- Lead best practice sharing for promotional review across C-SET.
- Develop, coach & mentor individuals within the nominated signatory function, globally and locally.
- Act as the AstraZeneca authority on 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 to promotional regulations, ensuring the importance to patients is recognised and integrated into everyday business while avoiding unnecessary inhibitions to creativity and actively supporting company values.
- Identifies opportunities for innovation and improvement of the function, both globally and across the enterprise.
- Provides support for Global, Regional & Marketing Company Medical colleagues through training that drives high standards for product communications.
- Sets company Standards for the application of promotional regulations.
- Guides Marketing Company Nominated Signatories and others, worldwide, on compliant brand and therapy area activities
- Work with commercial, compliance, audit and legal functions to develop and implement company policy, interpret policy and give guidance on difficult and controversial compliance and ethics topics
- Pro-actively and reactively work with the Marketing Company Nominated Signatories to give guidance on difficult approval issues.
- Work with peer companies and regulatory bodies to shape promotional regulations and Codes of Practice.
People Management, Problem Solving, Communication, Knowledge sharing and guidance
- Heads the global Nominated Signatory function
- Act as the AstraZeneca authority and leader on Nominated Signatory matters and medicines promotion, advising the business at a global and local level
- Guides Global Nominated Signatory Leaders in their responsibilities. 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.
- Act as the authority on medicines promotion principles and AstraZeneca standards to guide local nominated signatories, regional medical teams and global business units on good practices for medicines promotion.
- Ensure that the importance of the regulations and legislation is recognised and integrated into business as usual while avoiding unnecessary inhibitions to creativity and actively supporting ethical conduct that supports the best interests of patients.
- SET policy and standards for company application of promotional regulations for the enterprise and for the global functions.
- Manage the Global Nominated Signatory team. Act as mentor to Global Nominated Signatory Leaders in making challenging decisions about the brands they work on. Manage materials review via external providers, ensuring quality and standards are seamless with internal AstraZeneca standards and that a high quality service is delivered to internal customers.
- Work with commercial, compliance, audit and legal functions to develop and implement company policy, interpret and guide on difficult and controversial compliance and ethics topics relevant to medicines promotion.
- Work with local Nominated Signatories, compliance, quality and legal colleagues to identify medical compliance risks and lead the work to identify and implement solutions.
- Develop and drive the implementation and continuous improvement of Nominated Signatory competence across MCs and regions
- Develop and maintain accreditation criteria, training and continuous education for Nominated Signatories.
- Establish and maintain knowledge and skills sharing systems and processes between Global, Regional and Marketing Company Nominated Signatory functions. Provide
- Pro-actively and reactively work with the worldwide Nominated Signatories providing accreditation standards, capability support and guidance on difficult approval issues.
Global Oversee the design and roll out for the Regional Nominated Signatory improvement programmes, anticipating and managing promotional compliance risks and supporting efficiency, effectiveness, sustainability and continuous improvement.
Minimum Requirements – Education and Experience
- Advanced bioscience or pharmacy/medical qualification
- Significant pharmaceutical or related medical experience (8-10 years)
- Five or more years leadership experience and line management in Medical Affairs
- Significant cross-therapeutic area experience.
- Expert knowledge of international medical compliance legislation, codes of practice and their practical application, in particular, expert knowledge of the ABPI Code of Practice and EFPIA Code
- Significant prior experience as a Nominated Signatory.
- Proven expertise in running capability development programmes. .
- Knowledge and understanding of the pharmaceutical industry ‘political’ environment and of AstraZeneca as an important and leading player.
- Experience of successful cross-functional and worldwide influencing
- Demonstrated project management experience
- Global Experience
- Knowledge and experience of corporate governance
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 authorisation and employment eligibility verification requirements.