Medical Evidence Quality - Dir Training Management & Patient Engagement

A specialist/expert role for Medical Evidence and Patient Engagement in Evidence Quality across the Medical Affairs organization in AstraZeneca. Responsible for developing, implementing, and maintaining PE in Evidence quality processes and metrics and training management strategies for mandatory compliance training in alignment with AZ Code of Ethics and the Global Policies, as agreed with relevant leadership teams across the Medical Evidence organization. Provides support to the Medical Evidence organization in all Regions/Countries at both global and local level to facilitate compliance with mandatory training requirements and to enable individuals to take responsibility for meeting Quality and Compliance objectives linked to patient engagement in evidence generation.
Typical Accountabilities
Medical Evidence Quality
Driving the management of relevant training matrix in all Regions/Countries at global and local level
Support Learning Management System (LMS) Job/Role owners in the management of related learning plans
Be the key contact between the LMS support team and Medical Evidence in questions related to mandatory training
Act as the Business Learning Lead for Medical Evidence
Driving the establishment and implementing policies, procedures and standards for own work and work of others, ensuring compliance with internal and external standards and regulations
Support to Medical Evidence in Quality and Compliance related systems and tools
Ensures own knowledge and knowledge of team members of best practices and new relevant developments is up to date
Interact, when applicable, with relevant Quality and Compliance functions, for example R&D Quality Assurance and Global Compliance, as well as Quality and Compliance roles in in other functions relevant to Medical Evidence deliveries.
Oversight of continuous improvement activities – including driving relevant individual activities
Contributes to an effective collaboration between the areas of Medical Affairs
Interaction other Medical functions – for example, Medical Excellence, Global Payer Evidence & Pricing
Represents Medical Evidence Quality at external events

Patient Engagement in Medical Evidence
Establish relevant policies, procedures and standards focussed on PE in Evidence, ensuring compliance with internal and external standards and regulations
Support the implementation of strategies for PE in Evidence through a network of PE process owners and subject matter experts in markets to proactively mitigate quality risks
Drive the creation and management of relevant training matrix in Global and selected Region/Country
Oversight of PE quality related metrics in selected Region/Countries, including providing guidance on developing and managing these
Tracking of Quality Issues reported with oversight of continuous improvement activities
Establish/support Patient Engagement in Quality and Compliance related systems and tools
Ensure own knowledge and knowledge of team members of best practices and new relevant developments is up to date including regulatory landscaping and competitive intelligence
Interact, when applicable, and contribute to an effective collaboration with functions, for example Global Compliance, Data privacy, Global Nom sigs, GCP, Medical Excellence, Medial TAs (global, regional, markets), Patient Affairs OBU, Patient Science (CMO), PCS
With dotted line reporting into Global Patient Engagement team maintain close interaction and collaboration

Education, Qualifications and Experience
Essential
University Degree in Life Sciences or other appropriate discipline
Minimum 5 years’ experience in pharmaceuticals or a related industry
Strong work ethics and high integrity standards
Strong patient-centric mindset to model organizational values and mission by example
Expert knowledge of training management methodologies and requirements related to the pharma industry
Knowledge of patient engagement principles
Knowledge and experience of corporate governance and relevant regulations, laws and standards
Knowledge of the overall pharmaceutical product development process, including stages of development and role of different functional areas.
Knowledge of the management of observational studies and/or clinical trials
Strong ability to work independently
Demonstrated track record in delivering a new capability or driving a change effort
Ability to collaborate with colleagues at all levels in various geographies
Project Management knowledge and experience

Desirable
Understanding of multiple aspects within Medical Affairs
Extensive knowledge of the latest technical and regulatory developments in area of expertise
Expert knowledge of quality management and good working knowledge of GXP functions and regulations.
Knowledge/previous experience in patient engagement activities, resources, and tools, especially in Evidence area
Proven leadership promoting motivation and empowerment of others to accomplish organizational objectives in a matrix environment
Innovative and creative approach to complex problem solving and confidence to make decisions when there is no certain right or wrong answer.
Creates Clarity for Others to Make Decisions: individual creates the climate for others to act decisively by clarifying roles and responsibilities and limits of decision-making.
Anticipates and/or Removes Obstacles for Others: individual anticipates and removes obstacles so that teams/workgroups can deliver results and succeed.
Demonstrates Courage to Support Decisions: individual demonstrates courage in addressing the underlying issues that prevent effective decision-making.
Effectively challenges the business and positions quality & compliance appropriately to influence decisions: Adopts a solution-oriented approach and focuses on business enablement i.e., achievement of business goals whilst mitigating risks
Managing compliance risk: Anticipates future risks and works to innovate by sharing practices with colleagues
Manages change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.