Medical Evidence Quality Director

Vor 7 Tagen

Baar, Schweiz AstraZeneca Vollzeit

**Title - Medical Evidence Quality Director** (International)**

**Location - Luton UK or Zug Switzerland.**

**Salary - Competitive with attractive package**

We are now recruiting an** Medical Evidence Quality Directo**r within **BioPharmaceuticals Medical (BPM).**

Medical Affairs ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. Medical Affairs provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. Medical Affairs aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

The Medical Evidence organization is accountable for the delivery of global strategic studies required to generate the evidence to build the confidence on AZ therapies and additional observational, interventional, and externally sponsored research required by Global Product Teams and Global Medical Teams.

A specialist/expert role for Quality and Compliance across the Medical Affairs organization in AstraZeneca. You will be responsible for implementing and maintaining Quality and Compliance strategies in alignment with AZ Code of Ethics and the Global Policies, as agreed with relevant leadership teams across the Medical Evidence organization, business/resource planning, and team leadership. Provides support to the Medical Evidence organization in selected Region/Countries, to enable individuals taking responsibility for meeting Quality and Compliance objectives in their own deliverables.

**Other responsibilities**:

- 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 (sounding board) for questions regarding processes and regulations (for example, GCP)
- 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.
- Responsible for the management of the Quality Management System within the Medical Evidence organization in selected Region/Countries.
- Oversight of quality related metrics in selected Region/Countries, including providing guidance on developing and managing these, in collaboration with the Quality Metrics Coordinator
- Support the management of relevant training matrix in selected Region/Country in collaboration with the Director/Ass Dir Training Management for Medical Evidence
- Provide oversight and guidance on process life cycle management for Medical Evidence process owners in selected Region/Countries
- Oversight of Quality Issues reported from Medical Evidence activities in selected Region/Countries in appropriate reporting system (e.g., VQV)
- Provide 1st line support to Medical Evidence staff and, when applicable Medical Affairs staff, in selected Region/Countries entering Risks and/or Issues in appropriate reporting system (e.g., VQV)
- Support the Medical Evidence organization in selected Region/Countries to be appropriately prepared for audits and inspections - Inspection readiness
- 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

**Essential for the role**
- 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
- 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
- Ability to collaborate with colleagues at all levels in various geographies
- Project Management knowledge and experience

**Desirable for the role**
- Understanding of multiple aspects within Medical Affairs
- Extensive knowledge of the latest technical and regulatory developments
- Expert knowledge of quality management and good working knowledge of GXP functions and regulations.
- Creates Clarity for Others to Make Decisions: individual creates the climate for others to a

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