Associate Director, Digital

4 weeks ago

Macclesfield, United Kingdom AstraZeneca Full time

**Associate Director, Digital & Devices Safety Scientist** **- 18 months FTC (Ending 27th September 2024)**:
**About AstraZeneca**:
**AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.**:
**Come and join our AZ team where you will play a pivotal role in this exciting period of development**:
**Key Responsibilities**:

- ** Provide and be responsible for the medical and scientific input to the device and/or digital program’s design and development**:

- ** Contribute to developing clinical device and/or digital documents, such as hazard assessments, in collaboration with the Device & Digital Safety Physicians**:

- ** Review, analyse and interpret safety data obtained to support device and digital development in collaboration with the Device & Digital Safety Physicians**:

- ** Responsible for device safety activities associated with combination products, supporting the Patient Safety Therapeutic Product teams with device regulatory requirements**:

- ** Perform duties as Medical Device Surveillance Leader for complex and/or multiple products**:

- ** Take accountability and lead resolution of safety issues and mediate cross-functional agreement related to assigned medical devices or digital assets**:

- ** Participate in cross-functional process improvement or other initiatives related to digital and devices on behalf of the Patient Safety organisation**:

- ** Contribute to the generation of Patient Safety’s position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities**:

- ** Support individual PS TA’s project/product teams with their implementation and use of digital and devices in association with their assigned AZ medicinal project/product**:

- ** Responsible for the Patient Safety Device, Digital and Diagnostic SharePoint site, including contribution and delivery to consultation requests**:

- ** Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements***:
**Requirements**:

- ** Healthcare degree (e.g. RN, MD, MBBS) with at least three years of clinical experience post-registration, maintaining registration OR University degree or equivalent qualification in a relevant scientific field, with at least six years of medical device/device constituent experience and post-graduate training to your support ability to approve clinical documents**:

- ** Knowledge and understanding of global medical device and digital health requirements and an ability to balance this with industry standards to achieve business goals**:

- ** Excellent written and verbal English**:

- ** Experience of leadership of a team as a project leader**:

- ** Ability to manage multiple partners**:

- ** Extensive knowledge in project management skills, specifically leading teams**:

- ** Demonstrated excellent skills in: written and verbal communication**:

- ** Able to work with high degree of autonomy**:

- ** Able to represent AstraZeneca externally where required**:

- ** Key capabilities**:

- ** Understanding of governance processes**:

- ** Process improvement (e.g. Lean methodology)**:

- ** Collaboration/co-ordination**:

- ** Ability to influence without authority**:

- ** Open to multiple perspectives**:

- ** Balanced perspective**:

- ** Solution-focused**:

- ** Experience with inspection activities***:
**Desirables**:

- **University degree or equivalent qualification in relevant scientific field, with at least five years relevant experience**:

- ** PhD in scientific field or Engineering degree**:

- ** Experience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745)**:

- ** Line management experience**:
**AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.**:
**So, what’s next**:
**Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you**:
**Competitive salary and benefits package on offer.**:

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