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!The Associate Director, Patient Safety Device & Digital leads the Patient Safety Device, Digital and Diagnostic process area. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.AccountabilitiesResponsible for the lifecycle management assigned Patient Safety processes related to devices, digital and diagnostic.Demonstrate and contribute to a culture of "ownership" and efficient and effective holistic issue management that results in delivery of business needs and includes top-tier customer/partner engagement.Support the oversight of medical device, digital health and in-vitro diagnostic regulations and local requirements that impact Patient Safety and/or require implementation.Serve as the delegate, where appropriate, for the Director, Device & Digital Safety.Support the allocation of and contribution to digital, device and diagnostic consultation requests of Patient Safety.Partner with License Agreement & Contracts where medical devices, digital health or diagnostics are involved.Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.Ensure that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant partners to improve processes.Accountable for being a great partner with supplier(s) providing all external services to the group as appropriate.Partner with system counterparts to ensure an integrated and holistic approach to processes and systems.Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers.Establish a global mindset to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance.Participate in projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross-functional teams.In partnership with peers (Other Nominated Area Leads) establish, champion and facilitate a top-tier partnership relationship with the outsource provider. Includes championing relationships with internal AZ partners and forging strong partnerships with all customers/partners. Ensures that all internal and external relationships and interfaces are handled effectively.Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements.Essential Skills/ExperienceUniversity degree or equivalent qualification in relevant scientific field, with relevant experienceTwo years, Post GraduateThree years, BachelorsAt least two years' professional experience in patient safety, regulatory affairs or in quality management systems relating to medical devices and device constituentsKnowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goalsExperience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for roleExperience from authoring standards documents (Standard Operating procedures)Experience from development and provision of training through virtual meetings and other mediaExperience in outsourcing and partnership with external vendorsKnowledge in project management skills, specifically leading teamsDemonstrated excellent skills in: written and verbal communicationAble to work with a high degree of autonomyAble to represent AstraZeneca externally where requiredDesirable Skills/ExperienceUniversity degree or equivalent qualification in relevant scientific field, with at least five years relevant experiencePhD in scientific fieldKnowledge of new and developing regulatory and pharmacovigilance expectationsExperience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745)When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.At AstraZeneca, we follow the science with curiosity and courage. Our commitment to Oncology is driven by our ambition to eliminate cancer as a cause of death. With cutting-edge science fused with the latest technology, we aim for breakthroughs that transform medicine. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career dedicated to improving millions of lives.Ready to make a difference? Apply now!
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