Leads their nominated area within PV Processes, Partnerships and Contracts Team within PS Center of excellence within Chief Medical Office. PV nominated Areas Include: Case Handling, Periodic Reports, Signal Mangement, and Medical Device. Responsiilities include: Design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology, partnerships and services within the area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies. This is a consulting assignment at AstraZeneca in Gothenburg.
- Accountable for the oversight, lifecycle management and strategic planning and development of nominated area and the Safety/Regulatory owned processes, procedural documents and partnerships of their nominated area and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
- Owns and is accountable for the long term stewardship of their nominated area and for successful delivery of the business benefits.
- Accountable to demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement.
- Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement of processes, technology and services within the Safety/Regulatory area they lead.
- 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.
- Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant stakeholders to improve processes.
- Accountable for managing the relationships 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.
- Act as the primary point of escalation for personnel for any risks and issues identified within the assigned area.
- Work with the Section Director, Compliance and Inspection Readiness to monitor the overall performance of the processes and technology within the nominated area. Track and monitor agreed key performance indicators, oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & Risk Management process
- Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers
- Establish a global mind-set 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
- Project manage 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, foster and facilitate a top tier partnership relationship with the outsource provider. Includes championing relationship with internal AZ stakeholders and forging strong partnership with all customers/stakeholders. Ensures that all internal and external relationships and interfaces are managed effectively.
- University degree or equivalent qualification in relevant scientific discipline
- Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals especially related to periodic reporting
- Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role.
- Experience from authoring standards documents (Standard Operating procedures)
- Experience from development and provision of training through virtual meetings and other media
- Experience of leadership of team, either as line manager or project leader
- Experience in outsourcing and partnership with external vendors
- Ability to manage multiple stakeholders
- 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
- PhD in scientific discipline
- Knowledge of new and developing regulatory and pharmacovigilance expectations
- Technology Implementation experience
- Key capabilities:
- Understanding of governance processes
- Process improvement (eg Lean methodology)
- Financial awareness
- Ability to influence without authority
- Open to multiple perspectives
- Balanced perspective
- Solution focused
- Experience with inspection activities
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
2021-06-18, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.
about Randstad Life Sciences.
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.
Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!