Processes Manager, Regulatory Processes
Qrios Minds AB / Biomedicinjobb / Göteborg
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hela Sverige Do you have expertise in regulatory issues and are looking for new ways to develop? Are you highly collaborative and like to take the lead in driving process improvements? This opportunity as Processes Manager in the Regulatory Process and Compliance team might be the right opportunity for you.
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Global Regulatory Excellence's vision is to Leading enterprise wide regulatory strategies, policy and delivery - so that no patient waits. In the Regulatory Process and Compliance team we network collaboratively to enable our customer groups to operate efficient processes in a compliant manner.
Responsibilities
As a Processes Manager in the Regulatory Process and Compliance team you will be working with the Processes Leads and taking responsibility for the management of assigned AstraZeneca projects-processes including implementation, communication, compliance, performance, and inspection readiness. Act as technical writers and project management support to ongoing procedural document update program, including communication and training activities.
You will be accountable to execute the delivery of the process strategy, priorities, alongside governance, authoring and lifecycle management current procedural documents. We hope that you have the drive to establish a culture of continuous improvement, high performance, flexibility and quality, emphasizing a "can do" attitude and innovative approach.
Other key responsibilities in this position:
• Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
• Using deep understanding of regulatory processes and regulations provide process support to regulatory teams and submissions.
• Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
• Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes
• Identify issues and risks and propose options to mitigate them
• Provide process training to relevant functional groups.
• Serve as the delegate, where appropriate, for the Process Leads
• Contribute to communication and change management activities associated with process initiatives.
• Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships
Your profile
Essential for the role
• A science/pharmacy/nursing degree, with relevant experience (pharmaceutical, regulatory, safety and partnership)
• Experience in working cross-functionally
• Leadership skills, including proven project teams experience
• Thorough scientific knowledge sufficient to understand all aspects of regulatory and partnership issues
• Thorough knowledge of the drug development process
• Good attention to detail
• Excellent written and verbal communication skills in English
• Proven ability to work across cultures
Desirable for the role
• MSC/PhD in scientific discipline
• Knowledge of new and developing regulatory expectations
• Knowledge of existing AstraZeneca external alliances and collaborative projects
• Knowledge of Regulatory operating model and organisation
• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development
About the organisation
This is a consultant assignment at AstraZeneca in Göteborg until 2024-06-30. During this time you will be hired by QRIOS.
About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world's leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Ersättning Fast lön
Så ansöker du Sista dag att ansöka är 2023-09-06
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "888".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Qrios Minds AB (org.nr 556599-5999),
http://www.qrios.se/ Arbetsplats Qrios Life Science & Engineering AB
Kontakt Alma Foric
alma.foric@qrios.se 073-850 49 73 Jobbnummer 8062860
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