At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Within Bayer, we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here
Regulatory Systems and Process Optimisation Lead
Are you passionate about using your regulatory knowledge and process improvement skills to drive streamlined delivery on a global scale? Do you thrive in a dynamic, entrepreneurial environment? If so, we have the perfect opportunity for you! As a Regulatory Systems and Process Optimisation Lead, you will engage with customers across the organization, including Regulatory Information Management system (RIM) end users, key users, SMEs and service providers, to revolutionize the way we work. You will proactively identify and deliver improved and efficient ways of working, seamless change management of the Veeva Vault RIM and supporting systems, enhancing data integrity and user experience. Your efforts will enable real-time decision-making, ensure critical business and health authority deadlines are met successfully and help bring our products to market sooner.
TASKS AND RESPONSIBILITIES
The overall performance and continuous improvement of designated business processes, optimizing processes and driving automation, reflected compliantly in Regulatory systems to deliver value to stakeholders and consumers alike.
Developing and maintaining compliant process documentation, including process maps, guidance documents and standard operating procedures.
Being a key contributor to ensure the GxP validated state of the Veeva Vault RIM system for your designated business processes including:
o Change management and user acceptance testing of RIM system
o the contribution to, and oversight of, CAPAs and deviations
o representation for Global Regulatory Operations at audits and inspections
Designing, implementing and monitoring performance metrics and identify areas for improvement.
Collaborating with cross-functional teams to implement process changes and enhancements.
Designing and facilitating training sessions on process changes and best practices.
Serving as the primary point of contact for process-related inquiries and issues.
Oversight and Governance of service providers.
WHO YOU ARE
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