Regulatory Affairs Digital Product Champion (m/f/d)

​Professional  |  Permanent  |  Full-/ Part-time  |  Hybrid​

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:

• Champion and provide functional expertise with usage of Vault RIM suite – ERON (Registrations, Submissions, Submissions Archive & Publishing) to Global Regulatory Affairs and its enterprise stakeholders. This includes but not limited to supporting business users with:
  • Best practices and agreed usage of Vault RIM system functionality
  • Understanding of data model and object relationship within ERON
  • Understanding of implemented data standards and operating model within ERON
  • Understanding of business process, roles and responsibilities (security model) implemented within ERON
• Lead and support successful adoption of ERON across business functions
• Support development and maintenance of change management and training artefacts – user guides, best practices, videos, etc.
• Provide training and change management support for continuous adoption and desired usage of the system functionality
• Track and maintain business requirements (user requirements and user stories) implemented and its traceability to system functionality and business process, in close collaboration with relevant stakeholders and SMEs (Business Process Team, IT Solution Architects, Software Vendors)
• Responsible for gathering, analysis and documentation of new and emerging requirements
  • Analyze new and emerging requirements to identify solution pathways in close collaboration with relevant stakeholders and SMEs (Business & IT Teams)
• Support quarterly release impact assessment, planning and co-ordination of the change implementation (Veeva Vault RIM and other GRA digital solutions
• Responsible for updating user acceptance test scripts and / or performs user acceptance testing for digital product releases
• Investigate reported functional issues to identify solution pathways in close collaboration with relevant stakeholders and SMEs (Business Process Team, IT Solution Architects, Software Vendors)
• Represent Grünenthal in external product communities to bring shared experience and value back to Grünenthal

What you'll bring to the table
To make the most of this role and truly thrive, you should have:

• University degree in Life Sciences, Regulatory Affairs, Systems and Data Management, or Business Administration
• Expert level understanding and 5+ years working experience with Veeva Vault RIM Suite (Registrations, Submissions, Submissions Archive, Publishing)
• Deep expertise and 10+ years of experience with Regulatory Information Management processes
• Strong understanding & working experience of structured data submissions (IDMP, SPOR, xEVMPD)
• Considerable understanding and 6+ years working experience with regulatory affairs processes supporting lifecycle maintenance of marketed products in the EU & US
• Veeva certified professionals preferred
• Ability to manage multiple tasks simultaneously in a results-driven and customer-focused environment
• Excellent communication and presentation skills in English
• Attention to details, can do attitude and a positive and proactive mindset
• Excellent team collaboration skills, with the ability to work independently when required

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"Join us if you are solution oriented, champion at problem solving and want to make a meaningful impact by driving digital change and adoption supporting Global Regulatory Affairs and its enterprise stakeholders." Argha Nag, the Hiring Manager