OverviewRegulatory Affairs Digital Product Champion (m/f/d) – Grünenthal GroupJoin to apply for the Regulatory Affairs Digital Product Champion (m/f/d) role at Grünenthal Group.Professional | Permanent | Full-/ Part-time | HybridIf 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.
Responsibilities

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
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
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
Represent Grünenthal in external product communities to bring shared experience and value back to Grünenthal

Qualifications

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)
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 detail, can-do attitude and a positive and proactive mindset
Excellent team collaboration skills, with the ability to work independently when required

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Science, and Health Care Provider

Industries

Pharmaceutical Manufacturing
Hospitals and Health Care
Biotechnology Research

Referrals increase your chances of interviewing at Grünenthal Group by 2x.
Get notified about new Regulatory Affairs Specialist jobs in Origgio, Lombardy, Italy.
Note: This summary reflects the content of the original description and does not modify factual details.
#J-18808-Ljbffr