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

Grünenthal Group; Origgio; Ibrido; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company based in Origgio, Lombardy is seeking a Regulatory Affairs Digital Product Champion. The role involves championing the Veeva Vault RIM suite and supporting cross-functional teams in regulatory processes. Qualified candidates will have a university degree in Life Sciences or related field, build strong customer relationships, and possess 5+ years' experience with Veeva Vault RIM. The role is full-time and hybrid.

Competenze

• 5+ years working experience with Veeva Vault RIM Suite.
• Deep expertise in Regulatory Information Management processes.
• Excellent team collaboration skills.

Mansioni

• Provide expertise with using Vault RIM suite to Global Regulatory Affairs.
• Support business users with best practices and usage of system functionality.
• Lead adoption of ERON across functions.

Conoscenze

Expert level understanding of Veeva Vault RIM Suite

Regulatory Information Management processes

Structured data submissions

Regulatory affairs processes

Excellent communication skills in English

Formazione

University degree in Life Sciences, Regulatory Affairs, or related

Strumenti

Veeva Vault RIM Suite

Descrizione del lavoro

Overview

Regulatory Affairs Digital Product Champion (m/f/d) – Grünenthal Group

Join to apply for the Regulatory Affairs Digital Product Champion (m/f/d) role at Grünenthal Group.

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.

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.