Global Regulatory Affairs Operations Innovation and Information Management Senior Associate

2 settimane fa

Florence, Toscana, Italia Menarini A tempo pieno
Overview

Join our Global Regulatory Affairs Operations department as a Senior Associate in the Innovation and Information Management (IIM) area. Reporting to the IIM Manager, you will play a critical role in managing our core regulatory data and systems, ensuring global compliance, and driving the implementation of new technology solutions across the Menarini Group.

If you are a proactive and analytical individual with expertise in regulatory information systems (specifically xEVMPD and Veeva), this is an opportunity to contribute directly to the efficiency and compliance of our Global Regulatory processes.

This is a fixed-term contract position to cover a Maternity Leave Substitution.

Main Activities & Responsibilities

As a Senior Associate, you will focus on three main pillars: Regulatory Data Governance & Compliance, System Management & Support, and Innovation & Project Leadership.

1. Regulatory Data Governance & xEVMPD Management
  • Lead data governance activities, continuous updating, and compliance checks for the central regulatory database.
  • Manage all aspects of xEVMPD (extended EudraVigilance Medicinal Product Dictionary) data within the Registration Database.
  • Perform data transmissions to the European Medicines Agency (EMA) and validate data accuracy in EudraVigilance.
  • Monitor and Analyze xEVMPD guidelines and newly issued EMA documents to ensure continuous compliance.
  • Collaborate with internal xEVMPD team members across company departments to ensure robust data governance and verification.
  • Maintain and Distribute current SOPs, Working Instructions, and training materials for all regulatory database users.
2. System Management & Support
  • Oversee the uploading of product/registration details into the Registration Database, ensuring strict adherence to data governance standards.
  • Execute corrections and amendments within the Registration Database software.
  • Serve as a primary support contact for Registration Database users (Verification and Read-Only users).

  • Manage and Validate system issues and fixes:

  • Interact with Vendors and IT specialists regarding system settings, technical issues, and bug resolution.

  • Perform specific checks and validation tests on bug fixes implemented by Vendor/IT.
3. Innovation & Project Leadership
  • Actively Participate in company-wide projects and initiatives focused on Regulatory Affairs.
  • Contribute to the selection and implementation of new software solutions for regulatory purposes across the Menarini Group.
  • Drive the harmonized and validated use of regulatory software to improve best practices and optimize working processes.
  • Support the Manager of Global Regulatory Affairs Operations, IIM Management in the strategic development and expansion of the Global Regulatory Affairs Operations function.
Job Requirements
  • Education: Master's degree or higher in a scientific discipline, Information Technology, or a related field.
  • Experience: Proven knowledge and hands-on experience with regulatory software applications, particularly those by Veeva (for registration lifecycle and xEVMPD data management).
  • Technical Aptitude: Strong affinity for the IT environment, with proficiency in basic and specific software applications.
  • Language: Fluent in English (written and oral) is mandatory.
Key Competencies:
  • Analytical & Problem-Solving: Excellent ability to analyze complex data, troubleshoot issues, and develop practical solutions.
  • Proactive & Dynamic: A self-starter with a "willing-to-do" and proactive attitude.
  • Organizational Excellence: Excellent planning and organizational skills with attention to detail.
  • Collaboration: Excellent team player with the ability to work effectively and communicate clearly across all organizational levels and international teams.

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