Global Regulatory Affairs Operations - Content Management Specialist

Menarini Group; Firenze; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Global Regulatory Affairs Operations Specialist to enhance regulatory processes. The role involves supporting Veeva RIM implementation and collaborating with cross-functional teams to optimize workflows. Candidates should possess a Master's degree and experience in Global Regulatory Affairs, along with excellent organizational and analytical skills.

Competenze

• Master's degree in a relevant field required.
• Experience in Global Regulatory Affairs or Operations preferred.
• Familiarity with Veeva RIM implementation is a plus.

Mansioni

• Support implementation and management of Veeva RIM.
• Collaborate with teams to optimize workflows and track submissions.
• Maintain system, support end-users, and enhance planning tools.

Conoscenze

Analytical skills

Problem-solving

Communication

Organizational skills

Formazione

Master's degree in a relevant scientific or IT discipline

Descrizione del lavoro

We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Operations Specialist to join our Content Management team. In this role, the successful candidate will support the Content Management Manager and ensure the effective implementation and management of the Veeva RIM solution.

The role involves supporting existing submission tracking and planning tools, collaborating with cross-functional teams including Regulatory Affairs, CMC, IT, PV, and Quality to manage regulatory processes within the Veeva platform.

Main Activities & Responsibilities:

• Support the implementation of Veeva RIM (Submission and Submission Archive Modules), including design, configuration, validation, testing, migration, training, and deployment.
• Work with stakeholders to map current processes and identify opportunities to optimize workflows within Veeva RIM, ensuring consistency and harmonization.
• Support and enhance the current regulatory project planning, tracking, and reporting tools, including developing dashboards and reports, and integrating with Veeva modules.
• Develop and maintain SOPs and work instructions for Veeva Submission and Submission Archive.
• Post-implementation, maintain the system, support end-users, troubleshoot issues, and gather feedback for improvements.
• Coordinate with IT and vendors on technical issues and system enhancements.
• Maintain the current Document Management System until Veeva is fully operational.
• Assist the Content Management Manager with developing scorecards, monitoring team activities via dashboards, and providing insights for continuous improvement.

Job Requirements:

• Master's degree in a relevant scientific or IT discipline.
• Experience in Global Regulatory Affairs and/or Operations, preferably in the pharmaceutical industry.
• Experience with Veeva RIM implementation and management is preferred.
• Strong knowledge of global regulatory requirements (e.g., FDA, EMA).
• Excellent planning, organizational, analytical, problem-solving, and communication skills.
• Effective team player capable of working across organizational levels.
• Fluent in English, both written and oral.