Jobs in Vicenza, United States

We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Operations Specialist to join our Content Management team. In this role, the hired person will be instrumental in supporting the Content Management Manager and ensuring the successful implementation and management of Veeva RIM solution.

The hired person will provide support for the existing submission tracking and planning tool and will collaborate with cross-functional teams, including Regulatory Affairs, CMC, IT, PV, Quality, etc. to ensure the efficient and compliant management of our regulatory processes within the Veeva platform.

Main Activities & Responsibilities

• Support the Content Management Manager during the implementation of Veeva RIM (Submission and Submission Archive Modules), including solution design and configuration, validation, testing, migration, training and deployment;
• Collaborate with business stakeholders to map the as-is process and identify opportunities to optimize regulatory processes and workflows within Veeva RIM, ensuring consistency and harmonization of processes;
• Provide support for the currently used regulatory project planning, tracking, and reporting tool. Proactively seek opportunities to enhance it and integrate it with Veeva Submission Module implementation, including development of dashboards and reports for effective activity tracking;
• Collaborate in developing and maintaining standard operating procedures (SOPs) and work instructions (WIs) for Veeva Submission and Submission Archive;
• After Veeva implementation, be responsible for the maintenance of the system up-and-running (end-users support, troubleshooting, training, collection and evaluation of end-users feedback aimed at system improvement);
• Collaborate with IT and vendors to address technical issues and implement system enhancements;
• Be responsible for the maintenance of the current Document Management System in cooperation with Content Management team Members till Veeva is in place;
• Provide support to the Content Management Manager, including but not limited to, i) the development of scorecard and dashboard; ii) the monitoring of team activities with metrics and dashboard and iii) the sharing of actionable insights to drive continuous improvement of the team.

Job Requirements

• Master of Science degree in a scientific discipline, information technology, or a related field;
• 5+ years of experience in Global Regulatory Affairs and or Operations or related discipline preferably in the pharmaceutical industry;
• Proven experience with Veeva RIM implementation and management desired;
• Strong understanding of global regulatory requirements and guidelines (e.g., FDA, EMA);
• Exceptional planning and organizational skills;
• Excellent analytical, problem-solving, and communication skills;
• Excellent team player with the ability to work effectively across all organizational levels;
• Fluent in English, both written and oral.

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