Job Title: Veeva RIM Consultant

Location-Marlborough, MA

Job Description:

At least 8-9 years of professional experience in the IT industry. Regulatory Affairs Experience in Regulatory information management VEEVA RIM Demonstrated practical working experience in both processes (eg.xEVMPD) and utilizations of regulatory systems (RIMS, VEEVA). Manage and optimize our regulatory information management processes using the Veeva Vault RIM platform. The ideal candidate will have a strong background in regulatory affairs, experience with Veeva solutions, and a deep understanding of compliance requirements within the pharmaceutical or biotechnology industry. This role involves managing regulatory submissions, maintaining regulatory documents, and supporting cross-functional teams to ensure compliance with local and global regulations. Good stakeholder management and communication skills, Strong service mentality Quick comprehension, good analytical and problem-solving skills Ability to work in a virtual and matrix environment.

Key Responsibilities:

Regulatory Information Management:

Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.

Ensure that regulatory submissions comply with applicable local and international regulations and guidelines.

Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.

System Configuration and Maintenance:

Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows.

Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.

Data Management:

Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.

Implement data governance practices to maintain compliance and quality of regulatory data.

Cross-Functional Collaboration:

Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions.

Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.

Process Improvement:

Identify opportunities for process enhancements and automation within the regulatory submission process.

Develop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.

Regulatory Compliance:

Stay updated on regulatory changes and ensure that the organization's processes and systems comply with current regulations and industry best practices.

Participate in audits and inspections as necessary, providing documentation and system access as required.

Qualification: 

At least 8-9 years of professional experience IT industry Regulatory Affairs Experience in Regulatory information management VEEVA RIM Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA)

Good understanding of Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM experience

Good understanding of both processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality

Veeva Vault admin certification is required

Experience with Veeva RIM Connectors is preferred

Good Presentation skills for conducting product demonstrations.

Excellent analytical and problem-solving skills, with attention to detail and accuracy.

Good stakeholder management and communication skills Strong service mentality Quick comprehension, good analytical and problem solving skills Ability to work in a virtual and matrix environment.