Business Consultant

Role:

Required Technical Skill Set:

Experience:

Work Location:

Desired Competencies (Technical/Behavioral Competency)

Must-Have:

1. Experience with R&D specific IT application systems for Document management, trial management, Data management and/or Pharmacovigilance.
2. Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations.
3. Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar).
4. Highly proficient in Information Technology systems, including Microsoft Office suite.
5. Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between.
6. Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference.
7. Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects.
8. Strong analytic skills for large quantities of compliance, risk management and clinical data.
9. Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development.

Good-to-Have:

• Veeva Vault admin certification is required
• Experience with Veeva RIM Connectors is preferred

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.

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.

Responsibility of / Expectations from the Role:

1. Should be able to manage Regulatory information management VEEVA RIM & eTMF Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA)
2. Handle Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM
3. Align with Support Team on current issues and initiate problem management.
4. Prepare and update application related documentation (Operational Instructions, User Manuals).
5. 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.