IT Systems Analyst

This is a unique opportunity for an experienced IT systems analyst to join our organization and play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions.

The successful candidate will have strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. They will work closely with cross-functional teams to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements.

Key Responsibilities:

• Support the implementation and system management of Lorenz DocuBridge Suite, ensuring alignment with global and regional regulatory requirements.
• Collaborate with cross-functional teams to gather business requirements and translate them into technical solutions.
• Assist in defining and executing project plans, timelines, and resource allocation from system assessment through to deployment and post-production support.
• Contribute to validation planning and execution, including IQ/OQ/PQ protocols, aligned with GxP and 21 CFR Part 11.
• Support structured document authoring workflows and content lifecycle management in integration with systems like Veeva RIM.
• Oversee system configurations such as user access controls, audit trails, and role-based security.
• Manage system change control aligned with ITIL practices to ensure compliance and traceability.
• Develop training content and conduct end-user training for regulatory users and business stakeholders.
• Monitor system performance, address issues in collaboration with vendors and business teams, and ensure minimal disruption.
• Drive continuous improvement to enhance system usability, performance, and compliance.
• Track KPIs and provide leadership with system performance, adoption, and risk updates.
• Contribute to strategic roadmap planning for enhancements, upgrades, and integrations (e.g., eValidator, API tools).
• Represent the team as a subject matter expert during audits, inspections, and regulatory reviews.
• Support agile methodologies to adapt to evolving project needs and priorities.
• Use tools like Jira and ServiceNow for issue tracking, service requests, and project reporting.
• Provide leadership and foster a collaborative and productive environment.

Qualifications:

• Master's degree or Bachelor's degree with 5 to 9 years of relevant experience.

Mandatory Skills:

• Strong understanding of pharma regulatory compliance (FDA, EUCTR).
• Hands-on experience with Lorenz DocuBridge and Veeva RIM.
• Demonstrated experience in managing IT initiatives and collaborating across teams.
• Ability to manage multiple priorities with minimal supervision in a dynamic environment.
• Knowledge of IT methodologies including Scaled Agile (SAFe) and ITIL.
• Excellent communication and collaboration skills.
• Strong understanding of information systems and network technology fundamentals.

Desirable Skills:

• Familiarity with relational databases (MySQL, SQL Server, PostgreSQL).
• Proficiency in programming languages such as Python, JavaScript.
• Experience with ETL tools like Informatica or Databricks.
• Knowledge of API integrations (e.g., MuleSoft).
• SQL query development experience.
• Hands-on with reporting tools such as Tableau, Spotfire, or Power BI.

Certifications:

• Veeva Vault Platform Administrator or equivalent (mandatory).
• SAFe for Teams (preferred).

Soft Skills:

• Strong analytical and troubleshooting skills.
• Excellent verbal and written communication.
• Ability to work in global, virtual, and cross-functional teams.
• Team-oriented mindset and goal focus.
• Confident presentation and public speaking abilities.