Sr Associate IS Analyst - docuBridge

Role Overview

The Sr. Associate IS Analyst DocuBridge will play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions, primarily focused on Lorenz DocuBridge. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The candidate will work closely with Regulatory Affairs, IT, Quality Assurance, and vendor partners to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements.

Roles & Responsibilities

• Support the implementation and system management of the Lorenz DocuBridge Suite, ensuring alignment with global and regional regulatory requirements (e.g., eCTD, NeeS)
• 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 Regulatory 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., Lorenz 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

Basic Qualifications

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

Must-Have Skills

• Strong understanding of pharma regulatory compliance (FDA, EUCTR)
• Hands-on experience with Lorenz DocuBridge and Regulatory 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

Good-to-Have 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

Professional 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