Associate Systems Analyst

*What you will do*

Associate Systems Analyst - DocuBridge in this role will play a key role in implementation and lifecycle management of structured regulatory submission solutions, with a main focus on Lorenz DocuBridge. This role demands, hands-on experience with Lorenz DocuBridge, and the ability to assist in collaborating with multi-functional partner relationships across business, IT, and vendor teams.

The candidate will collaborate with internal Regulatory Affairs stakeholders and vendor partners to ensure accurate interpretation of requirements. The role includes assisting in validation testing, user grievance resolution, and overall user experience optimization. Timely submission is critical, and the candidate must support the project to closure within set timelines and quality standards.

• Assist in the implementation, operations and validation testing of Lorenz DocuBridge Suite, ensuring the solution meets both global and regional regulatory requirements (e.g., eCTD & NeeS).
• Collaborate with multi-functional partners including Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and translate them into scalable, compliant technical solutions.
• Support the team in defining and managing project plans, timelines, resource allocation, and key landmarks to ensure end-to-end project execution - from system assessment, procurement, configuration, validation, launch, to post-production support.
• Assist in driving validation and compliance readiness by developing validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11guidelines.
• Ensure regulatory submission readiness by enabling structured document authoring workflows, lifecycle management, and integration with content sources such as Regulatory Veeva RIM.
• Work on user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
• Support the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
• Support team to Develop training materials and conduct hands-on user training to onboard regulatory users and business owners, ensuring effective adoption of the system.
• Monitor production performance and work with business team and vender partner to solve issues, ensuring timely resolution of incidents with minimal impact on business continuity.

Basic Qualifications:

• Bachelors degree and 2 to 6 years of relevant experience

Must-Have Skills:

• Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Experience in applying technology standard process methodologies such as Scaled Agile (SAFe) and ITIL.
• Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Possess strong knowledge of information systems and network technologies.
• Experience on working with Submission tools.
• Experience in Systems Development Life Cycle (SDLC), including requirements gathering, design, data analysis, testing, and change control

Good-to-Have Skills:

• Experienced in relational database (e.g. Oracle, PostgreSQL) and writing SQL
• Knowledge of one or more general programming languages, including but not limited to: Java or Python
• Knowledge of API integrations such as MuleSoft & Databricks
• Experience working in cloud services such as AWS
• Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11 and GxP Compliance
• Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG)

Professional Certifications:

• SAFe for Teams certification (preferred)

Soft Skills:

• Excellent analytical and problem-solving skills with a good attention to detail
• Ability to deal with ambiguity and work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to influence and hold team members accountable to commitments

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.