Sr Associate IS Engineer

Job Description

Role Overview

The Sr. Associate IS Engineer CTRS will support the Regulatory and Clinical Trial Submission (CTRS) product team by designing, developing, and maintaining software solutions to meet critical business needs. The role involves close collaboration with product managers, designers, engineers, and vendor partners, with a focus on applications like Disclose from Citeline and docuBridge Suite from Lorenz. The ideal candidate will bring hands-on technical expertise along with deep knowledge of regulatory submissions and clinical trial disclosure systems, playing a key role in maintaining application performance, compliance, and innovation.

Roles & Responsibilities

- Design, develop, and maintain software applications aligned with clinical trial registration and regulatory submission needs
- Ensure system performance and availability for critical business applications such as Disclose and docuBridge
- Manage project scope, risks, and timelines to ensure successful software delivery
- Translate conceptual ideas into working code for rapid and effective development
- Apply SDLC principles to drive efficient software development processes
- Utilize ITIL and ITSM processes for reliable IT service delivery
- Work with business stakeholders to translate functional needs into data and technical requirements
- Provide technical guidance and mentoring to junior developers
- Collaborate with vendor partners on ETL pipelines (primarily Databricks/AWS) to support the disclosure platform
- Ensure complete and correct data flow from internal systems to Disclose
- Conduct User Acceptance Testing (UAT) and validate performance and data integrity
- Develop solutions using innovative technologies, including generative AI
- Maintain code quality through testing strategies including unit and integration tests
- Create and maintain technical documentation for architecture, deployment, disaster recovery, and operations
- Analyze functional and technical requirements and translate them into software architecture specifications
- Maintain ongoing application support and ensure smooth, continuous operations
- Implement system monitoring tools and dashboards to track health, availability, and performance
- Conduct root cause analysis and implement preventative measures
- Ensure the implementation of system security measures to protect against threats and unauthorized access

Basic Qualifications

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

Must-Have Skills

- Deep understanding of pharma industry regulations and clinical trial disclosure requirements (FDA, EUCTR)
- Knowledge of submission publishing systems such as Lorenz docuBridge, ClinicalTrials.gov, EudraCT, and Veeva Vault
- Experience managing technology initiatives and mentoring development teams
- Ability to work in a fast-paced, dynamic environment with minimal supervision
- Experience applying methodologies like Scaled Agile Framework (SAFe) and ITIL
- Strong collaboration and communication skills
- Solid understanding of information systems, networking technologies, and compliance-driven environments

Good-to-Have Skills

- Knowledge of eCTD specifications and GxP-regulated systems
- Experience in leadership roles within pharmaceutical or technology organizations
- Familiarity with software development lifecycle for GxP systems
- Hands-on experience with SAFe implementation and agile practices
- Strong critical-thinking and decision-making skills
- Knowledge of IS governance practices and cross-functional collaboration
- Broad exposure to IS domains including data, application, and infrastructure layers

Professional Certifications

- ITIL (preferred)
- Scaled Agile Framework (SAFe) for Teams (preferred)
- Veeva Vault platform (preferred)

Soft Skills

- Ability to work independently with minimal supervision
- Skilled in mentoring and team oversight
- Strong gap/fit analysis and analytical skills
- Excellent written and verbal communication
- Effective collaboration with global and virtual teams
- High initiative and self-motivation
- Strong multitasking and prioritization skills
- Team-oriented mindset with a focus on shared goals
- Confident presenter with public speaking skills

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