Senior Systems Analyst II, R&D Systems

Description

Please note: This opportunity is not open to third-party agencies or recruiting firms. Direct applicants only.

Overview

Location: Waltham, MA (Hybrid: 3 days onsite, 2 days remote)

We are seeking a Senior Systems Analyst II to join a growing R&D IT organization supporting Clinical Development, Regulatory Affairs, Medical Affairs, Drug Safety/Pharmacovigilance, and other research-focused business functions. This role will partner with scientific and business stakeholders to evaluate, implement, enhance, and support systems that enable drug development and clinical research activities.

The ideal candidate combines strong business analysis skills with technical expertise, helping to optimize data capture, integration, analysis, and reporting across the R&D landscape while ensuring compliance with regulatory requirements and industry best practices.

Requirements

 Key Responsibilities

• Partner with business stakeholders to understand processes, requirements, and data flows.

• Gather and document business and system requirements using appropriate elicitation techniques.

• Create and maintain software lifecycle and validation documentation.

• Collaborate with cross-functional teams including R&D, Infrastructure, QA, Validation, and Information Security. 

• Lead and support system implementations, upgrades, releases, and enhancements.

• Manage vendor relationships and coordinate support activities.

• Lead data migration and data management initiatives across R&D organizations.

• Analyze business gaps and recommend technology solutions and process improvements.

• Coordinate issue resolution with internal teams and third-party providers.

• Balance strategic projects, system releases, and day-to-day operational support.

• Ensure compliance with GxP, FDA, cybersecurity, and corporate policies and procedures.

• Build strong partnerships between business and IT teams.

• Drive collaboration and influence stakeholders across multiple functional areas.

Required Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, or a related discipline.

• 8+ years of experience supporting Clinical, Regulatory, Medical, Drug Safety, or Research organizations.

• Experience within the pharmaceutical or biotechnology industry.

• Hands-on experience with Veeva applications and platforms.

• Strong understanding of business analysis methodologies and system implementation practices.

• Experience working within GxP-regulated environments.

Technical Skills

• Knowledge of system integrations, automation technologies, and data flows.

• Familiarity with AI tools and large language model (LLM) technologies.

• Understanding of data analytics, reporting, and visualization platforms.

• Experience supporting validated systems in regulated environments.

• Working knowledge of Linux systems and scripting.

• AWS experience is a plus.

 Desired Competencies

• Strong communication and stakeholder management skills.

• Ability to translate business needs into technology solutions.

• Experience working effectively with vendors and third-party partners.

• Excellent problem-solving and troubleshooting abilities.

• Ability to prioritize multiple initiatives in a fast-paced environment.

• Collaborative mindset with strong relationship-building skills.

• Flexible, adaptable, and solution-oriented approach to complex challenges.

Work Environment

This is a hybrid position based in Waltham, Massachusetts, requiring onsite collaboration several days per week while providing flexibility to work the remainder of the time remotely. The role offers the opportunity to work closely with scientific, clinical, regulatory, medical, and technology teams to support innovative research and development initiatives.