Senior Systems Analyst (R&D IT – Clinical, Regulatory & Medical Systems)

Description

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

Position Overview

Location: Waltham, MA (Hybrid)

We are seeking a Senior Systems Analyst to join a growing R&D IT organization supporting Clinical Development, Regulatory Affairs, Medical Affairs, and Drug Safety business functions. This individual will work closely with scientific and business stakeholders to evaluate, implement, enhance, and support critical systems and technology solutions that enable research and development activities.

The ideal candidate will have experience supporting life sciences organizations, partnering with stakeholders to optimize data capture, data integration, reporting, and business processes while ensuring compliance with regulatory requirements and industry best practices.

Requirements

Key Responsibilities

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

• Gather, analyze, and document business and system requirements.

• Create and maintain software lifecycle and system documentation.

• Partner with cross-functional teams including R&D, Infrastructure, Validation, Quality Assurance, and external vendors.

• Support system implementations, upgrades, enhancements, and release activities.

• Manage vendor relationships and coordinate support, configuration, and maintenance activities.

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

• Identify process gaps and recommend technology solutions and improvements.

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

• Balance strategic projects, system releases, and operational support activities.

• Ensure compliance with regulatory requirements, cybersecurity standards, SOPs, and departmental policies.

• Build strong relationships between business stakeholders and IT teams.

• Support FDA computer system validation and compliance activities.

Required Qualifications

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

• 5-8 years of experience supporting Clinical, Regulatory, Medical Affairs, Research, or Drug Safety organizations.

• Experience within the pharmaceutical, biotechnology, or life sciences industry.

• Hands-on experience with Veeva platforms and applications.

• Strong understanding of business analysis and systems implementation methodologies.

• Experience working in GxP-regulated environments.

Technical Skills

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

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

• Experience supporting validated systems and compliance-focused environments.

• Working knowledge of Linux and basic scripting.

• Familiarity with AWS cloud technologies is a plus.

• Ability to evaluate and adopt new technologies to support business needs.

Core Competencies

• Strong communication and stakeholder management skills.

• Ability to translate business requirements into effective technology solutions.

• Experience collaborating with vendors, technical teams, and business partners.

• Strong analytical and problem-solving capabilities.

• Excellent troubleshooting and issue-resolution skills.

• Ability to manage multiple priorities and competing deadlines.

• Collaborative mindset with a focus on building productive working relationships.

• Flexible and adaptable approach to supporting evolving business needs.

Work Environment

This position is based in Waltham, Massachusetts and follows a hybrid work model. The role offers the opportunity to work closely with scientific, clinical, regulatory, and medical teams while supporting technology initiatives that drive research and development success across the organization.

Travel: No routine business travel is expected.