Systems Analyst – R&D, Clinical, Regulatory & Medical Systems

Location:

Greater Boston, MA (3 days a week onsite)

Engagement:
Contract-to-Hire

Target rate: $60/hr W2 (benefits available)

We are seeking an experienced Systems Analyst to support a growing R&D technology organization within the biopharmaceutical industry. This individual will partner closely with business and technology stakeholders across Clinical Development, Regulatory Affairs, Medical Affairs, Drug Safety/Pharmacovigilance, and other R&D functions.

The Systems Analyst will help evaluate, implement, enhance, integrate, and support technology platforms used throughout the drug development lifecycle. The role requires someone who can work directly with scientific and business teams to understand workflows, data requirements, and operational challenges, then translate those needs into practical technology solutions.

This position will also support initiatives involving data capture, data integration, data migration, reporting, system enhancements, vendor-managed platforms, and ongoing application lifecycle management within a regulated environment.

The ideal candidate brings a combination of R&D business systems experience, strong business analysis capabilities, hands-on Veeva knowledge, and experience operating within GxP-regulated pharmaceutical or biotechnology environments.

• Partner with Clinical, Regulatory, Medical, Drug Safety, and other R&D stakeholders to understand business processes, system requirements, workflows, and data needs.
• Gather, analyze, document, and translate business requirements into functional and technical requirements for R&D technology solutions.
• Support the evaluation, implementation, enhancement, and ongoing operation of applications used across the R&D organization.
• Develop and maintain appropriate software development lifecycle and computer system validation documentation
  .
• Collaborate with cross-functional partners including R&D business teams, IT infrastructure, Quality, Validation, cybersecurity, external vendors, and technical support organizations.
• Coordinate application configurations, upgrades, releases, enhancements, incidents, and support activities with internal teams and software vendors.
• Support and lead data migration, data mapping, data curation, and system transition activities when required.
• Assess existing systems and processes, identify gaps, and recommend improvements that align technology capabilities with business requirements.
• Troubleshoot application, integration, and data-related issues and coordinate resolution across internal and external support teams.
• Manage competing priorities across strategic initiatives, application releases, enhancements, production support, and day-to-day operational needs.
• Ensure systems and solutions comply with applicable GxP requirements, FDA expectations, cybersecurity standards, internal policies, SOPs, and validation practices
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• Build strong working relationships between R&D business functions and technology teams.
• Participate in solution design discussions involving system integrations, automation, data flows, and supporting infrastructure.
• Provide oversight and coordination for third-party technology vendors supporting R&D platforms and applications.

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline, or equivalent professional experience.
• Approximately 5-8 years of experience supporting technology solutions within R&D, ideally across Clinical, Regulatory, Medical Affairs, Drug Safety/Pharmacovigilance, Research, or related life sciences functions.
• Experience working within the pharmaceutical, biotechnology, or life sciences…