Senior R&D IT Systems Analyst - Data, Regulatory & Veeva

Alkermes; Boston (MA); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Hybrid work model

Office in Waltham MA

Annual performance bonus

Competitive benefits

Job summary

Alkermes is seeking a Sr. Systems Analyst within the R&D IT team to evaluate, implement, enhance and support systems across Development, Clinical, Regulatory and Medical groups.

This role focuses on optimizing data capture, aggregation and analysis to support discovery, clinical and regulatory activities. They will collaborate with scientists and IT to translate business needs into robust infrastructure and solutions, while ensuring compliance with FDA and GxP guidelines.

Qualifications

• Bachelor’s degree in computer science, Information Systems, Engineering or equivalent.
• 8+ yrs experience supporting discovery, clinical, regulatory, medical organizations
• Experience in the pharmaceutical/biotech industry strongly preferred
• Hands on working knowledge of Veeva systems

Responsibilities

• Understand business processes, requirements and data flows with stakeholders
• Create and update software lifecycle documentation
• Partner with cross-functional teams including R&D, Infrastructure, Validation, QA, Info Security, vendors
• Develop and manage vendor relationships, coordinating configurations, upgrades, releases, requests and support
• Lead data migration projects across the R&D organization
• Analyze gaps and opportunities for process improvements
• Coordinate issue resolution with internal and external technical support
• Prioritize tasks between strategic initiatives, releases and daily activities
• Ensure adherence to regulatory requirements, cybersecurity standards, SOPs
• Build strong relationships between business and IT
• Lead and influence cross-functional collaboration
• Oversee vendor relationships for implemented systems
• Ensure FDA computer systems validation compliance

Skills

Veeva systems experience

GxP compliance

Data analysis

Linux scripting

Effective communication

Education

Bachelor’s degree in CS/IS/Engineering

Tools

Veeva systems

AWS

Job description

Alkermes is seeking a Sr. Systems Analyst within the R&D IT team to evaluate, implement, enhance and support systems across Development, Clinical, Regulatory and Medical groups.

This role focuses on optimizing data capture, aggregation and analysis to support discovery, clinical and regulatory activities. They will collaborate with scientists and IT to translate business needs into robust infrastructure and solutions, while ensuring compliance with FDA and GxP guidelines.