Senior Systems Analyst (R&D IT – Clinical, Regulatory & Medical Systems)
About The Position
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
- 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.
- 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.
- Ability to evaluate and adopt new technologies to support business needs.
- 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.
Nice To Haves
- Familiarity with AWS cloud technologies is a plus.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
