
Global IT R&D Systems Lead
Posted 1 day ago

Posted 1 day ago
This is a fully remote position, open to applicants in United States.
• Oversee IT projects from initiation to execution, ensuring delivery aligns with scope, timeline, and budget.
• Update stakeholders on project status, address issues and risks, and escalate concerns to leadership as necessary.
• Manage contracts with vendors and oversee Statements of Work.
• Take ownership of designated Regulatory intelligence, publishing, R&D, and various IT systems.
• Coordinate system maintenance, issue resolution, incident management, and security measures.
• Lead the implementation of applications, manage their lifecycle, drive enhancements, conduct requirements analysis, design, configuration, migration, integration, testing, and validation.
• Ensure compliance with IT Quality standards and Viatris SDLC processes.
• Develop and review documentation related to system lifecycles.
• Maintain vendor relationships and report system issues to leadership.
• Assist R&D and regulatory business processes while evaluating industry and health authority requirements.
• Foster relationships with customers and work collaboratively with business users to clarify and convey requirements.
• Conduct business analysis, including process modeling, user stories, prototyping, data flows, and root cause analysis.
• Provide mentorship to direct reports and undertake other assigned responsibilities.
• A Bachelor's degree in science, IT, or a related discipline is required.
• A minimum of 5 years' experience as an IT platform owner and in leadership roles is required.
• At least 8 years of project management experience within the life sciences sector.
• Proficiency in Agile, Waterfall, and Hybrid project management methodologies.
• Familiarity with GCP, EMA, FDA regulations, and other standards for regulatory compliance.
• Practical experience in validated GxP environments, documentation, and change management is essential.
• Comprehensive technical knowledge, including the design and implementation of system integrations, migrations, and SaaS solutions in regulated settings.
• Hands-on experience in the implementation and support of global R&D and Regulatory applications and processes.
• Exposure to electronic lab notebooks, lab inventory and informatics solutions, dossier management, submissions, publishing, labeling intelligence, and regulatory insights.
• Strong business analysis capabilities, particularly in detailed process mapping.
• Hands-on experience in supporting large transformational initiatives.
• Ability to juggle multiple tasks, priorities, and deadlines effectively.
• Exceptional verbal and written communication skills.
• Experience in a global, diverse work environment.
• Prior experience as an IT platform owner and in leadership roles is required.
• Preferred hands-on experience with Agentic AI and Python.
• Competitive salaries.
• Comprehensive benefits package.
• An inclusive work environment.
• Commitment to being an Equal Opportunity Employer.
Precision For Medicine
Precision Medicine Group
smartkündigen OHG
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