Senior Manager, R&D – Regulatory Systems

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Viatris

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

📋 Description

• Manage the successful completion of IT projects from conception to implementation ensuring successful project delivery in scope, on schedule and within budget • Communicate project status and manage issues/risks in a timely manner and promptly escalate issues to leadership • Responsible for ensuring project/vendor contracts are accurate and approved in a timely manner • Ensure successful completion of project Statements of Work including keeping the project scope, budget and timelines on track • IT platform owner for Regulatory intelligence and publishing systems and other assigned systems • Application technical lead supporting the successful implementation, system lifecycle, evolving enhancements, requirement analysis, design, configuration, data migration, system integration, testing and validation activities • Drive compliance with the IT Quality processes and Viatris SDLC processes • Create/Review lifecycle documentation for assigned systems • Support vendor relationships for assigned systems, ensuring system issues are communicated promptly to leadership • Provide strong working knowledge of technical capabilities used to support R&D and regulatory business processes

🎯 Requirements

• Bachelor's degree in science, IT, or a relatable field required • 5+ years of previous experience as IT platform owner and people leadership required • 8+ years of project management experience in the life science domain • Experience with project management methodologies such as Agile, Waterfall, and Hybrid approaches • Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards • Hands-on experience with validated GxP environments including documentation and change management required • Broad technical knowledge, including hands on experience designing and implementing system integrations • Hands on experience implementing and supporting global R&D and Regulatory applications and processes for electronic lab notebooks • Strong business analysis skills including building detailed process maps of current and future processes • Excellent verbal and written communication skills

🏖️ Benefits

• Health insurance • Competitive salaries • Paid time off • Flexible work arrangements • Professional development