Senior Manager, R&D – Regulatory Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the successful execution of IT projects from initial concept through to implementation, ensuring that delivery aligns with scope, timelines, and budget constraints.

• Provide timely updates on project status, address issues and risks proactively, and escalate matters to leadership as necessary.

• Ensure that project/vendor contracts are accurately drafted and receive timely approval.

• Guarantee the successful fulfillment of project Statements of Work, maintaining adherence to project scope, budget, and schedules.

• Serve as the IT platform owner for Regulatory intelligence and publishing systems, along with other assigned systems.

• Act as the application technical lead, facilitating the effective implementation, lifecycle management, enhancements, requirement analysis, design, configuration, data migration, system integration, testing, and validation activities.

• Promote compliance with IT Quality processes and Viatris SDLC methodologies.

• Develop and review lifecycle documentation for the systems under your purview.

• Manage vendor relationships for assigned systems, ensuring prompt communication of any system issues to leadership.

• Maintain a strong understanding of the technical capabilities that support R&D and regulatory business processes.

⛳️ Requirements

• A Bachelor's degree in science, IT, or a related field is mandatory.

• At least 5 years of prior experience as an IT platform owner with a focus on people leadership is required.

• A minimum of 8 years of project management experience within the life sciences sector is essential.

• Familiarity with project management methodologies, including Agile, Waterfall, and Hybrid approaches, is necessary.

• In-depth knowledge of GCP, EMA, FDA regulations, and other relevant compliance standards is required.

• Practical experience in validated GxP environments, including documentation and change management, is essential.

• Extensive technical expertise, particularly in designing and implementing system integrations, is required.

• Hands-on experience in implementing and supporting global R&D and Regulatory applications and processes for electronic lab notebooks is essential.

• Strong business analysis capabilities, including the ability to create detailed process maps for current and future workflows, are necessary.

• Exceptional verbal and written communication skills are a must.

🏝️ Benefits

• Health insurance

• Competitive salaries

• Paid time off

• Flexible work arrangements

• Professional development