Senior Manager, R&D and Regulatory Systems

About the role

We are seeking an experienced IT Project Leader with a strong background in R&D and Regulatory Affairs.

Responsibilities

• 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.
• Ensure 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, collaborating with IT teams to maintain deployed systems including managing break fixes, incident management work and system security.
• 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, including the IT change management and quality/testing process for assigned projects/systems.
• 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 and deliver industry leading processes.
• Understand business processes and identify regulatory & R&D trends and policies that could impact current systems.
• Monitor emerging industry and health authority requirements to assess business and system impact and develop the requirements to ensure compliance.
• Create/Review lifecycle documentation for assigned systems.
• Support vendor relationships for assigned systems, ensuring system issues are communicated promptly to leadership.
• Provide guidance to direct report(s) and perform other duties as assigned.

Requirements

• Bachelor's degree in science, IT, or a relatable field required. Advanced degrees are a plus.
• 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 as well as working with migrations and SaaS in a regulated environment.
• Hands on experience implementing and supporting global R&D and Regulatory applications and processes for electronic lab notebooks, lab inventory & informatics solutions, regulatory solutions (eg dossier management, submissions, publishing, labeling intelligence and regulatory insights).
• Strong business analysis skills including building detailed process maps of current and future processes.
• Hands on experience supporting large transformational projects.
• Able to operate in a challenging environment and manage multiple activities, priorities, and deadlines.
• Excellent verbal and written communication skills.
• Works well in and appreciates the value of a global diverse work environment.
• Can see the larger picture as well as identify and efficiently communicate key issues and solutions in complex situation.
• Preferred hands on experience in Agentic AI and python.

Qualifications

• Minimum of 5+ years of experience as IT platform owner and people leadership.
• Minimum of 8+ years of project management experience in the life science domain.
• Advanced degrees are a plus.
• Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards.
• Hands-on experience with validated GxP environments including documentation and change management.
• Broad technical knowledge, including hands on experience designing and implementing system integrations as well as working with migrations and SaaS in a regulated environment.
• Hands on experience implementing and supporting global R&D and Regulatory applications and processes for electronic lab notebooks, lab inventory & informatics solutions, regulatory solutions (eg dossier management, submissions, publishing, labeling intelligence and regulatory insights).
• Strong business analysis skills including building detailed process maps of current and future processes.
• Hands on experience supporting large transformational projects.
• Able to operate in a challenging environment and manage multiple activities, priorities, and deadlines.
• Excellent verbal and written communication skills.
• Works well in and appreciates the value of a global diverse work environment.
• Can see the larger picture as well as identify and efficiently communicate key issues and solutions in complex situation.
• Preferred hands on experience in Agentic AI and python.

Skills

• Strong business analysis skills.
• Hands on experience supporting large transformational projects.
• Able to operate in a challenging environment and manage multiple activities, priorities, and deadlines.
• Excellent verbal and written communication skills.
• Works well in and appreciates the value of a global diverse work environment.
• Can see the larger picture as well as identify and efficiently communicate key issues and solutions in complex situation.
• Preferred hands on experience in Agentic AI and python.

Benefits

Viatris offers competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Pay

The exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.

Schedule

N/A