Every day, we rise to the challenge to make a difference and here's how the Senior Manager, R&D and Regulatory Systems will make an impact:
We are seeking an experienced IT Project Leader with a strong background in R&D and Regulatory Affairs. The ideal candidate will manage end-to-end projects, coordinate cross-functional teams, ensure compliance with regulatory requirements, and deliver projects within scope, budget, and timeline. This position manages system enhancements and is the IT platform owner for assigned R&D and Regulatory systems. This position will manage external and internal resources.
Key responsibilities for this role include:
- 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, 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.
- Establish and maintain strong relationships with customers.
- Collaborate with key business users to identify business needs and translate these needs to user requirements. Translate user requirements into technical requirements and implement solutions to meet these requirements.
- Provide business analysis techniques including business and functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis.
- Provide good working knowledge of data standards and conventions for Regulatory and R&D systems.
- Provide guidance to direct report(s) and perform other duties as assigned.
The minimum qualifications for this role are:
- 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.
- Ability 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.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.
At Viatris, we offer 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.
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