Global IVD Regulatory Center of Excellence Portfolio Manager

Role Summary

Global IVD Regulatory Center of Excellence Portfolio Manager. Lead oncology regulatory strategy programs within the IVD Regulatory COE, supporting development and delivery of medicines and diagnostics.

Responsibilities

• Oversee a global portfolio of IVD regulatory projects, ensuring timely initiation and execution of cross-functional study start-up activities.
• Plan and schedule project timelines and milestones using appropriate tools prior to study start-up.
• Forecast and plan resource requirements (people, financial, technology) for projects across the IVD Regulatory COE/Portfolio.
• Lead and support cross-functional issue resolution and mitigation activities, both internally and externally.
• Coordinate and lead discussions between Oncology Regulatory Strategy and CTRSE Regulatory PM to ensure alignment of decisions.
• Manage and participate in pre-studies, projects, and other activities to increase operational efficiencies and support business imperatives.
• Facilitate dissemination of educational and training materials to advance new concepts and methodologies.

Qualifications

• Must-Have: Bachelor‚Äôs degree required with 4 years experience
• Direct experience leading projects in a highly regulated environment.
• Proven ability to manage multiple projects with competing deadlines.
• Knowledge of IVD manufacturing and associated processes.
• Excellent oral and written communication skills.
• Proficiency with Microsoft applications.

Nice-to-Have

• Masters Degree preferred
• Experience managing pharmaceutical, technical, IVD, or medical device projects and/or clinical programs.
• Experience leading regulatory submissions for IVD and/or drug applications.
• Experience with Microsoft Project or equivalent systems.
• Certification in operational excellence methodologies (e.g., Six Sigma, Lean).

Skills

• Project management
• Regulatory strategy for IVDs and medical devices
• Cross-functional collaboration
• Operational planning and resource forecasting
• Communication and training dissemination

Education

• Bachelor‚Äôs degree required (minimum)

Additional Requirements

• Relocation support may be available
• Hybrid work arrangement; on-site approximately 2.5 days per week within commuting distance