Global IVD Regulatory Center of Excellence Portfolio Manager

Role Summary

Global IVD Regulatory Center of Excellence Portfolio Manager

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 (GSPM) 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’s degree required with 4 years experience
• Must-Have: Direct experience leading projects in a highly regulated environment.
• Must-Have: Proven ability to manage multiple projects with competing deadlines.
• Must-Have: Knowledge of IVD manufacturing and associated processes.
• Must-Have: Excellent oral and written communication skills.
• Must-Have: Proficiency with Microsoft applications.
• Nice-to-Have: Masters Degree preferred
• Nice-to-Have: Experience managing pharmaceutical, technical, IVD, or medical device projects and/or clinical programs.
• Nice-to-Have: Experience leading regulatory submissions for IVD and/or drug applications.
• Nice-to-Have: Experience with Microsoft Project or equivalent systems.
• Nice-to-Have: Certification in operational excellence methodologies (e.g., Six Sigma, Lean).