Edwards Lifesciences Analyst, Project Management in Irvine, California
As a critical member of the TMTT Marketing team, the Analyst, Project Management role will align and drive cross functional labeling activities to organizational priorities for all business unit commercial and investigation devices. This person will have the opportunity to work in a dynamic environment with highly motivated R&D, Quality, Regulatory, and other key cross functional team members to drive projects through an essential process and establish labeling deliverables required in order to deliver TMTT devices to patients for commercial product lunches and clinical trials.
Align and drive cross functional labeling activities to organizational priorities
Translates the needs and requirements of the business unit to the Global Labeling team, and disseminate information from Global Labeling back to the business unit
Determines labeling project requirements and responsibilities across cross functional team members
Task key stakeholders to drive deliverables to project timelines
Submits labeling creation requests, develop and maintains timelines, and execute on project requirements
Manage changes to the project scope and adjust project timelines and schedule accordingly
Manages project documentation and updates accordingly to reflect labeling changes.
Establishes and maintains team members, regional, and global project stakeholder relationships, expectations and communications
Provides guidance, strategy recommendations, and issues solutions in various business scenarios
Bachelor's Degree or equivalent professional experience with 2 years of experience in managing complex projects in a team environment
Medical device project management or industry experience preferred
• Extremely organized and detail oriented, but must be able to see the bigger picture
• Strong analytical and problem-solving skills
• Excellent written and verbal communication
• Knowledge of project management standards and processes
• Experience in managing multiple projects and management tasks
• Excellent in Microsoft Word, Excel, Project, PowerPoint, and Adobe
• Experience in working in positions where documentation is critical and essential
• Ability to foster strong relationships, including ability to negotiate, motivate, and drive results across a team
• Understanding of medical and/or pharmaceutical design control processes, regulations, and documentation standards
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.