Edwards Lifesciences Associate Manager, Program Management in Irvine, California
As a new product development Associate Manager, Program Management , you will lead and manage Critical Care New Product Development (NPD) projects in support of the Critical Care Business Unit strategy within Edwards Lifesciences. From project initiation through closure, you will follow standard program and project management / product development practices and guidelines. You possess a process-orientation and actively suggest and drive changes to the NPD processes and practices as a matter of on-going improvement.
As an NPD Project Manager, the focus will be on managing numerous integrated project initiatives for our regulatory and clinical partners. This candidate will be able to anticipate workload, identify needed resources, map out and manage the various regulatory submission milestones, tasks and deliverables for all NPD project while working closely with the project manager responsible for those projects.
In addition this individual will be coordinating and managing regional market segments while working with our internal and external regulatory, marketing and global supply chain team counterparts. The candidate will have an understanding of regulations and requirements as well as supply chain and product launch logistics.
To be successful in this role, this candidate will have the ability to seamlessly flex between managing multiple projects, owning schedules, outlining key milestones, and trafficking deliverables. The candidate will thrive in a dynamic, fast-paced environment, implement processes and interface with internal and external functions. This role requires excellent project management skills, strategic thinking and problem solving, and strong communication skills. The ideal candidate will be an organized self-starter with a strong bias for action and the ability to work with cross-functional teams and provide guidance for projects.
The NPD Project Manager will:
Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams and reporting into the Program Management Office.
Develop, execute, and maintain clinical study plans and proactively provide status updates to designated stakeholders.
Partners with study site coordinators to prepare IRB submissions, address IRB questions, and achieve site activation.
Ensure that overall regulatory or clinical project timelines are aligned cross-functionally.
Manages post-market clinical studies and other post-market clinical research activities alongside our Clinical partners.
Contribute to process improvement.
Understand the regulatory framework
Ensure deliverables/milestones in project plans are achieved
Define and organize workstream activities for the project and track progress
Ensure resource availability and allocation for workstream activities
Manage workstream priorities and expectations through efficient and effective planning
Proactively anticipate, track and mitigate project-related issues and risks
Organize and communicate baseline schedules and important milestones to end stakeholders, set expectations, responsibilities and follow up as appropriate to projects progress per the baseline schedule
Interface regularly with the project teams to gather project launch milestones and coordinate with the other project managers to ensure the activities align with the global launch strategy.
Ensure that regional approval is achieved and product is cleared through EPAC.
Apply project management expertise, methodologies and department standards.
Leverage well developed interpersonal skills to build and maintain positive working relationships with customers and key stakeholders
Develop tools and metrics to use across projects for future launches
Bachelor's degree preferably in a scientific field; advanced degree desirable.
A minimum of 5 years in the biotechnology industry
Strong project management skills, including proficient use of MS Project and other tools (eg, Smartsheet).
Strong leadership skills and ability to influence stakeholders.
Background in regulatory affairs and project management within the biopharmaceutical or medical device industry
Ability to work independently, within a group setting, and to interact effectively with different functional departments.
Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
Global experience, or working with market segments preferred
At least 1 year in Regulatory Affairs and Clinical studies.
Knowledge in Understanding the regulatory frameworkExpertise in all Microsoft Office programs including Word, Excel, PowerPoint
Knowledge and proficiency with Project Management tools such as Clarizen and Microsoft project.
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 15,000 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.