Associate Manager, Program Management
Company: Edwards Lifesciences Gruppe
Posted on: February 23, 2021
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account. Thank you for your patience. 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
- 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
- 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
- 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
- Define and organize workstream activities for the project and
- Ensure resource availability and allocation for workstream
- 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
- 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
- Leverage well developed interpersonal skills to build and
maintain positive working relationships with customers and key
- Develop tools and metrics to use across projects for future
launches MINIMUM QUALIFICATIONS
- Bachelor's degree preferably in a scientific field; advanced
- 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
- 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
- At least 1 year in Regulatory Affairs and Clinical
- Knowledge in Understanding the regulatory framework
Expertise in all Microsoft Office programs including Word, Excel,
- Knowledge and proficiency with Project Management tools such as
Clarizen and Microsoft project.
- PMP certificate E dwards is an Equal Opportunity/Affirmative
Action employer including protected Veterans and individuals with
disabilities. Posted 3 Days Ago Full time Req-6407 About Us 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Associate Manager, Program Management, Executive , Irvine, California
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