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Manager, Project Management (Clinical / Medical / Regulatory Affairs PMO, TMTT)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: May 27, 2023

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Manager, Project Management (Clinical / Medical / Regulatory Affairs PMO, TMTT) page is loaded Manager, Project Management (Clinical / Medical / Regulatory Affairs PMO, TMTT) Apply locations USA - California - Irvine time type Full time posted on Posted Yesterday job requisition id Req-23512
"Helping patients is our life's work, and your contributions directly impact our ability to transform patient care around the world." - Michael A. Mussallem, Chairman and CEO Edwards has a unique opportunity to join the Transcatheter Mitral and Tricuspid Therapies (TMTT) division. As a -Manager in the Clinical, Medical, and Regulatory Affairs Program Management Office, you will lead multiple cross-functional clinical trial programs and teams to plan, execute and -drive business objectives. Work Schedule: This is an onsite position in Irvine, CA. Key Responsibilities:

  • Planning: Develop multi-level, detailed project plans to meet clinical, medical and regulatory objectives based on cross-functional input and analysis.
  • Through multi-level collaboration and influence, gain core team buy-in and team ownership of the plan.
  • Scope: Understanding of product development process, clinical trial milestones, and strategic objectives to drive a successful trial program
  • Determines and discerns requirements on large scale projects to establish program deliverables, and manages changes to the project scope and schedule.
  • Team Leadership: Lead cross-functional core team meetings. Build the following within the team: meeting discipline (agenda, minutes, action items) and team esprit de corps, problem solving culture and accountability.
  • Partner with functional leads, cross-functional team members and other project managers to define/manage resource requirements to support program objectives.
  • Performance measurement and Risk Mitigation: Analyze performance to plan and develop corrective action plans for any variances with the core team. Identify forward looking risk and determine mitigation plans with core leadership team.
  • Communication and Reporting: Maintain weekly status reports, timelines, and program level dashboards
  • Initiate efficient and effective communication, influence strategic discussions drawing on clinical knowledge, and provide clarity for roles and responsibilities to align stakeholders.
  • Serve as conduit between project/team members in all cross-functional groups (e.g. Clinical, Marketing, Ops, Quality, R&D, Regulatory, etc.)
  • Serve as a PMO lead in strategic conversations with senior internal and external personnel on business planning and strategy Basic Qualifications:
    • Bachelor's Degree
    • Minimum 8 years hands on experience in related field, managing mid-to-large scale projects Preferred Qualifications :
      • Master's degree, a minimum of 6 years of experience stated above is required with a Master's degree
      • Clinical trial experience, particularly within the medical device industry
      • Completion of project management training preferred (PMP)
      • Proficient with MS Office Suite and related project management systems
      • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
      • Substantial understanding and knowledge of principles, theories, and concepts relevant to program and portfolio management
      • Ability to adapt to new technologies
      • Ability to adapt to rapid, dynamic, and changing environment
      • Ability to work independently and as an active member and leader of the team
      • Ability to address delicate situations and effectively manage conflict to maximize project team progress
      • Ability to lead and motivate others to action
      • Strong problem-solving, organizational, analytical and critical thinking skills
      • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
      • Effectively communicate orally and in writing to all project stakeholders
      • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $106,000 to $151,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements. Similar Jobs (3) Project Manager (Medical Device) locations USA - California - Irvine time type Full time posted on Posted 16 Days Ago Manager, Imaging Project Management locations USA - California - Irvine time type Full time posted on Posted Yesterday 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 , Manager, Project Management (Clinical / Medical / Regulatory Affairs PMO, TMTT), Executive , Irvine, California

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