Manager, Project Management, Clinical Affairs, Regulatory Affairs, Medical Affairs - Edwards Lifesciences
Irvine, CA
About the Job
Make a meaningful difference to patients around the world. Our project management teams support many parts of Edwards, including Engineering, HR, Marketing, IT, and more. You’ll be a trusted thought leader as you ensure our projects are completed efficiently and effectively. Your strategic mindset and fresh perspectives will be an essential part of how we bring innovative solutions for patients.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
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.
How you’ll make an impact:
+ Planning: Develop multi-level, detailed project plans to meet clinical, medical and regulatory objectives based on cross-functional input and analysis. Build core team consensus 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 project and program deliverables. Manages changes to the project scope and schedule, anticipates risks, builds various scenarios to drive decision making and agility.
+ 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.
+ 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.
+ Resource Management: Partner with functional leads, cross-functional team members and other project managers to define/manage resource requirements to support program objectives.
+ Communication and Reporting: Maintain weekly status reports, timelines, and program level dashboards. Proactively 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, Finance, Strategy, etc.)
+ Strategy: Serve as a PMO lead in strategic conversations with senior internal and external personnel to inform business planning and strategy, and represent cross-functional team
What you'll need (Required):
+ Bachelor's Degree with minimum 8 years hands on experience required in related field, managing mid-to-large scale projects OR Master’s Degree with 6 years of experience
What else we look for (Preferred):
+ Clinical trial experience, particularly within the medical device industry
+ Completion of project management training (PMP) strongly preferred
+ 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 quickly learn and adapt to new technologies, and dynamic, agile environment and teams
+ Ability to work independently and as an active member and leader of the team
+ Ability to address delicate situations, operate with tact and professionalism, and effectively manage conflict to maximize project team progress
+ Ability to lead, motivate, and inspire teams to action to support business objectives
+ 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 $115,000 to $163,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
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.
How you’ll make an impact:
+ Planning: Develop multi-level, detailed project plans to meet clinical, medical and regulatory objectives based on cross-functional input and analysis. Build core team consensus 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 project and program deliverables. Manages changes to the project scope and schedule, anticipates risks, builds various scenarios to drive decision making and agility.
+ 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.
+ 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.
+ Resource Management: Partner with functional leads, cross-functional team members and other project managers to define/manage resource requirements to support program objectives.
+ Communication and Reporting: Maintain weekly status reports, timelines, and program level dashboards. Proactively 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, Finance, Strategy, etc.)
+ Strategy: Serve as a PMO lead in strategic conversations with senior internal and external personnel to inform business planning and strategy, and represent cross-functional team
What you'll need (Required):
+ Bachelor's Degree with minimum 8 years hands on experience required in related field, managing mid-to-large scale projects OR Master’s Degree with 6 years of experience
What else we look for (Preferred):
+ Clinical trial experience, particularly within the medical device industry
+ Completion of project management training (PMP) strongly preferred
+ 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 quickly learn and adapt to new technologies, and dynamic, agile environment and teams
+ Ability to work independently and as an active member and leader of the team
+ Ability to address delicate situations, operate with tact and professionalism, and effectively manage conflict to maximize project team progress
+ Ability to lead, motivate, and inspire teams to action to support business objectives
+ 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 $115,000 to $163,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Source : Edwards Lifesciences