Edwards Lifesciences

Role Description Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. This position requires travel through the West Coast region. Highly prefer candidates based on the West Coast (CA, OR, AZ, NV, WA). Selected candidate must reside in local region. How you will make an impact: - Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommending and developing process improvements. - Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded. - Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. - Developing and delivering training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. - Contributing to the development of clinical protocols, informed consent forms, and case report forms. - Editing/amending informed consent documents. Qualifications - Bachelor's Degree or equivalent in related field with 3 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria. - Ability to travel up to 75% domestically. Requirements - Clinical research certification (ACRP or SoCRA clinical coordinator/CRA certification) - Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills - Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery - Demonstrated problem-solving and critical thinking skills - Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise - Substantial understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting - Technical writing skills (protocols, CRF development, study tools) - Ability to communicate and relate well with key opinion leaders and clinical personnel Benefits - Competitive salaries - Performance-based incentives - A wide variety of benefits programs to address the diverse individual needs of our employees and their families Company Description For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

• Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead • Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form • Determining if clinical trial/study subject documentation is within parameters of study hypothesis • Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements • Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms • Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities • Acting as a mentor to new or junior level employees • Providing direction and guidance to execute project deliverables in collaboration with project managers • Identifying and evaluating clinical process improvement opportunities • Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence • Participating in the development and validation of case report forms • Reviewing monitoring visit reports • Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees • Reviewing and completing checklist on informed consent forms (ICF)

Role Description Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: - Field monitoring of studies and data collection for clinical trials. - Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determining if clinical trial/study subject documentation is within parameters of study hypothesis. - Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Training and proctoring new employees on trial and study related activities. - Acting as a mentor to new or junior level employees. - Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff. - Supporting study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements. - Contributing to the development of clinical protocols, informed consent forms, and case report forms. - Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. - Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external. - Auditing to ensure the site has the appropriate regulatory documentation to conduct the trial/study. - Ensuring source documentation is properly recorded. - Editing/amending informed consent documents. Qualifications - Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria. - Ability to travel up to 75% domestically. Requirements - Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) (Preferred). - Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills (Preferred). - Demonstrated problem-solving and critical thinking skills (Preferred). - Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery (Preferred). - Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise (Preferred). - Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting (Preferred). - Technical writing skills (protocols, CRF development, study tools) (Preferred). - Ability to communicate and relate well with key opinion leaders and clinical personnel (Preferred). - Experience in training new hires (Preferred). Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. Company Description 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.

• Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks. • Provide clinical expert knowledge, clinical data insights and risk evaluation guidance to Quality Specialists to support complaint assessment, trend identification, regulatory decision-making and potential health risk evaluation within Structural Heart therapies. • Analyze and interpret aggregate complaint, clinical and post-market data for a specific product line, business unit, regulatory submissions, regulatory agency requests and management reports, including trend identification, visualization and ad hoc analytical summaries. • Provide clinical input to Product Risk Assessments (PRA), utilizing complaint data, clinical trends and predictive risk indicators where appropriate. • Support the development and use of AI-enabled tools to enhance complaint evaluation, signal detection and quality decision-making. • Review and interpret relevant imaging information in support of complaint investigations, product quality assessments and risk evaluations. • Develop data visualization tools and dashboards to support quality monitoring, trend detection and management decision-making. • Support Product Safety in development of clinically based training materials and educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks. • Provide medical/clinical guidance and final direction to complaint staff related to event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. • May review complaint conclusions/closure statements and/or customer letters. • May provide training to complaint staff on patient anatomy and medical conditions, products and procedures, and internal policies and procedures. • Provide support in complaint data and relevant clinical information for regulatory submissions or regulatory agency requests. • Mentor, coach, and provide training for other Clinicians Quality Compliance and Quality Specialists. • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution. • Support Product Safety to maintain Decision Rationale Matrix to guide complaint staff and provide final direction on reporting decisions.

Role Description Innovation starts from the heart. Heart valve disease impacts millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our marketing teams build lasting, trusted relationships with medical professionals and industry stakeholders to ensure patients can receive the treatments they need. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. - Collaborate with US Sales Team: Partner with the US sales team and leadership within the assigned geography to strengthen market positioning and support sales growth. - Primary Contact: Serve as the primary contact for designated areas, providing rapid responses, competitive assistance, and connecting with appropriate internal stakeholders and partners. - Build Relationships: Develop relationships with cross-functional partners supporting US field sales (GHER, medical affairs, clinical marketing, therapy development). Guide US sales teams on maximizing the impact of programs and strategies to fortify leadership and growth. - Data Presentation: Understand and present complex data sets and marketing messages to the US field team, customers, and other key stakeholders. - Marketing Representation: Represent the marketing team and provide product expertise at local/regional presentations to diverse audiences. - Collaborate with Marketing Teams: Partner with in-house marketing and collaborate with field marketing colleagues to share best practices and align strategies with organizational objectives. - Training and Messaging: Provide local training and reinforce messaging for strategic growth and marketing initiatives, including product launches, indication changes, and field assets generated by the in-house team. - Event Participation: Attend major meetings and congresses, support the marketing team at key sessions and in the Edwards booth. - Internal Representation: Represent marketing at key internal stakeholder meetings and regional sales meetings and reviews. Qualifications - Bachelor's Degree in a related field with 10 years of experience based on Edwards criteria. - Master's Degree or equivalent in a related field with 8 years of experience working in sales, marketing, or healthcare industry based on Edwards criteria preferred. Requirements - This role is a remote role in the Southwest region of the United States to support our sales team in that location. - Travel 60%. What else we look for (Preferred) - Experience: Downstream marketing and/or sales experience. - Technical Skills: Proven expertise in Microsoft Office Suite. - Communication Skills: Excellent documentation, communication, and interpersonal relationship skills, including negotiating and relationship management, with the ability to drive achievement of objectives. - Expertise: Recognized as an expert in own area with specialized depth within the organization. - Marketing Knowledge: Expert understanding of marketing concepts and principles. - Market Analysis: Ability to assess and understand market share, pricing, ASPs, and competitive dynamics. - Clinical Knowledge: Strong clinical knowledge and experience, particularly in areas where Edwards' products are used or intended to be used. Understand the purchasing process and challenges for product adoption in complex healthcare networks. - Professional Interaction: Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate management levels. - Priority Management: Ability to manage competing priorities in a fast-paced environment. - Project Consultation: Consult in project settings within specific marketing areas. Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. 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.

Role Description This role manages the development and execution of integrated healthcare professional (HCP) media campaigns for the THV business unit at Edwards Lifesciences. This person will demonstrate applied strategy, cross-functional influence, and executional leadership. The Manager plays a key role in audience strategy, channel planning, and campaign management, ensuring media investments drive measurable impact. Join a high-performing, purpose-driven team within Edwards Lifesciences’ Transcatheter Heart Valves (THV) division, where we communicate the life-changing value of our therapies for patients with aortic stenosis. This is an exciting opportunity to contribute to a dynamic Global Brand and Digital Marketing team focused on innovation, impact, and excellence. How you'll make an impact: - Lead media strategy for multiple HCP campaigns, establishing media goals, channel roles, and investment approach, while guiding tactical considerations in partnership with media agency. - Support strategic analyses around HCP audience segmentation, content personalization and deployment (owned and paid), and data amplification. - Drive translating business objectives into actionable media strategies and executional plans, providing clear strategic direction and guardrails while leveraging agency expertise, tools, and platforms. - Oversee campaign activation, ensuring plans are delivered in line with strategic intent and business priorities. - Lead ongoing optimization discussions, providing final decision-making on key investment shifts and in-flight adjustments. - Continuously evaluate and evolve media plans based on performance insights, business shifts, and opportunities surfaced through agency and internal teams. Strategic Partner & Thought Leadership - Build strong, trust-based relationships with cross-functional partners across the THV business unit through consistent collaboration and media expertise. - Serve as a strategic advisor to marketing stakeholders, translating business priorities into clear media direction and recommendations. - Provide guidance on tradeoffs, priorities, and investment strategies to ensure alignment with business goals. - Keep a strong pulse on competitive activity and first-to-market opportunities for HCP activation. - Contribute to the development of media POVs and best practices, informed by campaign learnings and agency insights. - Champion a test-and-learn approach, supporting clear hypotheses, measurement frameworks, and decision-making on scaling successful initiatives. Audience & Channel Strategy - Support development and refinement of HCP audience segmentation, sizing, and targeting strategies grounded in business objectives and available data. - Partner with agency to translate audience frameworks into actionable, platform-ready targeting approaches. - Ensure audience strategies are consistently applied across channels and campaigns. - Contribute to channel selection and investment allocation decisions based on audience insights, objectives, and performance trends. - Identify opportunities to expand reach, improve targeting precision, and unlock new audience growth segments. Campaign Management & Optimization - Oversee in-market campaign performance and partner with agency on optimization strategies. - Monitor budget pacing, delivery, and performance to ensure plans deliver in full and meet KPIs. - Identify opportunities to improve efficiency and effectiveness throughout the campaign lifecycle. Measurement & Reporting - Support implementation of measurement frameworks aligned to business and audience objectives in close collaboration with ELS THV Analytics team. - Analyze campaign leading and lagging performance indicators and synthesize insights into clear, actionable recommendations. Cross Functional Collaboration - Serve as day-to-day contact across marketing, field, global portfolio, digital, analytics, research, finance, and agency partners (media, creative, PR) and represent media across consumer and patient marketing initiatives. - Support planning cadence, including status meetings, finance forecasting, campaign updates, and business reviews. - Ensure clear communication, alignment, and follow-through across stakeholders. - Elevate paid media best practices in creative and messaging discussions, identifying opportunities to strengthen integration across paid, owned, and earned channels. - Partner closely with consumer/patient counterparts to ensure alignment and continuity across HCP and consumer/patient media efforts. - Partner with media and marketing operations team members to ensure timelines, deliverables, processes, MLR requirements, and quality standards are met. - Contribute to improving media processes, tools, and ways of working within the THV business unit. Qualifications - Bachelor's Degree or Equivalent in related field with 8 years of work experience or equivalent work experience based on Edwards criteria Required - Master's Degree or equivalent in related field with 6 years of work experience or equivalent work experience based on Edwards criteria Preferred Requirements - Strong understanding of digital marketing ecosystem including website, content, and CRM. - Experience working on HCP media campaigns, with working knowledge on NPI-based targeting is a plus. - Cardiology specialty experience ideal but not required. - Understanding of ever-changing HCP media vendors and landscape preferred. - Strong understanding of HCP media channels, including digital, social, programmatic, video, EMR, point-of-care, emails, and other professional platforms. - Experience developing clear, insight-driven media briefs that translate business and audience objectives into strategic plans. - Working knowledge of audience targeting, buying strategies, ad ops, media ad tech, campaign measurement (e.g., brand lift, ad effectiveness, incrementality), and optimization approaches. - Strong organizational skills with the ability to manage multiple campaigns simultaneously. - Effective communication and collaboration skills across cross-functional teams and agency partners. - Ability to develop long-term media strategies and can navigate ambiguity, complexity, and business pivots. - Adaptable and open to new ways of working to drive innovation and continuous improvement. - Strict attention to detail. - Adheres to all company policies, procedures, and business ethics codes. - Self-starter with a positive attitude, integrity, and drive to grow. Location This role can be based in Irvine, CA, or Hybrid or Remote. If remote, this person may need to travel to Irvine campus occasionally for key meetings and events. Benefits - Competitive salaries - Performance-based incentives - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. 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.

• Lead the execution and ongoing evolution of European therapy development initiatives focused on patient activation, referrer engagement (CATALYST), and pathway optimization • Partner closely with commercial field teams to strengthen engagement with referring healthcare professionals (HCPs) • Own and continuously optimize HCP engagement strategies • Manage the development, adaptation, and deployment of marketing and educational assets • Drive digital engagement initiatives (e.g., newsletter campaigns and ongoing HCP communication) • Act as a central coordination point across a highly matrixed organization • Serve as a key point of contact for assigned European markets

• Analyze 3D Computed Tomography reconstruction for cases for BU case planning to determine measurement suitability for anatomy for BU implantation. • Provide comprehensive imaging report for case planning purposes. • Perform CT reconstructions that are beyond the scope or experience of the field team in support of case planning to optimize patient outcomes. • Responsible for tracking case planning process through multiple technical platforms in partnership with the analyst, field team, sales operations, information technology, and external stakeholders. • Train field team and/or health care providers on CT and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. • Responsible for entering data for case planning measurements into CRM software. • Identify gaps and provide recommendations on CT acquisition process improvements. • Design and develop training content relevant to image analysis for stakeholders (e.g., field support team and/or health care professionals). • Assist in the execution of quality assurance processes and other process improvements for team members (e.g. field teams). • Participate in knowledge transfer sessions with field team to review challenging cases to identify process improvement optimization.

• Provide strategic leadership and oversight of HR technology initiatives with an emphasis on Workday and associated HR systems. • Act as a strategic partner to the Director, HRIS, while helping shape and scale the broader HR technology ecosystem. • Translate complex business needs into scalable Workday solutions and ensure seamless integration and alignment across current and future HR systems. • Serve as a hands-on expert across Workday modules (Core HCM, Talent, Comp, Integrations). • Lead end-to-end design and configuration, balancing scalability, usability, and compliance. • Define and enforce configuration standards, naming conventions, and design principles. • Anticipate downstream impacts (integrations, reporting, data integrity) and design accordingly. • Ensure Workday design decisions align with broader HR technology architecture and future system integrations.

• Lead and drive the THV clinical training program through curriculum execution, standardization, content development, SME resource management, and documentation to ensure study compliance • Maintain regular contact and collaborate with partner THV clinical teams, cross THV partners, consultants, customers and network appropriately with relevant stakeholders • Develop content as it relates to specialist training topics for best in class practices as they relate to required non-procedural knowledge • Train and evaluate the quality of team members execution of specialist and physician training processes and documentation • Responsible for maintaining an audit ready environment for all aspects of regulatory and non-regulatory audits as it relates to training • Lead assessment of teams’ compliance to GSOPs, work instructions, protocols, LMS and regulatory requirements • Lead audit preparation efforts for THV including team education, process development, timeline management, communication and implementation • Identify, acquire, develop and maintain programs used for electronic documentation records and processes for both internal and external training • Strategically develop and lead the delivery of training programs for THV training on best practices, trends, regulatory requirements and published guidance, policy and procedure updates