Edwards Lifesciences

Oversee medical writing projects supporting clinical and regulatory submissions, manage team performance, and collaborate with cross-functional teams to ensure high-quality deliverables. | Bachelor's degree, experience in medical writing and clinical data analysis, demonstrated leadership in team management, knowledge of regulatory requirements, and experience in regulated industries. | 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 undertreated. 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. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. How you'll make an impact: Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams Review and interpret study data analyses Contribute to the generation of product life cycle plans (e.g., post-market surveillance). What you'll need (Required): Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria Demonstrated track record in people management or equivalent work experience based on Edwards criteria What else we look for (Preferred): Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria Medical writing or regulatory certification or equivalent work experience based on Edwards criteria Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria Experience working in a regulated industry or equivalent work experience based on Edwards criteria Certification in related fields Strong leadership in project and team management, including coaching and performance oversight. Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. Familiarity with coronary interventional and structural heart environments. Proven ability to develop metrics demonstrating medical writing value to the business. Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. 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 $142,000 to $201,000 (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. 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. 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.

Lead and manage sales teams to expand the company's transcatheter mitral and tricuspid therapies across a US region, including strategy development, talent management, and cross-department collaboration. | Bachelor's degree or equivalent, proven regional management experience, and success in sales within the cardiovascular or interventional vascular device industry. | 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. As a Regional Director, you will lead commercialization and expansion of groundbreaking therapies in our Transcatheter Mitral & Tricuspid Business Unit (TMTT). As a member of the sales leadership team, the Regional Sales Director will be responsible for the Transcatheter Mitral & Tricuspid (TMTT) business across a US Region. This role reports to an Area Vice President and will drive the achievement of sales and profit objectives within a region of responsibility, to include overall coordination, management & development of sales teams (Territory Managers and Field Clinical Specialists). This position will drive sales strategy and manage a team based out of a Southern CA region. How you will make an impact: Responsible for coordinating and executing specific objectives of the sales strategy Establishes sales targets, manages budget and inventory in partnership with Sales Operations team Talent management responsibilities: hiring, developing, retaining talent and developing succession plans, proactively managing performance Collaborates with functional departments of the company, specifically but not limited to Operations, Finance, Marketing, Human Resources, R&D, Regulatory Affairs, Medical Affairs, and Clinical Affairs Oversight of site performance and outcomes Plans and prepares forecasts by account, product and therapy for the given territory as well as proposed expenses for meetings and/or customer activities Proactively facilitates the flow of information from the field into Business Development, Marketing and R&D Collaborates with Marketing and Professional Education to further develop value added strategies, tools, programs and services Maintains current knowledge of competitive business strategies and product pipeline, healthcare economics, regulatory and legislative activities and incorporate into regional sales plans and strategies Manage and adhere to T&E expense budget, inventory management, and other variable expenses such as regional sponsorships, grants and COE What you’ll need (Required): Bachelors or equivalent in related field plus experience in operations management at regional level required or equivalent work experience based on Edwards criteria required. Demonstrated track record of direct people management or equivalent work experience based on Edwards criteria required. Ability to travel 60% (including car, air and overnight travel) What else we look for (Preferred): Previous people leadership experience including building and managing high performing teams strongly preferred Proven record of success in sales within the cardiovascular or interventional vascular device industry highly preferred Demonstrated change agent with a bias for action. Open to exploring and being influenced by differing ideas and points of view Ability to provide strategic input back to Marketing, Sales, R&D, Operations, etc. Knowledge of the TMTT products/therapies and/or aptitude to gain an extensive understanding of all their applications A record of accomplishment of introducing new products to market, managing costs, budgeting, developing sales forecasting methods, and driving adoption of new therapies exemplified by meeting sales targets. Demonstrated skills in the following areas: coaching and counseling, budgeting, negotiating, marketing, selling and strategic planning Must have strong strategic, analytical, and financial skills with a demonstrated ability to understand competition and industry trends Proficient skills in Microsoft Office Suite (Outlook, PowerPoint, Excel, Teams, etc.) 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 (CA), the base pay range for this position is $147,000 to $173,000 (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. 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. 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.

Design, implement, and technically own the enterprise LIMS system, manage platform roadmap, ensure compliance and security, and lead global IT transformation efforts. | Bachelor's degree, 10+ years IT experience, professional architecture certification, hands-on LIMS experience, regulatory knowledge, server and database skills, and strong communication in a global matrix environment. | Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions. The IT Senior Application Architect, LIMS, will serve as the technical owner of our enterprise Laboratory Information Management System (LIMS) reporting to the Director, IT Business Partner of Global Quality and Lab Technologies. As the IT Senior Application Architect, LIMS, you will be a key member of a global quality technical transformation team implementing and guiding the technical evolution and optimization of LIMS across a global organization. How you’ll make an impact: • Design and implement LIMS technical solutions to meet business requirements. • Oversee all technical delivery for LIMS and assume technical ownership of the system. • Define and implement IT LIMS standards, ensuring alignment with global IT and industry best practices for software development and system implementation. • Manage the technical platform roadmap, including regular platform updates and prompt resolution of IT security vulnerabilities within established SLAs. • Advocate for remediation of technical debt and continuous system improvements to drive business growth and development. • Partner with business leaders to understand organizational needs and assess implementation complexity for both in-house and project-funded initiatives. • Act as a steward for LIMS integrity, making informed recommendations to minimize unnecessary customization and preserve system purpose. • Execute a shift-left strategy for support and maintenance, transferring Level 2 (L2) support to the global team while retaining Level 3 (L3) support, problem management, and change management within the transformation team. What you'll need (Required): • Bachelor's Degree in Computer Science, Information Systems, Natural Sciences & Mathematics or a related discipline • A minimum of ten years experience in IT • A professional certification (e.g. TOGAF, COBIT, ITIL, OCP, CDMP, etc.) in related disciplines and architecture frameworks What else we look for (Preferred): • Hands-on experience designing, configuring, implementing, and maintaining enterprise LIMS with a preference toward direct experience with LabWare and LabVantage • Experience working with 21 CFR part 11. • Experience working with in a regulated environment, and strong understanding of GxP concepts and regulatory compliance in a pharmaceutical/medical device setting. • Experience with commercial off the shelf applications and a solid understanding of the importance master data structure plays in a scalable enterprise solution. • Experience writing and executing validation deliverables (e.g., IQ/OQ/SDD) in the software development life cycle (SDLC) for validated, regulated, applications. • Strong background in server-client and/or web hosted application architecture, integrations to applications and equipment; preference for experience with laboratory instruments and enterprise systems (such as ERP and MES). • Experience with server administration required to support an enterprise application. • Experience with structured query language (SQL) and relational databases. • Experience / knowledge with remote desktop and other web hosting platforms. • Experience working with application vendors, and 3rd party consulting companies on technology implementations and delivery. • Comfortable communicating and presenting ideas/recommendations to a senior leadership level. • Experience working in a global, highly matrix, and team-oriented IT environment. • High energy, self-motivation, and results-driven mindset with an excitement to learn new technologies. • Have a passion for our mission at Edwards Lifesciences. If you are passionate about advancing laboratory information management, thrive in collaborative global teams, and want to make a significant impact on business and IT transformation, we invite you to apply. 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 (CA), the base pay range for this position is $136,000 to $192,000 (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. 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.