Senior Manager, Medical Writing Job at Edwards Lifesciences Corp in California

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.