Edwards Lifesciences Senior Manager, Medical Writing, Podium Publications – Transcatheter Heart Valve (REMOTE position) in Irvine, California
*Remote-based position with estimate 25% travel.
Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally invasive solutions for patients suffering from structural heart disease. As the Senior Manager, Medical Writing supporting the THV division, you will serve as a medical writer and lead a team of subject matter experts to create abstracts, manuscripts, and presentations that effectively and clearly describe clinical trial methodology, data, product use, and relevance. You will ensure that publications and presentations comply with Quality Systems Regulations and applicable regulatory, journal, and other guidelines in terms of content, format and structure.
Lead the timely and successful development of high-quality manuscripts, abstracts, and posters, including medical writing, editing, finalizing, and submitting content to scientific congresses and medical journals, to support Edwards Lifesciences’ transcatheter heart valve scientific communication plan.
Work collaboratively with study investigators to develop manuscripts, podium presentations, and posters for publication or presentation at interventional cardiology and cardiothoracic surgery conferences.
Comply with Quality System Regulations and relevant guidelines for scientific publications, including but not limited to ICMJE and GPP3.
Assist with Scientific Publications Office (SPO) communication strategy development and documentation.
Work collaboratively with cross-functional teams, including regulatory, research and development, biostatistics, clinical safety, and marketing to achieve publication and communication goals.
Actively represent SPO during clinical trial core team meetings, providing clear and timely communication to cross-functional partners about clinical trial-specific publication and podium plans.
Work collaboratively with clinical research teams, including data mining, compiling, analyzing, and summarizing data for primary and secondary publication and podium projects.
Maintain current, in-depth product knowledge, including current developments, clinical literature, and therapeutic and product usage knowledge.
Apply scientific principles, theories, and concepts in developing communication projects.
Track projects and provide project-related updates to internal and external customers.
Ability to work with global partners and advisors.
Post-graduate training (MS or PhD) in medical or scientific field.
Demonstrated track record in people management.
Professional medical writing experience, including clinical data analysis, publication development, and publication project management.
Cardiovascular medical device industry experience highly preferred.
Must have at least a working understanding of interventional cardiology (coronary or structural heart) or have expert clinical experience or clinical trial experience that fulfills this requirement.
Expert understanding and application of GPP3 requirements, ICMJE recommendations, ICH guidelines, and Quality Systems Regulations.
Excellent written, oral, and presentation skills.
Expert knowledge of MS Word, Excel, and PowerPoint.
Expert ability to conduct PubMed literature searches
Ability to comprehend high-level scientific documentation, including statistical tables and medical literature.
Must be assertive, persistent, detail-oriented, and have strong organizational skills.
Experience working effectively with healthcare professionals.
Exceptional interpersonal skills for working in cross-functional teams with R&D engineers, regulatory specialists, project managers, marketing professionals, biostatisticians, and support personnel.
Ability to read, write, and speak English fluently.
Overnight travel across the US and internationally for professional meetings is required.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.