Edwards Lifesciences Medical Writing Specialist - Transcatheter Heart Valve (USA Remote Position) in Irvine, California
Edwards is the global leader in transcatheter heart valve replacement technologies designed for the nonsurgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in 2007, and in the United States in 2011, our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world.
The Medical Writing Specialist will act as a primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines
Essential Job Functions & Key Responsibilities :
Develop medical writing documents/deliverables for assigned project(s) (e.g., IDE annual reports, Clinical Study Reports, etc.)
Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders
Conduct literature searches and reviews including developing search strategy, manage associated documentation, and prepare literature summaries
Provide input on other cross-functional deliverables utilizing technical knowledge
Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
Other incidental duties assigned by Leadership
Minimum Requirements :
Bachelor's Degree with 3 years of medical writing experience; or MS/PhD degree with relevant graduate research or post-doc experience
Familiarity and/or experience with literature searches and reviews for PubMed; and reference management software (e.g. EndNote or Distiller)
Advanced user of MS Word (e.g., formatting, templates).
Preferred Qualifications :
MS or PhD degree
Medical Device, Pharma, or Biotech industry experience
Experience in cardiology or interventional cardiology therapeutic areas
Knowledge of FDA regulations or MedDev/EU MDR regulations
Additional Talents & General Expectations :
Ability to travel up to 10% of the time to conferences and/or to our Irvine, CA corporate office
Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific content and medical writing
Strict attention to detail
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 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.