Edwards Lifesciences develops patient-focused medical technologies for cardiovascular care. Its portfolio includes transcatheter heart valves, surgical valve solutions, mitral and tricuspid therapies, and critical care systems for hemodynamic, remote, and predictive monitoring. The company also conducts clinical research and supports healthcare innovation aimed at improving outcomes for people living with cardiovascular disease. Hiring may span medical technology, clinical research, engineering, critical care, and related corporate functions.
Senior Medical Writing Specialist — Remote in Mississippi
Lead medical writing activities for clinical evidence and regulatory submissions supporting Edwards Lifesciences’ transcatheter heart valve technologies. Manage literature reviews, complex deliverables, and collaboration across clinical, regulatory, and business teams.
United States
Mississippi$108,000 – $153,000 / year
RemoteFull-timeSeniorEnglish RequiredContent WriterDescription
- Prepare complex medical writing documents and deliverables, contributing to project-specific templates.
- Lead negotiations on deliverables and timelines while resolving issues with cross-functional stakeholders.
- Plan and conduct literature searches and reviews, maintain supporting documentation, and produce literature summaries.
- Represent the medical writing team in meetings covering reporting plans and regulatory submissions for clinical studies in the United States, European Union, and other international markets.
- Lead or support complex cross-functional work, including risk management reviews, instructions for use, and summary of safety and clinical performance documents.
- Guide, train, and mentor medical writers with less experience.
- Recommend and help implement ongoing improvements to medical writing processes.
- Serve as the main contact for medical writing projects and coordinate internal and external timelines with Edwards teams and clients.
Requirements
- Bachelor’s degree in a related field plus five years of medical writing experience, or equivalent work experience under Edwards’ criteria.
- Experience developing clinical evaluation reports under MEDDEV 2.7/1 Rev. 4 and/or the European Union Medical Device Regulation.
- Advanced proficiency with Microsoft Word, Excel, and PowerPoint.
- Experience using publication management software such as EndNote and research databases such as PubMed.
- Strong written and verbal communication, including customer negotiation and relationship management.
- Strong problem-solving, organizational, analytical, and critical-thinking abilities.
- Comprehensive understanding of the policies, procedures, and guidelines governing scientific content and medical writing.
- Demonstrated leadership and the ability to influence change.
- Exceptional attention to detail.
- Professional communication skills across all organizational levels.
- Ability to manage competing priorities in a fast-paced setting.
- Ability to collaborate within teams, including interdepartmental groups and project contacts representing the organization.
Benefits
- Competitive salary offerings.
- Performance-based incentive opportunities.
- A broad benefits portfolio designed to support the varying needs of employees and their families.