Senior Specialist, Medical Writing, Remote US

Edwards Lifesciences Corporation

Job Overview

Location

4 Locations

Job Type

Full-time

Full Job Description

📋 Description

• As a key member of the Clinical Science team, support the development of regulatory and clinical documentation for the Transcatheter Mitral and Tricuspid Therapies (TMTT) portfolio.
• Conduct systematic literature searches using PubMed, Embase, and other databases to identify, extract, and summarize relevant clinical data for clinical evaluation reports and clinical study reports.
• Author routine and moderately complex medical writing deliverables, including clinical evaluation reports, and propose effective approaches for developing more complex documents.
• Review and provide detailed, evidence-based feedback on cross-functional deliverables such as clinical study data, risk management documents, instructions for use (IFUs), and summary safety and effectiveness data (SSED).
• Serve as the primary point of contact for cross-functional stakeholders to negotiate deliverables, timelines, and resolve project-related issues with limited supervision.
• Contribute to continuous process improvements within the medical writing function to enhance efficiency, quality, and compliance.
• Maintain current, in-depth knowledge of Edwards’ TMTT products, including clinical literature, therapeutic developments, and device operation.
• Apply scientific research methodology, Good Clinical Practice (GCP), ICH guidelines, and global regulatory standards (FDA, EU MDR) in all documentation activities.
• Ensure all medical writing outputs comply with MEDDEV 2.7/1 and EU MDR requirements for clinical evaluations and FDA PMA application frameworks.
• Collaborate effectively with R&D engineers, regulatory specialists, physicians, statisticians, and other internal teams to align clinical evidence generation with business and regulatory objectives.
• Demonstrate strict attention to detail in all writing, editing, and data extraction tasks to ensure regulatory compliance and scientific accuracy.
• Utilize MS Word, MS PowerPoint, MS Excel, EndNote, and Adobe Acrobat to prepare, format, and manage clinical documentation and presentations.
• Communicate clearly and professionally across all organizational levels, both orally and in writing, to convey complex scientific and clinical information.
• Work independently while managing multiple, concurrent projects with competing priorities and deadlines.
• Build and maintain productive relationships with internal teams and external partners, including patient advocacy groups and regulatory authorities.
• Apply advanced analytical and scientific writing skills to synthesize clinical data into clear, compelling, and regulatory-ready documents that support patient access to innovative therapies.
• Uphold a patient-first mindset by ensuring all clinical evidence generation directly contributes to improved patient outcomes in mitral and tricuspid valve disease.
• Represent the organization professionally on cross-departmental projects and contribute to team-based initiatives across Clinical Affairs.

🎯 Requirements

• Bachelor’s Degree in a related field with 5 years of experience in medical affairs, clinical affairs, and/or clinical science
• Experience conducting systematic literature reviews using PubMed and Embase
• Experience authoring clinical evaluation reports
• Familiarity with EU MDR (MEDDEV 2.7/1) and FDA PMA application requirements
• Strong knowledge of GCP, ICH guidelines, and global regulatory standards for medical devices
• Demonstrated ability to work independently, prioritize multiple tasks, and manage deadlines in a cross-functional environment

🏖️ Benefits

• Competitive salary with a base pay range of $106,000 to $149,000 for highly experienced candidates
• Performance-based incentive programs
• Comprehensive benefits programs addressing diverse employee and family needs
• Remote work flexibility across the United States

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Edwards Lifesciences Corporation

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About Edwards Lifesciences Corporation

Edwards Lifesciences Corporation, headquartered in Irvine, California, designs, manufactures, and markets medical devices for structural heart disease and critical care monitoring. Founded in 1958 and publicly traded on NYSE:EW, the company pioneered transcatheter aortic valve replacement and offers surgical heart valves, hemodynamic monitoring systems, and advanced catheter-based technologies. Its products serve hospitals and clinicians in more than 100 countries, focusing on improving patient outcomes in cardiovascular care.

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