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Senior Specialist, Medical Writing - Job Opportunity at Edwards Lifesciences

Detroit, United States
Full-time
Senior
Posted: April 3, 2025
On-site
USD 106,000 - 149,000 per year

Benefits

Competitive performance-based incentives
Comprehensive benefits package tailored to individual needs
Professional development opportunities in medical device industry
Work with cutting-edge cardiovascular technologies
Collaborative research environment

Key Responsibilities

Lead medical writing initiatives for clinical evaluations and studies in TMTT portfolio
Manage cross-functional stakeholder relationships and project timelines
Conduct and document comprehensive literature reviews and research strategies
Develop technical documentation including risk management reviews and regulatory submissions
Contribute to process improvement initiatives in medical writing

Requirements

Education

Bachelor's Degree with 6 years experience OR Master's degree with 4 years experience OR Doctorate degree with 2 years experience

Experience

2-6 years depending on education level

Required Skills

Scientific research methodology expertise Knowledge of GCP and ICH guidelines Familiarity with FDA PMA applications Advanced MS Office proficiency Strong analytical and problem-solving abilities Professional communication skills Project management capabilities
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Sauge AI Market Intelligence

Industry Trends

The transcatheter mitral and tricuspid therapies sector is experiencing rapid growth with increasing focus on minimally invasive solutions for structural heart disease Regulatory requirements for medical devices are becoming more stringent globally, particularly under EU MDR, creating higher demand for experienced medical writers The convergence of clinical evidence requirements across major markets (US, EU, APAC) is driving the need for standardized documentation approaches

Salary Evaluation

The offered salary range of $106,000-149,000 is competitive for the medical writing specialty in the medical device industry, particularly given the senior level and specialized focus on cardiovascular technologies. Top performers with advanced degrees and regulatory expertise can command higher ranges.

Role Significance

Typically part of a specialized medical writing team of 5-8 professionals within a larger clinical affairs department of 20-30 people
Senior-level position with significant influence on clinical evidence strategy and regulatory submissions. Role carries substantial responsibility for ensuring compliance and scientific validity of clinical documentation.

Key Projects

Clinical evaluation reports for EU MDR compliance FDA PMA submission documentation Clinical trial protocols and reports Publication planning and manuscript development Regulatory response documentation

Success Factors

Deep understanding of cardiovascular medical device regulatory landscape Ability to synthesize complex clinical data into clear scientific narratives Strong project management skills with multiple stakeholder coordination Advanced scientific writing capabilities with attention to regulatory requirements

Market Demand

High demand position due to growing regulatory requirements and expansion of cardiovascular device market. Medical writers with cardiovascular device experience are particularly sought after due to industry specialization and complex regulatory requirements.

Important Skills

Critical Skills

Regulatory documentation expertise - Essential for ensuring compliance and successful submissions Clinical data interpretation - Critical for accurate and meaningful scientific communication Stakeholder management - Key for coordinating complex documentation projects

Beneficial Skills

Experience with specific cardiovascular procedures Knowledge of emerging digital health technologies Publication planning expertise Medical device software documentation experience

Unique Aspects

Specialized focus on transcatheter mitral and tricuspid therapies represents cutting-edge cardiovascular technology
Direct involvement in pioneering medical devices with significant patient impact
Opportunity to shape documentation standards for emerging therapeutic areas

Career Growth

Typical progression to management role within 2-3 years, director level possible within 5-7 years with demonstrated leadership

Potential Next Roles

Medical Writing Manager Clinical Affairs Director Regulatory Affairs Strategy Lead Clinical Evidence Head

Company Overview

Edwards Lifesciences

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease and critical care monitoring

Industry leader in transcatheter heart valve technologies with strong market position in emerging TMTT space
Major presence in Detroit medical device sector with significant R&D and clinical operations
Innovation-driven environment with strong focus on patient outcomes and clinical excellence
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