Senior Staff Medical Writer (Remote)

Location: Remote - US based candidates only, no visa sponsorship available

About the role

This role will turn data into practical insight that improves visibility, decision-making, and business performance. You will partner with business, technical, and operational stakeholders to build reporting, surface trends, and translate analysis into action. The position offers the opportunity to strengthen data-driven execution and help teams focus on the metrics that matter most within a life sciences environment.

Responsibilities

• Author and maintain essential clinical documentation for regulatory compliance
• Compile and synthesize clinical evidence into submission-ready documents
• Address regulatory feedback to facilitate market access
• Develop evidence strategies and document plans with cross-functional teams
• Draft protocols, reports, and scientific documents for clinical initiatives
• Conduct literature reviews and evaluate scientific data for documentation
• Lead review cycles, coordinating feedback and obtaining necessary approvals

Requirements

• Bachelor's degree in a scientific or technical field
• 6+ years in medical technology or healthcare industry
• 4+ years in medical writing or regulatory documentation activities
• Proven experience with Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documents
• Expert knowledge of EU medical device regulations and associated guidance
• Experience with systematic literature reviews and scientific databases
• Familiarity with FDA regulations and international medical device standards

Benefits

• Remote work flexibility
• Opportunity to mentor junior team members
• Involvement with cross-functional teams across various stages of product lifecycle

Pay

$110,100 – $238,400 annually