Senior Medical Writer

Johnson & Johnson

Warsaw, Indiana, United States of America
Base: $109,000.00 - $174,800.00; bonus/equity: eli...
Fully remote
4+ years professional writing experience
Clinical evaluation report (cer) creation
Regulatory compliance knowledge
Johnson & Johnson is seeking a Senior Medical Writer to join their MedTech Team in Warsaw, Indiana. This fully remote position focuses on creating Clinical Evaluation Reports and supporting regulatory compliance within the orthopedic sector

Job Summary

  • The Senior Medical Writer will provide oversight and execution of Clinical Evaluation Reports, Summary of Safety and Clinical Performance Reports, and Systematic Literature Reviews for the Orthopedics therapeutic area.
  • This role involves mentoring other writers, conducting technical reviews to ensure compliance with J&J guidelines and regulatory requirements, and supporting audits and inspections.
  • Employees are eligible for a comprehensive benefits package including 120 hours of vacation, 480 hours of parental leave, and participation in long-term incentive programs.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Medical Writer to join their MedTech Team in Warsaw, Indiana. This fully remote position focuses on creating Clinical Evaluation Reports and supporting regulatory compliance within the orthopedic sector.

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: 401(k), pension, 120 hours vacation, 480 hours parental leave

Skills & Requirements

Must-have

  • 4+ years professional writing experience
  • Clinical Evaluation Report (CER) creation
  • Regulatory compliance knowledge
  • Technical review and editing skills

Nice-to-have

  • Orthopedics industry background
  • Joint reconstruction or spine expertise
  • Notified Body interaction experience
  • Process improvement initiative participation

Key Requirements

  • Minimum Bachelor's degree required
  • Advanced degree preferred
  • 4 years minimum related professional experience
  • Knowledge of CER regulatory requirements

Work Rights

Not specified

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