Senior Writer - Medtech Surgery

Johnson & Johnson Innovative Medicine

Raritan, New Jersey, United States of America
Base: $109,000.00 - $174,800.00; bonus/equity: not...
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Clinical evaluation reports/plans
Systematic literature reviews
Post-market surveillance
** Johnson & Johnson is seeking a Senior Writer for their MedTech Surgery division, focusing on creating clinical evaluation reports and overseeing compliance within the medical device sector. The position offers remote work flexibility and requires expertise in clinical research and regulatory documentation. **

Job Summary

  • The Sr. Writer provides oversight and execution of Clinical Evaluation Reports/Plans (CER/CEP) and Summary of Safety and Clinical Performance Reports (SSCP), including planning and oversight of systematic literature reviews.
  • Responsibilities include planning, writing, and reviewing various clinical documents, editing scientific writing for accuracy and compliance, and supporting responses to regulatory bodies.
  • The role requires a Bachelor's Degree with a strong preference for an Advanced Degree and at least 4+ years of experience in the medical device or pharmaceutical industry with knowledge of global clinical evaluation regulatory requirements.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Writer for their MedTech Surgery division, focusing on creating clinical evaluation reports and overseeing compliance within the medical device sector. The position offers remote work flexibility and requires expertise in clinical research and regulatory documentation. **

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Clinical Evaluation Reports/Plans
  • Systematic literature reviews
  • Post-Market Surveillance
  • Summary of Safety and Clinical Performance Reports
  • Medical device regulatory requirements

Nice-to-have

  • Inclusive work environment
  • Continuous process improvement
  • Mentoring junior writers
  • Subject matter authority during audits

Key Requirements

  • Bachelor's Degree required
  • 4+ years of related experience
  • Medical device/pharmaceutical industry experience
  • Knowledge of global clinical evaluation regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter