Summary of safety and clinical performance reports (sscp)
Systematic literature reviews
Johnson & Johnson is seeking a Senior Writer for their Medtech Surgery team, focusing on Clinical Evaluation Reports and related documentation. The ideal candidate will have experience in the medical device or pharmaceutical industry, with strong communication skills and a background in clinical research
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, mentoring junior writers, and supporting responses to regulatory bodies.
The role requires a Bachelor's Degree, at least 4+ years of related experience in the medical device/pharmaceutical industry, and knowledge of global clinical evaluation regulatory requirements.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Senior Writer for their Medtech Surgery team, focusing on Clinical Evaluation Reports and related documentation. The ideal candidate will have experience in the medical device or pharmaceutical industry, with strong communication skills and a background in clinical research.
Salary
Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Floating Holidays, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off, Pension, 401(k)
Skills & Requirements
Must-have
Clinical Evaluation Reports/Plans (CER/CEP)
Summary of Safety and Clinical Performance Reports (SSCP)
Systematic literature reviews
Scientific writing review and editing
Medical device industry experience
Global clinical evaluation regulatory requirements
Nice-to-have
Mentoring junior writers
Cross-functional team collaboration
Process improvement initiatives
Subject matter authority during audits
Key Requirements
Bachelor's Degree required
4+ years related experience
Medical device/pharmaceutical industry experience
Knowledge of global clinical evaluation regulatory requirements