Senior Analyst, Medical Writing, Clinical & Reg... @ Johnson & Johnson MedTech
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About Johnson & Johnson MedTech
At Johnson & Johnson, we believe health is everything. Our healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured through smarter, less invasive, and personalized solutions. Learn more at jnj.com.
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, the Cardiovascular team develops next-generation treatments for heart recovery, electrophysiology, and stroke. This role contributes to elevating standards of care for stroke, heart failure, and atrial fibrillation patients. Explore more at jnj.com/medtech.
Role Overview
The Senior Analyst, Medical Writing, Clinical & Regulatory Affairs will support clinical evaluation activities within the Clinical and Regulatory Affairs department by planning and preparing regulatory documents. The role involves direct influence on submissions and updates. You will be responsible for global post-market surveillance documents, including clinical evaluation plans, reports, post-market surveillance plans, SSCP, and PMCF documents.
Key Responsibilities
- Plan, prepare, and finalize global regulatory documents (US & EU).
- Conduct literature and clinical data reviews for submissions.
- Collaborate cross-functionally on document planning and reviews.
- Ensure all documentation meets FDA, EMA, and company standards.
- Stay updated with regulatory guidelines and industry trends.
- Opportunity to expand writing capabilities in other areas.
Qualifications
- Bachelor’s degree required; advanced science degree preferred.
- Minimum 4 years scientific/med tech experience; clinical research is a plus.
- At least 3 years of relevant medical writing experience; cardiovascular experience preferred.
- Expertise in authoring CERs, post-market surveillance plans, SSCPs, and PMCFs.
- Deep understanding of FDA and EU MDR regulations.
- Excellent communication and precise documentation skills.
Additional Information
Johnson & Johnson is an Equal Opportunity Employer committed to inclusiveness. Applicants with disabilities needing accommodations during the interview process can contact the company through the provided channels.
Compensation & Benefits
Base pay range: $91,000-$147,200. Additional benefits include medical, dental, vision, life insurance, retirement plans, paid time off, and more. For detailed information, visit the careers page.
Work Location
This is a remote role available in the continental USA, with primary reference to Danvers, Massachusetts.
Key skills/competency
- Regulatory
- Clinical Evaluation
- Medical Writing
- Post-Market Surveillance
- Cross-functional Collaboration
- FDA
- EMA
- Data Review
- Compliance
- Documentation
How to Get Hired at Johnson & Johnson MedTech
🎯 Tips for Getting Hired
- Customize your resume: Highlight relevant regulatory experience and skills.
- Research Johnson & Johnson: Understand their medtech innovation and values.
- Emphasize medical writing: Showcase expertise in regulatory documents.
- Prepare for interviews: Review clinical evaluation and compliance topics.