Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America, Irving, Texas, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  

Remote work options may be considered on a case-by-case basis and if approved by the Company.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Medical and Technical Writer, Scientific Operations

As the medical & technical writer within Scientific Operations (SciOps) you will lead the authoring of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. You will also provide input and support to related functions ensuring the delivery of key regulatory and medical documents to gain and retain market access. 

Responsibilities: 

• Write Scientific Operations medical and technical documentation including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Updates Report (PSUR) documents, and other medical and technical assessments based on available data inputs.
• Respond to inquiries from Health Authorities and Notified Body as it pertains to data and information presented in the documents written. Track and trend inquiries and responses to improve processes and increase speed to market. Translate insights into viable processes and solutions that create value.
• Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.
• Communicate to drive alignment in strategy across different functions including Medical Affairs, Clinical Research, Quality, R&D, and Regulatory Affairs. 
• Participate in workshops and projects/ initiatives to help define processes improvements. 
• Support audits and inspections pertaining to Scientific Operations processes and reports.

Qualifications:

Required

• Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
• Minimum of 3 years of experience medical device, diagnostics, or pharmaceutical industry with one of those years directly involved with medical devices.
• One year of experience in technical or medical writing, regulatory writing, post market surveillance, clinical research, or product risk management.

Preferred:

• Knowledge of physiology and common outcomes of Neurovascular devices
• An advanced degree, MS, PhD, RN, or MBA.
• Familiarity with the EU MDR regulations as it pertains to clinical evaluations, data sufficiency requirements, and state of the art assessments.
• This position can be located remotely or in any one of our MedTech facilities with preferred locations in Irvine, CA.

Additional Information:

• The anticipated base pay range for this position is $109,000 to $148,000.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
  • Caregiver Leave – 10 days
  • Volunteer Leave – 4 days
  • Military Spouse Time-Off – 80 hours
• Additional information can be found through the link below.

This job posting is anticipated to close on November 28, 2025. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource

#LI-Remote

Required Skills:

Clinical Research, Medical Writing, Post Marketing Surveillance, Product Risk Management, Regulatory Writing

 

 

Preferred Skills:

Business Behavior, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Copy Editing, Data Gathering Analysis, Data Savvy, Document Management, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Technical Writing

 

 

The anticipated base pay range for this position is :

$109,000 to $148,000.

Additional Description for Pay Transparency:

Job Tags

Permanent employment, Temporary work, Local area, Immediate start, Remote work,

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