Johnson and Johnson
Medical and Technical Writer, Scientific Operations
Johnson and Johnson, Irvine, California, United States, 92713
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 https://www.jnj.com
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 https://www.jnj.com/medtech 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 https://www.jnj.com/. 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.
https://www.careers.jnj.com/employee-benefits 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
https://www.careers.jnj.com
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 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 https://www.jnj.com/medtech 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 https://www.jnj.com/. 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.
https://www.careers.jnj.com/employee-benefits 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
https://www.careers.jnj.com
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: