Johnson & Johnson MedTech
Sr. Writer, Scientific Operations Technical & Medical Writing
Johnson & Johnson MedTech, Irvine, California, United States, 92713
Sr. Writer, Scientific Operations Technical & Medical Writing
Join to apply for the
Sr. Writer, Scientific Operations Technical & Medical Writing
role at
Johnson & Johnson MedTech .
Company Overview 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, and where treatments are smarter and less invasive. 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.
Job Summary The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring delivery of key regulatory and medical documents. Specifically, the Sr. Writer will lead the review 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. The role also involves supporting interactions with the Notified Body and applicable Health Authorities, drafting response strategy, forming strategic alliances, and leading SciOps activities/projects such as Eudamed Readiness for SSCP and PSURs under the EU MDR.
Responsibilities
Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and manage submissions to the Notified Body.
Perform technical reviews ensuring accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR).
Track and trend Notified Body inquiries within the business unit to identify trends, improve processes, and increase speed to market.
Ensure Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents to keep information consistent and accessible.
Assist in development of schedules to ensure operating company deliverable timelines are met.
Participate in workshops and lead projects/initiatives to define global processes and keep abreast of MDR regulatory requirements and industry trends.
Support audits and inspections pertaining to Scientific Operations processes and reports.
Partner with cross‑functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.
Qualifications Required
Minimum of a Bachelor’s degree in Life Sciences, Engineering or related subject area.
Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in technical or medical writing, post market surveillance, clinical research, or product risk management.
Preferred
Knowledge of physiology and common outcomes of neurovascular devices.
Experience in the medical device industry and knowledge of clinical evaluation report regulatory requirements.
Advanced degree (MS, PhD, RN, MBA).
Knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management, and biostatistical methods.
Process Excellence / Six Sigma training or certifications.
Remote or Mapped location option, preferred in Irvine, CA.
Compensation & Benefits
Base salary range: $129,000 to $174,000.
Eligible for an annual performance bonus per company guidelines.
Participation in company‑sponsored benefits including medical, dental, vision, life insurance, disability, and retirement plans.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year (56 hours for employees in Washington).
Holiday pay: 13 days per calendar year (Floating Holidays included).
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of 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.
Posting Information This job posting is anticipated to close on November 28, 2025. The Company may extend this time‑period.
Equal Opportunity Statement 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 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.
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Sr. Writer, Scientific Operations Technical & Medical Writing
role at
Johnson & Johnson MedTech .
Company Overview 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, and where treatments are smarter and less invasive. 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.
Job Summary The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring delivery of key regulatory and medical documents. Specifically, the Sr. Writer will lead the review 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. The role also involves supporting interactions with the Notified Body and applicable Health Authorities, drafting response strategy, forming strategic alliances, and leading SciOps activities/projects such as Eudamed Readiness for SSCP and PSURs under the EU MDR.
Responsibilities
Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and manage submissions to the Notified Body.
Perform technical reviews ensuring accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR).
Track and trend Notified Body inquiries within the business unit to identify trends, improve processes, and increase speed to market.
Ensure Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents to keep information consistent and accessible.
Assist in development of schedules to ensure operating company deliverable timelines are met.
Participate in workshops and lead projects/initiatives to define global processes and keep abreast of MDR regulatory requirements and industry trends.
Support audits and inspections pertaining to Scientific Operations processes and reports.
Partner with cross‑functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.
Qualifications Required
Minimum of a Bachelor’s degree in Life Sciences, Engineering or related subject area.
Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in technical or medical writing, post market surveillance, clinical research, or product risk management.
Preferred
Knowledge of physiology and common outcomes of neurovascular devices.
Experience in the medical device industry and knowledge of clinical evaluation report regulatory requirements.
Advanced degree (MS, PhD, RN, MBA).
Knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management, and biostatistical methods.
Process Excellence / Six Sigma training or certifications.
Remote or Mapped location option, preferred in Irvine, CA.
Compensation & Benefits
Base salary range: $129,000 to $174,000.
Eligible for an annual performance bonus per company guidelines.
Participation in company‑sponsored benefits including medical, dental, vision, life insurance, disability, and retirement plans.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year (56 hours for employees in Washington).
Holiday pay: 13 days per calendar year (Floating Holidays included).
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of 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.
Posting Information This job posting is anticipated to close on November 28, 2025. The Company may extend this time‑period.
Equal Opportunity Statement 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 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.
#J-18808-Ljbffr