Senior Medical/Technical Writer
Johnson & Johnson MedTech, Irvine, CA, United States
Johnson & Johnson MedTech, Electrophysiology, is recruiting a
Senior Medical/Technical Writer
to join our Scientific Operations team. This position can be located remotely or in any one of our MedTech facilities with a preferred location in Irvine, CA.
Job 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) and other assessments based on available data.
Respond to inquiries from Health Authorities and Notified Body relating to data and information presented in the documents; track and trend inquiries and responses to improve processes and increase speed to market.
Ensure deliverables are linked to appropriate Quality Systems and regulatory documents such as Risk Management and Post Market Surveillance to guarantee consistency and accessibility.
Communicate to drive alignment across Medical Affairs, Clinical Research, Quality, R&D, and Regulatory Affairs.
Participate in workshops and projects that help define process improvements.
Support audits and inspections pertaining to Scientific Operations processes and reports.
Qualifications
Minimum of a Bachelor’s degree in Life Sciences, Engineering or related subject area.
Minimum of 5 years in a regulated environment, including at least 3 years of direct experience with medical devices in technical or medical writing, post‑market surveillance, clinical research, or product risk management.
Knowledge of physiology and common outcomes of electrophysiology.
An advanced degree (MS, RN, PhD, MD) is preferred.
Base Pay Range $109,000.00 – $174,800.00
Benefits Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (State of Colorado 48 hours; State of Washington 56 hours)
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
Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52‑week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
Preferred Skills Analytical Reasoning, Clinical Operations, Clinical Research, Regulations, Clinical Trial Design, Coaching, Communication, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Innovation, Laboratory Operations, Office Administration, Problem Solving, Project Schedule, Research and Development, Researching, Study Management.
EEO 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. We are committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees may contact AskGS for accommodation resources.
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Senior Medical/Technical Writer
to join our Scientific Operations team. This position can be located remotely or in any one of our MedTech facilities with a preferred location in Irvine, CA.
Job 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) and other assessments based on available data.
Respond to inquiries from Health Authorities and Notified Body relating to data and information presented in the documents; track and trend inquiries and responses to improve processes and increase speed to market.
Ensure deliverables are linked to appropriate Quality Systems and regulatory documents such as Risk Management and Post Market Surveillance to guarantee consistency and accessibility.
Communicate to drive alignment across Medical Affairs, Clinical Research, Quality, R&D, and Regulatory Affairs.
Participate in workshops and projects that help define process improvements.
Support audits and inspections pertaining to Scientific Operations processes and reports.
Qualifications
Minimum of a Bachelor’s degree in Life Sciences, Engineering or related subject area.
Minimum of 5 years in a regulated environment, including at least 3 years of direct experience with medical devices in technical or medical writing, post‑market surveillance, clinical research, or product risk management.
Knowledge of physiology and common outcomes of electrophysiology.
An advanced degree (MS, RN, PhD, MD) is preferred.
Base Pay Range $109,000.00 – $174,800.00
Benefits Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (State of Colorado 48 hours; State of Washington 56 hours)
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
Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52‑week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
Preferred Skills Analytical Reasoning, Clinical Operations, Clinical Research, Regulations, Clinical Trial Design, Coaching, Communication, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Innovation, Laboratory Operations, Office Administration, Problem Solving, Project Schedule, Research and Development, Researching, Study Management.
EEO 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. We are committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees may contact AskGS for accommodation resources.
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