Senior Medical/Technical Writer
Johnson & Johnson, 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 preferred location in Irvine, CA.
Clinical operations and regulatory documentation support for the MedTech Electrophysiology business unit, including the authoring of Clinical Evaluations, State of the Art Assessments, Literature Reviews, Summaries of Safety and Clinical Performance, and Periodic Safety Updates. You will provide input and support to related functions ensuring the delivery of key regulatory documents to gain and retain market access and support interactions with the Notified Body and applicable Health Authorities.
Job Function: R&D Operations
Job Sub Function: Clinical/Medical Operations
Job Category: Professional
All Job Posting Locations: Irvine, California, United States of America
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) 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.
Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS, etc.) to ensure information consistency and accessibility.
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 process improvements.
Support audits and inspections pertaining to Scientific Operations processes and reports.
Qualifications
Minimum of a Bachelor’s degree (University 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 the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.
Knowledge of physiology and common outcomes of electrophysiology.
Advanced degree (MS, RN, PhD, MD) preferred.
Preferred Skills
Analytical Reasoning
Clinical Operations
Clinical Research and Regulations
Clinical Trial Designs
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
Compensation and Benefits $109,000.00 - $174,800.00
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington)
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 (10 days)
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
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Clinical operations and regulatory documentation support for the MedTech Electrophysiology business unit, including the authoring of Clinical Evaluations, State of the Art Assessments, Literature Reviews, Summaries of Safety and Clinical Performance, and Periodic Safety Updates. You will provide input and support to related functions ensuring the delivery of key regulatory documents to gain and retain market access and support interactions with the Notified Body and applicable Health Authorities.
Job Function: R&D Operations
Job Sub Function: Clinical/Medical Operations
Job Category: Professional
All Job Posting Locations: Irvine, California, United States of America
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) 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.
Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS, etc.) to ensure information consistency and accessibility.
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 process improvements.
Support audits and inspections pertaining to Scientific Operations processes and reports.
Qualifications
Minimum of a Bachelor’s degree (University 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 the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.
Knowledge of physiology and common outcomes of electrophysiology.
Advanced degree (MS, RN, PhD, MD) preferred.
Preferred Skills
Analytical Reasoning
Clinical Operations
Clinical Research and Regulations
Clinical Trial Designs
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
Compensation and Benefits $109,000.00 - $174,800.00
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington)
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 (10 days)
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
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