Senior Writer - MedTech Surgery
Johnson & Johnson MedTech, Raritan, NJ, United States
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, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are positioned to innovate across the full spectrum of healthcare solutions to deliver breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us around the world. We provide an inclusive work environment where each person is considered an individual. We respect the diversity and dignity of our employees and recognize their merit.
Job Function R&D Operations
Job Sub Function Clinical/Medical Operations
Job Category Professional
All Job Posting Locations Raritan, New Jersey, United States of America, Remote (US)
Job Description
About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that reimagines how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a
Senior Writer
to support our Surgery business. Remote work options may be considered on a case-by-case basis and if approved by the Company. There is a strong preference for candidates in Eastern or Central time zones.
Responsibilities
Planning, writing, and reviewing CEPs, CERs (including State of the Art protocols and reviews), Literature reports, and SSCPs
Reviewing and editing scientific writing to ensure document accuracy and compliance to local procedures, J&J guidelines and regulatory requirements
Mentoring junior writers
Supporting responses to queries from regulatory bodies (e.g. Notified Bodies)
Utilizing software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, Readcube)
Advising on project-specific software tool designs (e.g., data management systems) to house clinical study data from literature
Partnering with cross-functional team members to address needs of each contributor
Leading daily activities to ensure timelines are met
Participating in workshops and other initiatives to help define and continuously improve process efficiency
Participating in continuing education activities to improve understanding of regulatory requirements and industry trends/practices
Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports
Communicating business-related issues or opportunities to next management level
If supervising staff, ensuring subordinates follow Company health, safety and environmental guidelines and that resources are available and in good condition
Responsible for personal and Company compliance with all applicable regulations, policies, and procedures
Performs additional assigned duties as needed
Qualifications / Requirements
Minimum of a Bachelor’s Degree is required; Advanced Degree is strongly preferred
At least 4+ years of related experience is required
Experience within the medical device and/or pharmaceutical industry and knowledge of global clinical evaluation regulatory requirements, document creation, and associated evidence generation is required
Strong verbal communication skills and interpersonal relationships
Proven knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred
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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Compensation & Benefits
Required Skills and Preferred Skills are described; anticipated base pay range is $109,000.00 - $174,800.00
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s retirement plan (pension) and savings plan (401(k))
Benefits include time off such as Vacation, Sick time, Holidays, Work/Pers on time-off, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, and Military Spouse Time-Off as described by policy
Note: For additional general information on Company benefits, please visit https://www.careers.jnj.com/employee-benefits.
#J-18808-Ljbffr
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us around the world. We provide an inclusive work environment where each person is considered an individual. We respect the diversity and dignity of our employees and recognize their merit.
Job Function R&D Operations
Job Sub Function Clinical/Medical Operations
Job Category Professional
All Job Posting Locations Raritan, New Jersey, United States of America, Remote (US)
Job Description
About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that reimagines how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a
Senior Writer
to support our Surgery business. Remote work options may be considered on a case-by-case basis and if approved by the Company. There is a strong preference for candidates in Eastern or Central time zones.
Responsibilities
Planning, writing, and reviewing CEPs, CERs (including State of the Art protocols and reviews), Literature reports, and SSCPs
Reviewing and editing scientific writing to ensure document accuracy and compliance to local procedures, J&J guidelines and regulatory requirements
Mentoring junior writers
Supporting responses to queries from regulatory bodies (e.g. Notified Bodies)
Utilizing software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, Readcube)
Advising on project-specific software tool designs (e.g., data management systems) to house clinical study data from literature
Partnering with cross-functional team members to address needs of each contributor
Leading daily activities to ensure timelines are met
Participating in workshops and other initiatives to help define and continuously improve process efficiency
Participating in continuing education activities to improve understanding of regulatory requirements and industry trends/practices
Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports
Communicating business-related issues or opportunities to next management level
If supervising staff, ensuring subordinates follow Company health, safety and environmental guidelines and that resources are available and in good condition
Responsible for personal and Company compliance with all applicable regulations, policies, and procedures
Performs additional assigned duties as needed
Qualifications / Requirements
Minimum of a Bachelor’s Degree is required; Advanced Degree is strongly preferred
At least 4+ years of related experience is required
Experience within the medical device and/or pharmaceutical industry and knowledge of global clinical evaluation regulatory requirements, document creation, and associated evidence generation is required
Strong verbal communication skills and interpersonal relationships
Proven knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred
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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Compensation & Benefits
Required Skills and Preferred Skills are described; anticipated base pay range is $109,000.00 - $174,800.00
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s retirement plan (pension) and savings plan (401(k))
Benefits include time off such as Vacation, Sick time, Holidays, Work/Pers on time-off, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, and Military Spouse Time-Off as described by policy
Note: For additional general information on Company benefits, please visit https://www.careers.jnj.com/employee-benefits.
#J-18808-Ljbffr