Senior Writer - MedTech Surgery

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, 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’s reimagining 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.

Your unique talents will help patients on their journey to wellness. 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.

Purpose: The Sr.  Writer provides oversight and execution of Clinical Evaluation Reports/Plans (CER/CEP) and Summary of Safety and Clinical Performance Reports (SSCP). Activities also include oversight and planning of systematic literature reviews for the generation of CERs, Post-Market Surveillance, FDA Reports, and State of the Art (SOA) for Ethicon within J&J Global R&D Medical Device sector.

You will be responsible for:

• 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 associated 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.
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for personal and Company compliance with all Federal, State, local and Company 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.

#LI-Remote

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, 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 Colorado –48 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

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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits