Job Description

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Warsaw Indiana United States of America

Job Description:

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 are searching for the best talent for a Senior Medical Writer Scientific Operations to join our MedTech Team. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopedics Ready to join a team thats reimagining how we heal Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at Senior Medical Writer Scientific Operations provides oversite and execution of Clinical Evaluation Reports (CER) Summary of Safety and Clinical Performance Reports (SSCP) State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Orthopedics. They also support broader initiatives and general Scientific Operations activities to support the continuous process improvement activities of the Scientific Operations Team.

Key Responsibilities:

• Planning and writing CERs SSCPs SOAs and LRRs as well as mentoring other writers.
• Conducting technical reviews to ensure document accuracy and compliance with local procedures J&J guidelines and regulatory requirements.
• Managing daily activities to ensure timelines are met.
• Participating in workshops and other initiatives to help define and continuously improve process efficiency.
• Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
• Supports interactions with respective Notified Bodies and regulatory agencies
• Supports audits and inspections pertaining to SciOps processes and deliverables.
• Actively partners with cross-functional business partners such as Medical Directors Post Market Surveillance Design Quality Engineers R&D and Regulatory Affairs
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
• Performs other duties assigned as needed

Qualifications:

Education:

• Minimum of a Bachelors degree and/or University degree is required. Advanced degree is preferred

Experience:

Required:

• A minimum of four (4) years of experience in a related professional environment
• Strong oral communication presentation project management and prioritization skills
• Excellent interpersonal relationships

Preferred:

• Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements evidence generation literature reviews and/or Clinical Evaluation Report (CER) document creation
• Demonstrated knowledge and experience in clinical research quality regulatory compliance adverse event reporting
• Previous experience in orthopedics specifically joint reconstruction and/or spine

Other:

• May require up to 10% domestic and/or international travel to other locations and sites
• This is a remote position

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 internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$109000.00 - $174800.00

Additional Description for Pay Transparency:

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

This position is eligible to participate in the Companys long-term incentive program.

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: - Experience:

Senior IC

Job Tags

Full time, Local area, Immediate start, Remote work

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