Senior Writer, Scientific Operations
Senior Writer, Scientific Operations
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 105000 - 165000
1 Vacancy
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
Job Function:
R&D OperationsJob Sub Function:
Clinical/Medical OperationsJob Category:
ProfessionalAll Job Posting Locations:
US014 MA Raynham - 325 Paramount Dr US052 OH Cincinnati - 4545 Creek Rd US076 FL Jacksonville - 7500 Centurion Pkwy US121 NJ Raritan - 1000 Highway 202 S US163 TX Irving - 3041 Skyway Circle N US180 CA Irvine - 29A Technology Dr US241 IN Warsaw - 325 Paramount Dr US244 FL Palm Beach Gardens - 4500 Riverside Dr US247 NJ Raritan - 930 US Hwy 202 West Chester Pennsylvania United States of AmericaJob Description:
We 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 The 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.
You will be responsible for:
- 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:
- BA BS or BSN is required; advanced degree is preferred
- Minimum of 5 years of related job experience
- 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 is preferred
- Demonstrated knowledge and experience in clinical research quality regulatory compliance adverse event reporting is preferred
- Strong oral communication presentation project management and prioritization skills
- Excellent interpersonal relationships
- 10% domestic and international travel
- This is a remote position
#LI-AM2
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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$105000-$165000Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. 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 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:Senior IC
Employment Type
Full-Time
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved