Senior Writer, Scientific Operations

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 https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical/Medical Operations

Job Category:

Professional

All 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 America

Job 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, we’re 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 that’s 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 https://www.jnj.com/medtech

Purpose: 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 i