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:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America, Irving, Texas, United States of America

Job Description:

Job Description

About MedTech

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

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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/. 

Remote work options may be considered on a case-by-case basis and if approved by the Company.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Sr. Writer, Scientific Operations Technical & Medical Writing.

The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Sr. Writer will lead the review of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore, the Sr. Writer will support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.

You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives.  Additionally, you will lead SciOps activities/projects, including those supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR. 

Responsibilities: 

• Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body.

• Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR) documents.

• Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value.

• Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for Scientific Operations deliverables with cross functional business partners.

• Assist in the development of schedules to ensure operating company deliverable timelines are met.

• Participate in workshops and lead projects/ initiatives to help define processes globally and keep abreast of MDR regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures