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:

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 Medical and Technical Writer, Scientific Operations

As the medical & technical writer within Scientific Operations (SciOps) you will lead the authoring 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. You will also provide input and support to related functions ensuring the delivery of key regulatory and medical documents to gain and retain market access. 

Responsibilities: 

• Write Scientific Operations medical and technical documentation including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Updates Report (PSUR) documents, and other medical and technical assessments based on available data inputs.
• Respond to inquiries from Health Authorities and Notified Body as it pertains to data and information presented in the documents written.  Track and trend inquiries and responses to 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.
• Communicate to drive alignment in strategy across different functions including Medical Affairs, Clinical Research, Quality, R&D, and Regulatory Affairs. 
• Participate in workshops and projects/ initiatives to help define processes improvements. 
• Support audits and inspections pertaining to Scientific Operations processes and reports.

Qualifications:

Required

• Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
• Minimum of 3 years of experience medical device, diagnostics, or pharmaceutical industry with one of those years directly involved with medical devices.
• One year of experience in technical or medical writing, regulatory writing, post market surveillance, clinical research, or product risk management.

Preferred:

• Knowledge of physiology and common outcomes of Neurovascular devices
• An advanced degree, MS, PhD, RN, or MBA.
• Familiarity with the EU MDR regulations as it pertains to clinical evaluations, data sufficiency requirements, and state of the art assessments.