Medical & Technical Writer, Sci Ops - JJMT Electrophysiology

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:

Irvine, California, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson MedTech, Electrophysiology, is recruiting an Medical & Technical Writer to join our Scientific Operations team.  This role can be located in Irvine, California or Raritan, NJ with a hybrid working schedule of 2-3 days per week on-site.

  

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/.   

  

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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. 

  

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

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 Electrophysiology 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. 

Job 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 e