Medical & Technical Writer, Sci Ops - JJMT Electrophysiology

Medical & Technical Writer, Sci Ops - JJMT Electrophysiology

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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 Med Tech, 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.

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R&D Operations

Clinical/Medical Operations

Professional

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

Johnson & Johnson Med Tech, Electrophysiology, is recruiting a 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.

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

• 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 process improvements.
• Support audits and inspections pertaining to Scientific Operations processes and reports.

• Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
• Minimum of 3 years of experience in 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.

• Knowledge of physiology and common outcomes of electrophysiology.
• 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.

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.

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