Hybrid Medical & Technical Writer, Sci Ops – JJMT Electrophysiology

at OneTrust

• Job title: Medical & Technical Writer, Sci Ops – JJMT Electrophysiology
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $92,000 - $148,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Irvine, United States

About the role

• Medical & Technical Writer at Johnson & Johnson creating medical documentation for the Electrophysiology unit. Involved in Clinical Evaluations, Literature Reviews, and responding to Health Authorities inquiries.

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.

Requirements

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

Benefits

• medical, dental, vision, life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• vacation – up to 120 hours per calendar year
• sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• holiday pay, including Floating Holidays – up to 13 days per calendar year
• work, Personal and Family Time - up to 40 hours per calendar year