Senior Medical/Technical Writer
About The Position
Johnson & Johnson MedTech, Electrophysiology, is recruiting a Senior Medical/Technical Writer to join our Scientific Operations team. This position can be located remotely or in any one of our MedTech facilities with preferred location in Irvine, CA. 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. 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 Senior 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 provide input and support to related functions ensuring the delivery of key regulatory documents to gain and retain market access. You will also support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.
Requirements
- Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
- Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.
- Knowledge on physiology and common outcomes of electrophysiology.
Nice To Haves
- An advanced degree (MS, RN, PhD, MD).
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 process improvements.
- Support audits and inspections pertaining to Scientific Operations processes and reports.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
