Medical & Technical Writer, Sci Ops - JJMT Electrophysiology
About The Position
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,â¯we believe health is everything. Our strength in healthcare innovation empowers us to build aâ¯world where complex diseases are prevented, treated, and cured,â¯where treatments are smarter and less invasive, andâ¯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.
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.
Nice To Haves
- 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.
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.
Benefits
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's long-term incentive program.
- Employees are eligible for the following time off benefits: 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
