Senior Technical Writer
- Scottsdale, Arizona; or Remote, United States
Ethicon is recruiting for a Senior Technical Writer based anywhere in the United States. This is a remote working opportunity.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
This role is responsible for providing oversight and execution of European Union (EU) Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) Reports within the Ethicon businesses.
- Plan and write CERs and SSCPs and mentor junior technical writers.
- Conduct technical reviews to ensure document accuracy and compliance to local procedures, Johnson & Johnson guidelines, and regulatory requirements.
- Partner with cross-functional team members to address the needs of each contributor.
- Manage daily activities to ensure timelines are met.
- Participate in workshops and other initiatives to help define and continuously improve process efficiency.
- Participate in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
- Support and, at times, act as a subject matter authority during audits and inspections pertaining to processes and reports.
BA, BS or BSN is required in areas of Engineering, Nursing, Biomedical Engineering or other life science discipline. An advanced degree is preferred.
Experience and Skills:
- Minimum of 5 years related job experience with a BA, BS or BSN; or minimum of 3 years related job experience with an advanced degree is required.
- Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation is required.
- Strong verbal communication skills and interpersonal relationships is required.
- Demonstrated knowledge and experience in quality regulatory compliance, adverse event reporting, medical device risk management processes, and common statistical methods is preferred.
- Regulatory/Notified Body audit experience is preferred.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
- Primary Location
- United States-Arizona-Scottsdale-15333 N Pima Rd
- Other Locations
- United States
- Medical Device Business Services, Inc (6029)
- Job Function
- Requisition ID