Senior Technical Writer

$45,000 - $62,000/Yr

Unclassified - Pierre, SD

Full-time - Senior

Pierre, SD

About the position

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. 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, we deliver innovation to make a life-changing impact. The Senior Technical Writer provides oversight and execution of European Union (EU) Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) Reports within the Ethicon businesses. This role involves planning and writing CERs and SSCPs, mentoring junior technical writers, conducting technical reviews to ensure document accuracy and compliance with local procedures, Johnson & Johnson guidelines, and regulatory requirements. The Senior Technical Writer will partner with cross-functional team members to address the needs of each contributor, manage daily activities to ensure timelines are met, and participate in workshops and other initiatives to help define and continuously improve process efficiency. Additionally, the role includes participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices, and supporting audits and inspections pertaining to processes and reports.

Responsibilities

• Plan and write Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCPs).
• Mentor junior technical writers.
• Conduct technical reviews to ensure document accuracy and compliance with 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 initiatives to improve process efficiency.
• Engage in continuous education activities to enhance understanding of regulatory requirements and industry trends.
• Support and act as a subject matter authority during audits and inspections.

Requirements

• Bachelor's degree with a minimum of 5 years of related experience.
• Minimum of 3 years related Clinical Evaluation Report (CER) writing experience.
• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation is required.
• Strong written and verbal communication skills.
• Demonstrated ability to team well with other employees.

Nice-to-haves

• Master's degree in areas of Engineering, Nursing, Biomedical Engineering, or other life science discipline.
• Bachelor's degree in areas of Engineering, Nursing, Biomedical Engineering, or other life science discipline is highly preferred.
• 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.

Benefits

• Reasonable accommodation for individuals with disabilities during the job application or interview process.
• Support for the whole health of employees throughout their wellness, career, and life journey.