Senior Technical Writer

Johnson & Johnson - Springfield, IL

Full-time - Mid Level

Remote - Springfield, IL

Chemical Manufacturing

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. DePuy Synthes is recruiting for a Senior Technical Writer based in the United States, with the option to work remotely. This role is responsible for providing oversight and execution of EU Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) Reports within the Synthes GmbH Trauma, Craniomaxillofacial (CMF), and Biomaterials businesses. The Senior Technical Writer will be involved in planning and writing CERs and SSCPs while mentoring junior technical writers. The position requires conducting technical reviews to ensure document accuracy and compliance with local procedures, J&J guidelines, and regulatory requirements. The writer will partner with team members to address the needs of each contributor and manage daily activities to ensure timelines are met. Participation in workshops and other initiatives to help define and continuously improve process efficiency is also expected. 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

• Planning and writing Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) Reports.
• Mentoring junior technical writers.
• Conducting technical reviews to ensure document accuracy and compliance with local procedures, J&J guidelines, and regulatory requirements.
• Partnering with team members to address the needs of each contributor.
• Managing daily activities to ensure timelines are met.
• Participating in workshops and initiatives to improve process efficiency.
• Engaging in continuous education activities to enhance understanding of regulatory requirements and industry trends.
• Supporting and acting as a subject matter authority during audits and inspections.

Requirements

• BA, BS, or BSN degree with 5 years of related experience is required.
• Advanced degree is preferred.
• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation.
• Strong verbal communication skills and interpersonal relationships.

Nice-to-haves

• Demonstrated knowledge and experience in quality regulatory compliance, adverse event reporting, medical device risk management processes, and common statistical methods.
• Regulatory/Notified Body audit experience.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees in Washington - up to 56 hours per calendar year
• Holiday pay - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year