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Senior Technical Writer - 2406186355W

Description

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. Learn more at https://www.jnj.com/.

Ethicon is recruiting for a Senior Technical Writer based anywhere in the United States.

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. Focus areas include: Surgery, Wound Healing, Hemostasis, Women’s Health, and Hernia Repair

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.

Key Responsibilities:

Main areas of responsibility

• 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.

Qualifications

Bs degree with minimum of 5 years of related experience

Minimum of 3 years related 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.

Preferred:

MS in areas of Engineering, Nursing, Biomedical Engineering or other life science discipline

BA, BS or BSN 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.

This job posting is anticipated to close on 6/13/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base salary for this position is $104,000 to $145,000.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-United States

Organization Medical Device Business Services, Inc (6029)

Job Function Clinical/Medical Operations

Req ID: 2406186355W