Senior Technical Writer - 2406197252W

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/.

DePuy Synthes is recruiting for a Senior Technical Writer based in the United States. Candidate can work remotely.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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.

Key Responsibilities:

• Planning and writing CERs and SSCPs and mentoring junior technical writers.

• Conducting technical reviews to ensure document accuracy and compliance to local procedures, J&J guidelines and regulatory requirements.

• Partnering with team members to address needs of each contributor.

• Managing daily activities to ensure timelines are met.

• Participating in workshops and other initiatives to help define and continuously improve process efficiency.

• Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.

• Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports.

Qualifications

• 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

Preferred:

• 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

This job posting is anticipated to close on 7/17/2024. 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 pay range for this position is 104000 to 166750.

California Bay Area - The anticipated base pay range for this position is 119000 to 191820.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• 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)).

• 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 of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Primary Location NA-US-Pennsylvania-West Chester

Other Locations NA-United States, NA-US-California

Organization Medical Device Business Services, Inc (6029)

Job Function Clinical/Medical Operations

Req ID: 2406197252W