Sr. Technical Writer

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

Job Function:

R&D Operations

Job Sub Function:

Clinical/Medical Operations

Job Category:

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for a Sr. Technical Writer to join our MedTech Surgery business.

The Sr. Technical Writer provides oversight and execution of Clinical Evaluation Reports/Plans (CER) and Summary of Safety and Clinical Performance Reports (SSCP) for Ethicon Endo-Surgery within J&J Global R&D Medical Device sector.

DUTIES & RESPONSIBILITIES

Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will be responsible for:

• Planning and writing CEPs, CERs (including State of the Art protocols and reviews) and SSCPs
• Mentoring junior writers.
• Conducting technical reviews to ensure document accuracy and compliance to local procedures, J&J guidelines and regulatory requirements.
• Partnering with cross-functional team members to address needs of each contributor.
• Leading daily activities to ensure timelines are met.
• Participating in workshops and other initiatives to help define and continuously improve process efficiency.
• Participating in continuing 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.
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs additional assigned duties as needed.

EXPERIENCE AND EDUCATION

• BA, BS, or BSN is required; advanced degree is preferred
• Minimum of 4 years of related job experience is required

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Experience within the medical device industry and knowledge of global clinical evaluation regulatory requirements, document creation, and associated evidence generation
• Strong verbal communication skills and interpersonal relationships
• Proven knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred

Benefits Summary:

• 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)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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
  • 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

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$105,000 - $169,050 (Bay Area: $121,000 - $194,350)

Additional Description for Pay Transparency:

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.