Sr. Technical Writer

Johnson & Johnson MedTech; Durban; Remote; ZAR 1,216,000 - 1,564,000; Full time

Job summary

A leading medical technology firm is seeking a Sr. Technical Writer to oversee Clinical Evaluation Reports and mentor junior staff. This remotely available position requires expertise in medical device regulations and a strong background in clinical research. The candidate must have at least 4 years of experience in the medical device industry and excellent communication skills. Join a team dedicated to innovating surgical solutions and improving patient outcomes.

Benefits

Medical insurance

401(k) retirement plan

Long-term incentive program

Generous vacation policy

Qualifications

• Minimum of 4 years of related job experience required.
• Experience in document creation and evidence generation in clinical settings.

Responsibilities

• Plan and write Clinical Evaluation Reports and Summary of Safety and Clinical Performance Reports.
• Mentor junior writers and ensure document accuracy.
• Participate in workshops to improve process efficiency.

Skills

Medical device industry experience

Strong verbal communication skills

Knowledge of clinical evaluation regulatory requirements

Interpersonal relationships

Proven knowledge in clinical research

Education

BA, BS, or BSN

Advanced degree

Job description

Overview

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; Massachusetts (Any City); New Jersey (Any City); New York, New York, United States; Pennsylvania (Any City); Texas (Any City)

Job Description

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

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

This is a remote role available in multiple states/cities. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply.

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting!

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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 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.