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CAR-T Document Specialist Technical Writer

AT Johnson & Johnson
Johnson & Johnson

CAR-T Document Specialist Technical Writer

Raritan, NJ

Johnson & Johnson is recruiting for a CAR-T Warehouse Document Specialist/Technical Writer! This onsite position is in Raritan, New Jersey!

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/.

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.

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Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

The CAR -T Warehouse Document Specialist/Technical Writer will primarily build, update, and maintain technical documents and communications related to warehouse processes, as needed. Their writing will adhere to set standards regarding order, clarity, conciseness, style, and terminology. Special projects may require this individual to gather and prioritize data from various departments and implement this research into their own work.

Key Responsibilities:

  • Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use, and intuitive
  • Ensure quick turnaround time of document updates to prevent disruption in operations
  • Stay current on industry standards and ensure that all GMP documents incorporate the latest regulatory and quality requirements
  • Supervise the revision process of existing SOPs in-time to support manufacturing strategies
  • Ensure that accurate training is prescribed as per document changes made
  • Assure regulatory compliance and technical feasibility of proposed document changes
  • Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA)


Qualifications

Education:

  • A minimum Associates degree, Vocational, Certificate, Technical required; Bachelor's degree, preferred

Experience and Skills:

Required:

  • A minimum 4 years of professional relevant business experience
  • Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations
  • Ability to learn and operate various enterprise systems including eLIMS, TrackWise, SAP
  • Excellent written and oral communication skills

Preferred:

  • Experience in writing documentation and procedure manuals for various audiences
  • Superb written communication skills, with a keen eye for detail
  • Previous experience in software development and technical writing
  • Standard knowledge of technical applications such as: computers, documentation requirements, regulations, analysis, etc;

Other:

  • May require up to 10% domestic travel to other sites/locations

The anticipated base pay range for this position is $61,000- $91,750 USD.

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

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.

Client-provided location(s): Raritan, NJ 08869, USA
Job ID: Johnson&Johnson-2406211524W
Employment Type: Other