Senior 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

The Technical Writer is responsible for driving results in a fast-paced mutli-faceted environment by leading the technical writing of GMP documents and investigations associated within the NJ Stability Lab Operations. Assignments are of varying complexity, where sound judgement and self-drive/initiative are required to resolve problems and make recommendations/decisions. This position requires technical writing and investigations to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)

General:

• Provide project/study and investigation support through review and technical writing of GMP documents (e.g. study specific protocols or validation reports), SOPs and other documents associated within QC area of responsibility.
• Uphold our Credo values including creating a positive work environment.
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying assignable/root causes and determining effective corrective and preventative actions.
• Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization.
• Proofread documents for content and identify non-standard format or wording, and errors within documents.
• Review data where required pertaining to documents being drafted
• Participate in gap assessments of technical documentation to ensure methods are up to current standards, and that processes investigated are present and functioning optimally. Provide recommendations/solutions to remediate any recognized gaps.
• Present authorship strategy to management to get pre-approval and Endorsement.
• Build and maintain a progress-tracking matrix on document generation, qualification execution, document review and approval (Escalate any issue/delay to management as applicable).
• Collect and trend historical data.
• Responsible for preparing technical documentation for highly complex issues (i.e. high impact investigations). • Make contributions to improved processes and templates as it relates to laboratory investigations. • Provide training and mentorship for new investigation writers and lab analysts as it pertains to technical writing

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

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

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits