Labeling Lead

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Parental Leave

Job summary

Johnson & Johnson MedTech in Santa Clara, CA is seeking a Labeling Lead to manage development and lifecycle labeling for our products. You will drive end-to-end label changes, ensure alignment with artwork, and maintain regulatory compliance.

You will collaborate with Regulatory, Clinical, Quality, R&D, and PM Lifecycle teams to deliver accurate labeling across product lines and enable successful product launches.

Qualifications

• Minimum 4 years of relevant work experience; 6 years preferred.
• Demonstrated track record of project management.
• Ability to manage several projects simultaneously.
• Experience with DITA XML and CCMS.
• Strong influence and conflict resolution skills.

Responsibilities

• Label development for NPD and LM projects.
• Create, edit, and maintain high-quality documentation to support products.
• Communicate business issues or opportunities to management.
• Execute Design Control documentation for label development.
• Complete Label Assessments and IFU/artwork tasks.
• Lead labeling strategies with cross-functional teams.
• Collaborate on label strategy with Regulatory, Clinical, Quality, R&D, PM Lifecycle.
• Coordinate project plans with schedules and manage capacity constraints.
• Write, review, and revise technical documents including user manuals and packaging inserts.

Skills

Project Management

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s degree

Tools

DITA XML

CCMS

Job 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 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

Project/Program Management Group

Job Sub Function

Project/Program Management

Job Category

Professional

All Job Posting Locations

Santa Clara, California, United States of America

Job 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/

Auris Health, a member of the Johnson & Johnson family of companies is currently hiring for two Labeling Lead roles, located in Cincinnati, Ohio and Santa Clara, California.

We are seeking a detail-oriented and strategic Labeling Lead to be responsible for the development and management of product labels for both New Product Development (NPD) and Lifecycle Management (LM) projects. This key role leads all aspects of the end-to-end execution of labeling changes, ensuring alignment with artwork, label components, and regulatory compliance. The ideal candidate will support business objectives by driving label content updates that reflect regulatory requirements, supply chain strategies, and company standards, ultimately ensuring accurate and compliant labeling across all product lines.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Learn more at https://www.jnj.com/medtech

At J&J MedTech we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Join our collaborative, rapidly growing teams. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.

Responsibilities

• Responsible for label development for New Product Development (NPD) and Lifecycle Management (LM) projects
• Responsible for creating, editing, and maintaining high-quality documentation to support our products, ensuring compliance with industry standards and regulations.
• Responsible for communicating business related issues or opportunities to next management level
• Accountable for executing Design Control documentation and execution for label development.
• Responsible for completion of the Label Assessment, redline of IFU/artwork, IFU Creation forms and ACCLM content sheet/DCAF, translation management.
• Point person for New Product Development/LifeCycle teams in executing labeling strategies, project plans and executing project plans in support of label development for new product launches and lifecycle revisions.
• Responsible for leading collaboration for collecting requirements, alignment on label strategy and label content with Regulatory, Clinical, Quality, R&D, PM Lifecycle, as required.
• Accountable/responsible for working with labeling execution planning to align label development project plans with the project team schedules, escalating to resolve capacity constraints through prioritization, augmenting capacity or relieving project timing as aligned with project team and business units.
• Write, review, and revise technical documents including user manuals, packaging inserts, service manuals, and training materials.

Qualifications

Education

• Minimum of a Bachelor’s degree and/or University degree is required

Required

• A minimum of 4 years of relevant work experience is required. (6 years is preferred)
• Demonstrated track record of Project Management
• Demonstrated ability to manage several projects simultaneously
• Information development using DITA XML and component content management systems (CCMS).
• Influence and conflict resolution

Preferred

• Demonstrated ability to lead a cross-functional cross region team.
• Demonstrated understanding of Medical Device or equivalent regulated industry, Quality Systems and Change Control procedures.

Other

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

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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Preferred Skills

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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.

Benefits

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