Labeling Standards Lead

Johnson & Johnson Innovative Medicine • Cincinnati, OH

2d • $94,000 - $151,800 • Onsite

About The Position

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 SUMMARY The Labeling Standards Lead is responsible for successful management of labeling standards and regulations.

Requirements

• Minimum of a Bachelor’s or equivalent University Degree required
• Minimum 4 years relevant work experience
• Experience in the Medical Device industry or medical field
• Verbal and written communication skills
• Project Management experience, with FPX and/or PM Mastery certification
• Working in a matrix environment across geographies and organizations
• Strong analytical and problem-solving skills
• Works effectively and builds relationships across functions and stakeholders
• Strong Organizational and Prioritization skills
• Negotiation and Conflict Resolution Skills
• Knowledge of QMS and Medical Device Regulations
• Personal computer skills, MS Office applications, Word, Excel, PowerPoint, Visio, Teams

Nice To Haves

• Process Excellence Green Belt required, Black Belt in 6-Sigma or Lean
• Change Management experience
• Understanding Regulations and Standards for labeling
• Working knowledge of ERP and PLM systems
• Process Development and improvement
• Demonstrated understanding of an end-to-end Supply Chain
• Ethicon product knowledge

Responsibilities

• Lead identification and understanding of labeling requirements from standards organizations or regulatory bodies.
• Drive consistent interpretation of labeling requirements through cross-functional, cross-franchise, collaboration to meet business needs.
• Maintenance, and continuous improvement of applicable labeling procedures.
• Participates in review of emerging new labeling guidance and guidance changes; ensures consistent implementation via procedure changes, as needed.
• Accountable for leading labeling-owned gap assessments and serve as subject matter expert for non-labeling owned assessments.
• Support internal and external audits; notified body responses and findings related to ISO and Regulations.
• Develop methods to elevate knowledge of ISO/Regulation requirements to achieve a compliant label.
• Provide ownership to CAPAs (Corrective And Preventive Action), Audit Findings and Non-conformances as assigned
• Manage or lead labeling-related improvement projects of moderate size, complexity, and business impact.
• Problem analysis and resolution.
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a 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 ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level