IFU Coordinator

  • 8580-Johnson & Johnson Taiwan Ltd. Legal Entity
  • Raynham, Massachusetts, United States of America
  • 5mo ago
  • Full-Time
  • Hybrid

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 Function:

Supply Chain Engineering

Job Sub Function:

Packaging Design Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

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.

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

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

We are searching for the best talent for an IFU Coordinator to be in Raynham, MA.

Job Summary

Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.

Responsibilities

  • Partners with Project Leads to ensure appropriate labeling requirements are provided

  • Creates and maintains label records

  • Creates and inspects label templates

  • Coordinates Instruction for Use (IFU) - translation, graphic design, layout and printing

  • Ensures project commitments are met in terms of delivery dates and budget

  • Proofreads labels and IFUs

  • Ensures labeling meets requirements from procedures, regulations & standards, packaging and other business needs

  • Collaborate with appropriate resources to initiate, manage, and complete all PLM system change requests.

  • Seeks opportunities to improve labeling process in terms of quality, service and cost

  • Responsible for communicating business related issues or opportunities to next management level

  • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

  • 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

Qualifications

  • 3+ years of work experience

  • BS/BA degree or equivalent work experience

Strategic Planning and Scheduling Skills

  • Basic understanding of project schedules

  • Basic understanding of IFU production process regarding timelines

Systems and Standards Knowledge and Skills

  • Basic understanding of PLM systems

  • Basic understanding of printing processes

  • Basic knowledge of translation processes

  • Basic proofreading skills

  • Basic knowledge of symbology and CE marking

Organizational and Problem-Solving Skills

  • Basic organizational and problem-solving skills

Leadership Skills

  • Basic understanding of customer needs

  • Actively participates in Credo, and Diversity and Inclusion

  • Basic understanding of Standards of Leadership

Project Management Skills

  • Knowledge of IFU development process and lead times

  • Basic project management skills

Manufacturing and Supply Chain Knowledge

  • Basic knowledge of manufacturing/supply chain process

  • Basic knowledge of external partners’ requirements

Communications Skills

  • Demonstrates effective writing and speaking skills

  • Demonstrates effective listening skills

  • Demonstrates the ability to work in a team environment

Personal Skills

  • Demonstrates the ability to work independently

  • Ability to work in a team environment

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.

#LI-Onsite 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Brand Research, Controls Compliance, Detail-Oriented, Execution Focus, Good Manufacturing Practices (GMP), Industrial Hygiene, Lean Supply Chain Management, Package and Labeling Regulations, Process Control, Product Packaging Design, Project Scheduling, Proof Reading Software, Quality Assurance (QA), Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Technologically Savvy

 

 

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $65,000 to $104,000 annually.

Additional Description for Pay Transparency:

· 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: o Vacation – up to 120 hours per calendar year o 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 o 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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.