IFU Coordinator

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 were 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 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 & 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 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 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 $65000 to $104000 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 corporations performance over a calendar / performance year. Bonuses are awarded at the Companys 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 Companys 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. 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.

Required Experience :

IC

Key Skills

Corporate Risk Management,Electronics,Infection Control,Bakery,ELV,Accident Investigation

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 65000 - 104000