Labeling coordinator - Fixed term

Job Description

Johnson & Johnson Consumer is recruiting for a Labeling coordinator ? Fixed term to be located in Dubai, UAE. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It?s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, 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 a new entity within New Consumer Health and your employment would be governed by New Consumer Health?s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. Objective Management and implementation of labeling based on global SOPs and local regulation. Liaison with internal departments and external partners to maintain labeling compliance on market. Compliance activities. Revision of regulatory internal procedures, assessment of potential gaps and preparation of standard operation procedures. Duties & Responsibilities Coordinate labeling update submissions with regulatory experts and follow-up on approval Coordinate the creation or the update of local labeling (R4AW) Prioritize safety labeling changes for the MEWA pack to be implemented on timely manner. Support of new product/packs artworks development with regulatory expert. Ensure that changes/new creations are approved and implemented on time to meet HA commitments and internal compliance guidelines while maintaining uninterrupted and optimized supply for operations Coordinate the review and approval from regulatory, medical, and marketing as applicable. Participate in regulatory labelling implementation and supply chain criticality meetings and ensure they are running regularly, and proactive decisions are being made. Controls distribution of correct labels to packaging lines and implementation of correct material in the market Track, follow-up and communicate implementation with support of Supply Chain and Quality Manage, track, and maintain approved labeling materials archives and database. Act as subject matter expert for labeling related activities and procedures and perform regular training as needed Support regional and local team on the deployment of serialization in the region. Update relevant ArtWork on Serialization platforms (i.e Brandsync) Identify labeling issues (as errors, inconsistencies, and conflicts) between package leaflet and SmPC and coordinate with the regulatory expert to solve such issues Assist in revision of regulatory activities to be fully described in global or regional SOPs and in line with the local guidelines. Close potential gaps by preparing local SOPs or WI accordingly. Optimize the use of the company resources while fulfilling the above activities. Relationships Interact with Regulatory Affairs, Supply Chain, Quality Assurance, Global Graphic services, Global Compliance group, Manufacturing sites and local affiliates/distributors Qualifications Experience Required Education: Healthcare related degree. Years of experience: 1-5 years (Regulatory, Labeling) Language: Fluent Arabic and English (French is a plus) Primary location: Dubai Technical/Functional Skills Required Precision and accuracy in task execution Flexibility Strong work ethic. Ability to manage multiple projects at the same time and deliver results within deadlines Critical thinking and ability to challenge the status quo Strong communication skills Microsoft tools proficiency: Excel (+++), Power point and Word Good presentation skills. Strong reporting and analytical skills. Leadership Behaviors Required LIVE OUR CREDO & Pursue our Purpose: Demonstrate and models the heart of Johnson & Johnson CONNECT: inclusively to address health needs SHAPE: the future of health through innovation GROW: self and others to become our best For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we, in United Arab Emirates are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means ?You Belong?! Primary Location United Arab Emirates-Dubai-Dubai- Organization Johnson & Johnson Middle East FZ-LLC (8608) Job Function Regulatory Affairs Requisition ID 2206030143W

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