Labelling Coordinator- MEWA Job

Job description

Labelling Coordinator
- MEWA-000011BDDescriptionJohnson & JohnsonCaring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. 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. We have more than 275 operating companies in more than 60 countries employing nearly 128, 000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.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 Middle east covers 3 sectors: Consumer, Medical Devices and Diagnostics and Pharma. Generally covers Middle East, North Africa & Pakistan region, 37 countries; 300 employees across MENAP, with 37 Nationalities.
Role Description:
- Preparation, review, follow-up, implementation and coordination of new or modified labels text for MEWA region.
- Liaison with internal departments and external suppliers to maintain labeling compliance on market.
Key Responsibilities:
- Update current labels to comply with the latest approved product information.
- Coordinate new products/packs artworks development.
- Generate final label approval from Regulatory, Medical, Marketing and Quality.
- Manage and coordinate local language translations of PIL/labels.
- 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.
- Manage, track and maintain approved labeling materials archives and database.
- 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.
- Identify labeling issues (as errors, inconsistencies and conflicts) between package leaflet and SmPC and take the lead to solve such issues.
- Report Adverse Event & product quality complaints as per J&J Pharmacovigilance guidelines.
- Comply with local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).QualificationsRole Requirements:
- Bachelor degree in any related discipline.
- At least two years of experience in labeling or related Regulatory Affairs activities in pharmaceutical industry.
- Must be detail-oriented, self-motivated, highly organized and have the ability to prioritize work.
- Anticipation and planning skills.
- Fluent English and Arabic.
- Comfortable with IT systems and PC minded (Office, Adobe Acrobat and ability to handle databases).Primary Location:Europe/Middle East/Africa-Egypt-CairoOrganization: Janssen Egypt (7804)Job Function: Regulatory Compliance