International Labeling Specialist

We are a recruiting company EasyHiring looking for candidates for the position of International Labeling Specialistin Bloomingdale, FL for our partners.

Position Summary

The International Labeling Specialist will be responsible for providing oversight and project management related to the planning and execution of both submission labeling documents and final approved artwork within in the Labeling department.

The International Labeling Specialist will support the preparation and delivery of accurate, consistent, timely, and compliant labeling documents for submissions to health authorities, and ensure timely and accurate implementation of product labeling for assigned countries.

The International Labeling Specialist will provide key information to assist with the determination in an appropriate and optimal strategy for original and revised labeling text, to drive prompt Health Authority approvals and implementation into the market. The International Labeling specialist will work cross-functionally and globally as required to support the country, region and/or products assigned

Position Responsibilities

• Works under the guidance of the International Labeling Operations Lead or with Senior Specialists.
• Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.
• Notifies appropriate groups or changes or recent source/reference labeling approvals.
• Prepares country-specific labeling in support of safe and appropriate use of BMS products for in-scope countries; maintains country specific translation master-copy to meet labeling responsibilities.
• Prepares, tracks, maintains and reviews required labeling documents (e.g. physician’s label, patient insert, carton, label, blister, tenders) using Text Verification Tools, PRISM / CARA workflow and additional software or process tools to maintain change history for all labeling documents.
• Ensures all labeling supporting documentation and final approved labeling documents (HA approved content and final artwork) match, are status updated, and tracked in the electronic data management system or systems.
• Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
• Notifies the artwork studio team, manufacturing, global planning and supply representatives as needed of upcoming changes to labeling. Provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that result in a product recall due to labeling.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.

Degree / Experience Requirements

• Bachelor's degree required; Master's preferred with at least 3 years of experience in a regulated environment, including 1-2 years of labeling experience. Labeling experience in the pharmaceutical and/or Bristol Myers Squibb experience is highly desired.
• Military experience will be considered towards experience.
• Proficiency in standard office technology, including Microsoft Suite (Outlook, PowerPoint, Excel) Additional applications such as Adobe and SAP are preferred. Willing to learn additional applications as needed
• Experience working on multi-disciplinary teams and projects
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control) is preferred

Other qualifications:

• Basic knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU

Key Competency Requirements

• Good organizational skills and a meticulous eye for details
• Good understanding of pharmaceutical or medical terminology
• The ability to work as part of a team that supports global functions with a high level of professionalism.
• Knowledge / understanding of another language in a region supported (e.g. Spanish, Arabic, Chinese)

Travel: Occasional travel per to other company sites may be required.

Job Type: Full-time

Work Location: On the road