Pay range:$45 -$50/Hr
Job Description: Role is 100% remote
International Labeling Specialist
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 Client products for in-scope countries; maintains country specific translation mastercopy 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, and additional software or process tools to maintain change history for all labeling documents.
• 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 and 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 results in a product recall due to labeling.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.
Degree Requirements
• Bachelor’s degree – or Master’s Degree, preferred in sciences with 2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.
Experience Requirements
• Must possess an excellent command of language (English) and professional knowledge of medical terms,
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; 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)
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
• US military experience will be considered towards industry experience requirements.
Key Competency Requirements
• Good communication and 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)
