Pharmaceutical Labeling Specialist - Remote

:

• Notifies appropriate groups or changes or recent source/reference labeling approvals.
• 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.
• Works under the guidance of the International Labeling Operations Lead or with Senior Specialists
• 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.
• 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.
• Prepares country-specific labeling in support of safe and appropriate use of products for in-scope countries; maintains country specific translation mastercopy to meet labeling responsibilities.
• Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives 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.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.
• Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.

Requirements

• Good communication and organizational skills and a meticulous eye for details
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)
• 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.
• Good understanding of pharmaceutical or medical terminology
• Experience working on multi-disciplinary teams and projects
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications
• Bachelor’s degree; OR
• US military experience will be considered towards industry experience requirements.
• Basic knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU
• Must possess an excellent command of language (English) and professional knowledge of medical terms,
• 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)