Associate Director, Global Regulatory Labeling

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• Flex position in Global Labeling, for a Global Labeling Product Leader for the Infectious Diseases/Vaccines/Global Public Health Therapeutic Area. The GLPL will have responsibility for: 

• The creation and maintenance of primary and derived labeling documents, and text for artwork for packaging components through the LWG and LC processes, as required 

• Ensuring quality of primary and derived labeling documents, and text for artwork for packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents) 

• Contribution to and implementation of the global labeling strategy including the development of target labeling 

• Principal responsibilities include: 

• The creation and maintenance of primary (Core Company Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)) and derived (International Package Insert, labeling text for EU, US and international package components, and translations) labeling documents. Takes into account competitor labels when drafting labeling text. 

• Coordinates the development, revision, review and approval of primary and derived labeling documents including the Labeling working Group (LWG) and Labeling Committee (LC) activities related to these documents 

• Ensures dissemination of LC-approved CCDS, USPI, EUPI and derived labeling documents and supporting documentation 

• Ensures quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents) 

• Contributes to and implements the global labeling strategy.

Additional Information

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

 Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 

Office: 973.967.3348 | Fax: 973.998.2599

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