Associate Director, Global Regulatory Labeling

• 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.

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

Connect with us on - LinkedIn | Facebook | Twitter