Regulatory Labeling Manager (Labeling/Regulatory/Strategy)

Gaithersburg  ‐ Onsite
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Keywords

Description

I have a 12 month Global Labeling Manager contract position for a pharmaceutical client based in Gaithersburg.

The Global Labeling Manager will be required to:

- provide regulatory labeling expertise to cross-functional teams

- assist in the development/production of defined global labeling documents for products.

- support the daily activities of the Global Labeling Director and Global Labeling Associate Director.

Accountabilities:

*Ensure the integrity of labeling processes is maintained.

*Contribute to development of global labeling strategies for assigned products. *Provide labeling expertise to product labeling teams regarding language, placement and regulatory content detail for regional prescribing information and CDSs.

*Lead or contribute to the development of target labeling documents, under Director or Associate Director supervision.

*Prepare and maintain core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet.

*Contribute to or lead cross functional teams in preparation and maintenance of EU and US and related texts while ensuring consistency with applicable core labelling documents and internal standards and SOPs.

If you are interested, please attach an up to date CV and I will be in touch.

To find out more about Real please visit www.realstaffing.com
Start date
03/2014
From
Real Staffing
Published at
08.03.2014
Project ID:
676255
Contract type
Freelance
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