Labeling Proofreader/Delivery Manager-REMOTE

Durham, NC 27517

Posted: 02/18/2019 Industry: Other Area(s) Job Number: 33839

Labeling Proofreader/Delivery Manager- REMOTE

The Global Labeling Delivery Manager is responsible for the regulatory role in support of EU and US labeling submissions including managing the EU linguistic review process and authoring content of labeling for US SPL submissions for assigned marketed and/or pipeline products. This individual is responsible for delivering high-quality, submission-ready documents according to required timelines. The Proofreader is responsible for proofing US/EU labeling documents and artwork.

Responsibilities:

Ensure all documents meet health authority technical requirements (US SRPI, EU Conventions and artwork technical requirements)

Ensure submission documents meet in-house authoring standards and are properly formatted Copy editing if requested.

Mark up documents with proofing comments and provide feedback to the requestor Coordinate/communicate with Global Labeling Strategist and Submission/Lifecycle colleagues to complete proofing according to requested timelines

Utilize TVT proofing tool

Ability to prioritize and manage rush proofing working overtime if necessary.

 

Minimum requirements:

•             University Degree in Science or related discipline

•             2 to 4 years of pharmaceutical experience, preferably regulatory experience, preferably working with labeling

•             Knowledge of labeling regulations and guidance

•             Keen attention to detail and accuracy

•             Excellent verbal and written communication skills

•             Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.

•             Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

-  Must be based in the US and have the ability to support EST
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