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FDA Binders Submissions Account Manager

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If you thrive on bringing order to chaos, we have an exciting opportunity for you to make a big impact with our pharmaceutical client in North Wales, PA. In this role, you will assist in overseeing the timeline and process of compiling binder submissions for promotional materials relating to one of our client's drugs, to the FDA for approval. You may also be tasked with some limited editorial/QA support for the binders content, as well as some limited binders compilation responsibilities. 

The Account Manager will be embedded with our team on-site at the client’s offices near North Wales, PA. It will be a very client-facing role. The nature of this work involves extended hours or weekends when binder submissions are due (only about 20% of the time). 

This is a contract role lasting a few months, potentially longer. 

Responsibilities: 
Assist in tracking what materials have been approved and where materials are in the review process 
Coordinate with agencies to receive pdf’s of multiple submissions per tactic and compile into binders 
Adhere to FDA binder regulations 
Provide editorial and QA assistance to catch errors on content, if needed
Assist with final binder creation, if needed, making all necessary adjustments before final printing to adhere to FDA binder submissions guidelines (i.e. page size, margins, annotations, page numbers). 

Skills and experience: 
Experience with project management of content or creative projects, preferably in a regulated environment 
Experience with editorial support in the form of copy editing, proofreading, writing, etc. (preferred)
Ability to manage multiple priorities in a fast-paced environment 
Strong skills in Acrobat XI and Word 

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