These job descriptions are examples. Looking for work?

Find JobsFind Jobs

FDA Binders Submissions Account Manager

0 people like this description

If you thrive on bringing order to chaos, we have an exciting opportunity to make a big impact with our pharmaceutical client in North Wales, PA. In this role, you will support a highly successful oncology drug that is showing promise in treating many forms of cancer and is being approved for new indications frequently. Each new indication is a new opportunity, and as the Account Manager you will assist in overseeing the timeline and process of compiling binder submissions for promotional materials to the FDA for approval. In addition to the main responsibilities, you may also be responsible for editorial/QA support with the binders content, as well as some very limited hands-on binders creation responsibilities. 

The Project Manager will be embedded with the oncology team on site at the client’s offices near North Wales, PA. 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 opportunity that will last a few months, and 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 if needed, to catch errors on content 
Assist with final binder assembly if needed, on a very limited basis, including making adjustments before final printing to adhere to FDA binder submissions guidelines (i.e. page size, margins, annotations, page numbers). ​


Skills and experience required: 
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. 
Ability to manage multiple priorities in a fast-paced environment 
Strong skills in Acrobat XI and Word 

Please apply online. If you experience technical difficulties, you may email: akijanka [@] aquent.com

These job descriptions are examples. Looking for work?

Find JobsFind Jobs