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Pharma Account Manager - FDA Binders Submissions

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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. You will work in a client-facing capacity in this role. 

The Account 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).

Responsibilities:

  • Assist in tracking what materials have been approved and where materials are in the review process
  • Coordinate with external agencies to receive pdf’s of multiple submissions per tactic and compile into binders
  • Interface regularly with client throughout the course of each binder project
  • Adhere to FDA binder regulations
  • Possibly provide some light assistance with final binder assembly 

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.
  • Experience working in a client-facing capacity
  • Ability to manage multiple priorities in a fast-paced environment
  • Strong skills in Acrobat XI and Word
  • Experience with inventory, reporting, and/or billing is highly preferred

 

 

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