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Project 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 Project Manager you will assist in overseeing the timeline and process of compiling binder submissions for promotional materials to the FDA for approval.

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).

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
  • Assist with final binder assembly including 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 required:
  • 5+ years of experience in pharmaceutical project management (or other highly regulated environment), preferably with direct launch experience
  • excellent organizational skills and attention to detail
  • exceptional communication skills and experience managing agency and client relationships
  • 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, please email: akijanka [@] aquent.com

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