FDA Binders Submissions Project Manager

North Wales
Job Terms:
Start date:
posted by:
Elizabeth Bennett

Job 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 Submissions Project Manager, you will assist in overseeing the timeline, client relationships, and process around compiling binder submissions of promotional materials for review by the FDA for approval. This role is heavy in hands-on binder production, but is also client-facing with an account management component. 

The Submissions 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 occasional evening or weekend hours when binder submissions are due. This is an excellent temp-to-perm opportunity. 

Specific responsibilities include: 

  • Assist in tracking what materials have been approved and where materials are in the review process
  • Coordinate with agencies to receive PDFs of multiple tactics per submission 
  • Assist with final binder assembly, including making all necessary adjustments to documents before final printing, to adhere to FDA binder submissions guidelines.
  • Interface with job owners and creative agencies to gather information needed for submissions
  • Participate in agency and launch meetings
  • Open and close jobs within project management software
  • QA and proofread documents for submissions
  • Adjustment/Tiling of PDFs to prep for binder
  • Billing and Inventory


Skills and experience needed to succeed: 

  • Professional experience in pharmaceutical industry preferred, but a degree in marketing and/or the sciences in addition to other qualifying skills/experience, will be considered in its place
  • Experience with FDA submissions process preferred
  • Excellent organizational skills and attention to detail
  • Exceptional communication skills and experience managing key client/customer relationships 
  • Ability to manage multiple priorities in a fast-paced environment 
  • Strong skills in Acrobat XI and Word
  • Project Management experience


Client Description:

Aquent Studios provides custom-tailored consulting and outsourcing solutions. Our team of consultants, project managers, and creative professionals brings decades of experience to help our clients expand their capacity in marketing communications, content development, and creative media. Aquent Studios is a division of Aquent, which is the world’s largest marketing staffing firm. Aquent is privately held and headquartered in Boston, Massachusetts. www.aquentstudios.com