FDA Pre - Submissions Project Manager

North Wales, PA
Job Terms:
Start date:
Posted By:
Agata Kijanka

Job Description:

If you have an eye for editorial detail, pharma experience, and have managed projects from inception through to completion, we have an exciting, salaried opportunity to make a big impact with our pharmaceutical client in North Wales, PA. This position will last through September at a minimum; there is potential for this to become a long-term, ongoing engagement. 

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 and process of compiling submission documents for promotional materials being submitted to either the FDA or APLB. In addition to the main responsibilities, you will also be responsible for editorial/QA support of the submission content.

The Submissions Project Manager will be embedded with the oncology team on site at the client’s offices near North Wales, PA. (After the work-from-home direction has been lifted). The nature of this work may involve extended hours or periodic weekends when submissions are due with tight deadlines (only about 10 to 15% of the time).


  • Assist in tracking what materials have been approved and where materials are in the review process.
  • Coordinate with agencies to obtain PDF’s of their submission materials and compile into file folders on the server and Microsoft Teams while adhering to FDA and APLB submission regulations. 
  • Provide editorial and QA assistance to ensure accuracy in content.
  • Assist with final submission preparation including making all necessary adjustments before final submittal to adhere to FDA and APLB submissions guidelines.

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.

Client Description:

Aquent Studios is a global creative studio that delivers scale, speed and efficiency to the world’s most recognized brands.  We create the work that matters the most to them—work that has a real impact on their business. As an Aquent Studio team member, you’ll have the opportunity to engage with the largest and most influential companies in the world, solving design challenges and extending their brands across tactic types and platforms, including digital design, UI/UX, video, motion, content, print design, web development, and more.  If you want to do work that matters in a collaborative setting that values ingenuity and personal growth, you have found the right place!