Submissions Project Manager

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

Job Description:

Note: This is a short-term engagement (a few weeks) which may turn into a long-term engagement.

If you have an eye for editorial detail, pharma experience, and have managed projects through to completion, 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 and process of compiling binder submissions for promotional materials to the FDA for approval. In addition to the main responsibilities, you will also be responsible for editorial/QA support with the binders content. 

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 extended hours or weekends when binder submissions are due (only about 20% of the time). 

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 to catch errors on content 
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: 
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