Project Manager / Editorial Support - FDA Binders Submissions

North Wales, PA
Job Terms:
posted by:
Agata Kijanka

Job Description:

If you thrive on bringing order to chaos and have an eye for editorial detail, 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. In addition to the main responsibilities, you will also be responsible for editorial/QA support with the binders content. 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
  • 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

Please apply online. If you experience technical difficulties, please email: akijanka [@] aquent.com

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