Senior Associate, Regulatory Operation

Overview
The Senior Associate, Regulatory Operations is a project-level lead who is responsible for independently preparing promotional materials to be submitted to our pharmaceutical company clients’ Medical, Legal, Regulatory (MLR) review in accordance with both client specific standards and requirements as well as internal guidelines. The Senior Associate is responsible for tracking the progress of each project through the various stages of the MLR review process, advising on submission timelines, and following up directly with internal stakeholders as needed.

Responsibilities
Assemble submission packages through taking screenshots, annotating pertinent information, and attaching references and other ancillary documentation.
Ensure components conform to both client and Digitas Health guidelines and requirements.
Determine the time and effort required to create various components of each submission. Work directly with internal teams to develop submission timelines.
Comfortably balance multiple projects simultaneously.
Follow up with internal teams directly to communicate project status and timing expectations.
Skillfully manage client expectations through clear and concise communication.
Assist in maintaining departmental archive.
Qualifications
Required

Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex submission deliverables under tight deadline constraints
Technical competency in Adobe Acrobat and the Microsoft Office Suite
Clear communication and attention to detail
Top notch organizational skills
Clear, concise technical writing ability

Preferred

Experience working on cross-functional teams
Working knowledge of Adobe InDesign and Photoshop

Desirable

Experience in Pharmaceutical Industry, Healthcare, or similar environment
Agency and/or project management experience