Senior Associate, Regulatory Promotional Operations

Job Description
The Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting materials to the client (both electronically or in hard copy as determined by the clients' specifications), and tracking the progress of each project through the stages of MLR review.
You'll report to the Manager, Regulatory Review or the Director, Regulatory Review.
This is a hybrid role, requiring three days in-office each week. If you are contacted for an interview, your recruiter will discuss specifics with you, inclusive of any necessary reasonable accommodations.
Your Impact:
· Establish a timeline and assign responsibility to the appropriate team members for delivering the components of the submission
· Oversee the creation of the components and ensure they conform to client and Digitas Health guidelines.
· You will maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines;
and you will maintain the department procedure(s) specific to the clients supported.
· Follow up with client liaison promptly to ensure the submission is received on time and meets 100% of client expectations and specifications
· Act as the primary contact between the agency and the clients' MLR Review department, both to get information about submissions requirements and to answer procedural questions that arise during the MLR review process