About this role
About the Role The Senior Associate, Regulatory Operations is a project-level lead responsible for independently preparing promotional materials to be submitted to our pharmaceutical 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. What You'll Do
- 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. What We're Looking For
- Bachelor's degree and 2-4 years of experience in the preparation of complex submission deliverables under tight deadline constraints.
- Technical competency in Adobe.
- Experience preparing promotional materials for Medical, Legal, Regulatory (MLR) review in pharmaceutical/healthcare contexts.