The Account Coordinator works as part of the Pharma Account Management team. This person will follow the protocol established by our pharmaceutical company clients when submitting marketing materials for regulatory review.
At Hill Holliday, we help our clients fight the daily share battle by swinging hard and fighting smart. We stay laser-focused on the most important part of the equation: the idea. Nothing beats a good one. And every day we come to work to think of more of them into existence to help our clients dominate the noisiest of categories.
We also know that work is about more than just, well, work. It’s also about the people . And we find that when we let those people do their thing – their curious, tenacious, scrappy, be-happy thing – what results is innovative thinking that wins.
The Account Coordinator must follow the protocol established by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing editorial content for the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting and tracking the progress of each project through the various stages of MLR review.
- Follow client-mandated procedures for all submissions
- Enforce standards for all Medical/Legal submissions
- Management of core claims and brand references document for all brands (content
- provided by Medical Editors)
- Be familiar with all types of submissions and their requirements
- Be responsible for MLR workflow start to finish, this includes opening job codes, initial project submission, pulling feedback from the reviewers and distributing to Account team, submitting completed editorial content for Approval, pushing digital/electronic pieces through functional review (when applicable), and delivering final samples to DRA for FDA submission
- Participate in client regulatory reviews and coinciding regulatory review status meetings
- Run various types of reports within the MLR based on the Account team’s needs
- Liase internally with Account team to align on schedules, submission dates, etc.
- Liase externally with editorial and MLR lead to align on submission schedules and outstanding queries
- Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex deliverables under tight deadline constraints is required.
- Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required.
- Experience communicating with clients (regulatory team) directly is required.
- Clear communication and attention to detail are essential.
- Experience in Pharmaceutical Industry or Healthcare Regulatory Review Process is strongly preferred.