Medical Legal Review Specialist

Responsibilities

• Responsible for completing Med Legal Review (MLR) submissions to a variety of Pharma Brand companies.
• Responsible for data collection and entry of all changes communicated from the client for each MLR submission in preparation for reporting to client.
• Create and maintain a data repository that will be used by all internal teams to outline the MLR process and guidelines.
• Attend client specific MLR trainings as needed.
• Work with Account Managers and Project Managers to understand and update requirements as needed.
• Develop MLR submission schedule weekly.
• Distribute MLR submission schedule to Group Account Directors and Project Managers.
• Work with internal teams to execute high-quality submissions in compliance with Pharma medical/legal review process.

Qualifications

• Must be able to handle multiple projects and consistently meet deadlines, working collaboratively with colleagues in editorial, project management and account management.
• The appropriate candidate will have 2+ years of experience in regulatory review of advertising and promotional material in the US pharmaceutical industry. Experience in DDMAC submissions a plus.
• Ability to work efficiently and plan ahead, anticipating issues before they arise.
• Excellent writing and editing skills are required, with attention to detail and ability to work within institutional guidelines.
• Good problem solving skills.
• Ability to work efficiently under tight deadlines and to handle sensitive and confidential information with discretion.