Submissions Specialist

Responsibility

• Become the expert on system requirements
• Be the primary point of contact for all submission needs and guidance
• Become the internal gatekeeper/QA for submission packages
• Attend initial/ongoing training updates on submission platform requirements
• Review job starter form, and project brief for accuracy
• Review mandatory items, PI, ISI, to ensure they are represented correctly
• Confirm file formats, naming conventions per guidelines
• Confirm all support materials are included, i.e., references, layout indicators, functional annotations
• Review tagging and linking of references in system to ensure accuracy
• Develop knowledge of reference library and expiration dates
• Collaborate with team to solve problems and resolve questions regarding submissions
• Continuously look to improve the process standards to ensure quality
• Partner with account team to compile a list of brand standard/global mandatories
• Maintain a submission calendar for brand team
• Understand OPDP submission requirements and complete QC checks
• Manage multiple submissions and deadlines
• Maintain accurate documentation
• Provide guidance to junior submission specialist as needed
  

Requirements

• 5+- years’ experience in pharma advertising with knowledge of regulatory review process. Strong planning and organization skills with extraordinary attention to detail.
• Excellent verbal and written communication skills and a basic comprehension of scientific content.
• Background in account management/project management ideal, but candidates with copy or editorial background could also be trained.
• Proficient with MLR Submission Platforms, Microsoft Office and Adobe Acrobat.
• Efficient, self- starter, quick study, flexible. Bachelor’s Degree or equivalent experience required.