Submission Specialist

Prose on Pixels


Date: 10 hours ago
City: Chennai, Tamil Nadu
Contract type: Full time
Works closely with project management, account, editorial, copy and junior submission specialists, to ensure all components of submission meet platform requirements.

  • 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.

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