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.
