Submission Specialist

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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