Organization

• Timeline management

• Develop and manage content plan

• Clearly define responsibilities / communication plan

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Compilation

• Manage issues from identification through resolution

• Track and manage version control challenges

• Leverage technology where appropriate

• Employ best practices to produce process efficiency

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Publishing 

• Manage content plan against agency requirements

• Analyze and publish submission components and interpret guidance requirements for each

• Apply practical knowledge of validation criteria

• Use enabling technologies to verify compliance and view the final output

• Manage process that is informed by practical experience and driven by best practices

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Dispatch

• Obtain signing certificate for the FDA Electronic
  Submissions Gateway (ESG)

• Submit premarket and postmarket regulatory information for FDA review

• Manage gateway receipts for clients

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Maintenance

• Understand and communicate agency deadlines

• Respond quickly and efficiently to present challenges, opportunities, and options