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Medical Information Specialist (Contractor) - United States  

Company managed [?] Still accepting applications

Posted on : 29 May 2017

Project Description


Description

 Roles and Responsibilities: 
  • Work with Director of Med info to managing the creation of standard response letters through different stages:
  • Work with Med info Director and outside vendors agency to decide on content of the letters
  • Determine timeline for completion taking timing of medical regulatory and legal  (MeRL) approval meetings into account
  • Ensure agencies have necessary information to complete the letters on time and monitor deadlines.  Field any data requests from agencies as possible.  Monitor spend against budget.
  • Discuss letters on status calls with the agencies and answer any questions/resolve any issues.
  • Coordinate reviews, track deadlines, and promptly follow up with scientific reviewers.
  • Coordinate with MeRL Coordinator to ensure letters are submitted on time and are placed on the agenda.
  • Cross functional project management experience.