Medical Information Specialist (Contractor) - United States
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- 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.