The Manager of Electronic Publishing supervises and coordinates the activities of the Medical Writing Electronic Publishing Group. The departmental responsibility includes the preparation of Electronic Publishing, or components of, an eIND, eNDA, eBLA, eCTD, and other worldwide regulatory submissions while providing document life cycle management. This person leads the development and implementation of project-specific processes for sponsors with unique technology requirements and may act as the PPD liaison for regulatory submission with the sponsor.
The Manager also serves a quality review role and as such is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations. These documents include, but are not limited to, regulatory submissions (sections of NDAs, PLAs, INDs), clinical/statistical reports and study protocols.
Education and Experience:
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