Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
Write Investigator brochures and sections of protocols
Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
Act as a writing coach
Coordinate activities related to various types of report writing across a team of writers if applicable
Liaise with client and act as a primary point of contact for all report writing activities
Perform various support activities such as tracking, maintenance of metrics, quality checks and training
Assist in estimation of resource requirement and responding to RFPs as needed
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