Apart from the well-documented issues of heartbreak and overconsumption of alcohol, nothing gives a RegOps professsional the year-end blues like scrambing to finish a submission the last week of December. Here are some suggestions for how to avoid the blues this year. (Sorry, you’ll have to work out the heartbreak and alcohol issues elsewhere.)
Tag Archive: Project Management
Avoiding the Year-End Blues
eCTD Submission Project Management
Managing eCTD submission projects involves balancing a complex set of conflicting requirements. The role of Submission Project Manager is often vaguely defined and ends up defaulting to someone in Regulatory Operations, who may be more skilled as a publisher than project manager. While every project is different, there are key elements that will be part of every submission project. The right approach can minimize stress by outlining the process and identifying the key handoff points between functions.