December and RegOps

This is my favorite time of year, I admit it. I love Christmas and the holidays, garlands and lights on everything, sugary snacks and liquor abounding.

But being in submission publishing always made it a little tough to fully enjoy the buildup because there are always those end of year submissions. They are in addition to the end of quarter, end of month, end of week, end of day submissions of course. But end of year was all of those rolled into one; so you can’t really relax until that last submission is out the door. THEN your holidays start.

One year I was working on an electronic IND that was to be submitted on December 18^th. The protocol (including list of references!) was not finalized until the day before. I remember just sitting at my desk, with my little Christmas tree, and Christmas music streaming on my computer, pounding away at finishing up that IND. I’m grateful for that streaming Christmas music, I know it’s a waste of bandwidth, but it cheered me and kept me going. Also cheering were the gifts of vodka from my CMC co-workers, who felt guilty for their lateness as well. Not that we had liquor at the workplace, of course. Because that would be wrong.

It’s been a couple years now that I haven’t actually been in the midst of end of year submissions – either on the periphery “managing”, or just not involved. And because of that, I get to take loads of vacation days at the end of the year. I can’t even begin to explain my guilt at this!! I can’t shake it though. I feel like I am some jerky person lolling around when I know, I KNOW somewhere someone is working on a submission for December 23^rd or 31^st and I should be helping them.

I even still have a hard time with end of day and end of week meetings. There’s nothing more annoying than getting some meeting scheduled when you have 3 submissions to go out that day and you’re told your presence is mandatory. So for years, I made sure that when I scheduled meetings that involved RegOps people, it was morning or early afternoon, and certainly not on a Friday. Of course, I don’t need to worry about this in my current position, and yet I still get annoyed at late day and end-of-week meetings. Okay, not annoyed, but you know what I mean, my first knee-jerk reaction is hey, I’m going to need that time….oh wait, no I don’t. I wonder if I’ll ever get past that, or if it’s so ingrained after decades, it’s not going anywhere.

I wonder if as we advance even more with the electronic publishing, will all this go away? Will the end-of-whatever rushes go away? Probably not, we’ll still have Reg Affairs folks who try to cram-in last minute submissions. You know who you are! 

So, to all my former and current RegOps co-workers, my holiday wish for you is timely and accurate submissions. Whatever holidays you celebrate, I hope they are happy!!!