Teamwork and the Ticking Clock

I am pleased to introduce to you, one of our favorite MLC, LLC team members (well, aren’t they all favorites!?!), Alisia Collett! She’s spent nearly 11 years in the biotech/ pharmaceutical industry and worked her way up from Animal Care Technician to Senior Research Associate. She always seemed to be the person on her team who would end up writing SOPs, protocols, and reports, so it was only natural that she would eventually find her way to her current position of Scientific Editor for McCormick LifeScience Consultants, LLC.

It’s your turn Alisia!!

If you’ve ever worked on a regulatory submission before, you know what a massive undertaking it is to pull together a document that requires so many pieces of information from so many sources. We are talking about literally thousands of pages that need to be pieced together in a matter of months, often while some of the studies being documented are still ongoing. That seems to be enough pressure as it is, but then you remember:  this is a document that may literally make or break your company. This is the document that regulatory agencies will review to determine if the drug that has been years in the making will move forward to the market. And yet, as the deadline looms nearer and nearer, it seems the work will never be done. So, how does all of this come together on time?

You can create a timeline, delegate tasks, and then sit back and expect people to work within that timeline, but the reality of assembling a regulatory submission is that things are always changing, and you and those working with you need to be prepared to deal with those changes. Therefore, the key to success is having a solid, communicative team.

A solid team starts with a great leader, someone who won’t crack under pressure, who can break out a massive undertaking into a series of smaller tasks and give clear guidance regarding what needs to be done, whom needs to do it, and by when each task needs to be completed. At the same time, a leader needs to be realistic and ready to alter timelines as needed to achieve the final goal. However, a leader alone does not make a team.

A great team is comprised of individuals who know what they need to do and how to do it, but are also flexible, and can slide from one roll to another when required. A team is also comprised of great communicators, people who can easily clear up any confusion that may arise. Additionally, a team is comprised of great attitudes; a team needs people who can cheer each other on, even when things get tough. And, let’s face it . . . a team requires people who will work hard, no matter what, with EVERYONE doing their part. Even with a great team, meeting a deadline might require long days, late nights, and work on the weekends. A great team will be comprised of people willing to put in that extra time and do it with a smile.

The success of any project relies solely on the people who work on it. Sometimes, you look at a deadline and the amount of work that needs to be done, and you think, “This is impossible.” The truth is, without the right people working on a project, it may very well turn out that way. Pick the right people for your team though, and you won’t even hear the noise of that ticking clock over the sound of progress being made every day.

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  • Any large undertaking requires assembling a solid team.
  • Look for the following qualities in your team members:
    • Knowledge
    • Willingness to work hard
    • Communication skills
    • Positive attitude
  • Flexibility is key, for both the leader and all members of the team. Timelines and priorities are going to change every day, and you must be capable of rolling with those changes as they arise, while keeping the submission date (which is the only thing unlikely to change!) in focus.