At some point in your pharmaceutical/medical device career, you will likely be part of a company at the receiving end of an agency warning letter. How you respond will determine whether your company survives. Here are a few pointers from the trenches of a warning letter response:

• Embrace the suck – the situation is bad but deal with it. Massive confusion at the senior level does not lead to the employee confidence and engagement you will need to be successful.
• Acknowledge how you got to where you are – no one did this to you; you did it to yourselves. Similarly, only you can get yourself out. You are not trying to place blame, but part of your assessment should include a postmortem on the broken process.
• Get some help – there are plenty of consultants available on relatively short notice. You should consider developing a few relationships in advance of need.
• Give permission for honest exchange – change must occur for successful recovery, and this will make many uncomfortable. Be transparent about the process, encourage employees to ask questions, and include diverse perspectives on your change teams.
• Be pragmatic – sometimes the best answer will be very painful, including layoffs, shutdowns, reorganizations. These difficult decisions don’t improve with time, so make them, communicate them honestly, and get past the pain.

See also my previous post on responding to agency observations for additional ideas.

Text Copyright © 2018 Katrina Rogers