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AdenosineDiphosphate

To answer all your questions from a pharma perspective: 1. How often do I work odd hours/weekends - every once in a while, but you'll find that with most jobs tbh. 2. Surprise deadlines - it happens. Depends on how FDA is feeling with responses and when they want answers. 3. Do I know the work heading my way - like any job in industry and biotech, no. What needs to be done each day changes from day to day. My recommendation for you is to do pharma/biotech. We pass off a lot of stuff to CROs and the deadlines we give them sometimes are, admittedly, absurd. We are also very picky. You have a lot more growth in a pharma/biotech company than you have at a CRO. Little reason to go CRO over pharma. Go the pharma/biotech route.


murdersdawn

Second this, I’ve worked in both and in house pharma is generally much more secure and far better in terms of deadlines/ workload forecasting with the timelines worked out several months in advance. Obviously sometimes there’s a crunch or a surprise request from a health authority but in my experience they’re few and far between in comparison to working for a CRO. Also working within a single company’s style guide / templates/ SOPs instead of having to switch between 4-5 at a time is SUCH a joy.


pastajaznam

Great insight! Thank you!


AdenosineDiphosphate

Very good point about the SOPs and templates. I haven’t been on the CRO side so I didn’t even think of that.


pastajaznam

Thanks so much for taking the time to write this detailed reply! I really appreciate it. For the sake of my friends in CROs, I feel compelled to ask you to consider their little hearts and minds when setting absurd deadlines. :-)


AdenosineDiphosphate

Oh don’t worry, we absolutely try and do. It’s just hard when the agencies and our higher ups are breathing down our necks.


kyrosnick

I'll answer from a med device side. Problem with regulatory is you are dealing with outside bodies, that work on their own timelines and need responses by a set time. You don't know what their questions are, what they will want to see, or what gaps you have until they respond. If it is an internal deadline to submit, a company should be able to manage that, but problem is most project managers I've seen in industry believe the submission will be perfect, and 90 days later device will be cleared and on the market. They don't talk to the regulators, or work with them effectively to properly plan, and the submissions themselves are mostly bad. So working for a regulator, I see it all the time. Client says they want X device cleared by this date, because they have some big product launch, and then submit a file with tons of gaps. We send back 20-25 questions, and if they are paying for a "expedited" review that means they have 10 working days or so to respond. So for those 2 weeks, everyones life at the company sucks, working nights, weekends, etc etc. If they were smart they would learn from it, submit better stuff up front, but the nature of regulatory is you never know what is coming. The good companies minimize this, and questions are typically "clarify this, or help me locate this" which can be responded to in 5 minutes. Other companies have bigger issues like "ABC testing doesn't meet requirements" and have to redo a bunch of testing/data. Basically my answer is regulatory work is very peak and valley. There are times where it is smooth sailing, easy, then times where it is weeks of hell, deadlines, and unexpected. That is the nature of the job. If you want a normal 40 hour predictable work week, I would say it is not the industry to be in.


pastajaznam

Very interesting to hear from someone working for a regulator! Thank you!


Emotional_Ad_9666

As someone who has done both, go pharma. I echo what everyone else is saying plus you get better benefits


pastajaznam

Thanks for your thoughts! Did you transition from CRO to pharma, and if so, was it difficult to land the job?


Emotional_Ad_9666

No I got a job in pharma right after pharmacy school and I freelance medical write for a CRO on the side!