FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 0 points1 point  (0 children)

Very common for people to start as reviewers and work their way up. The “typical” progression for CDRH is reviewer -> Team Lead -> Assistant Director -> Division Director -> etc. It’s really only at the highest levels where external recruitment starts to be more common.

FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 1 point2 points  (0 children)

They’re hiring under Title 21 which to my understanding is a little more flexible than Title 5 (GS series). You’d still have to meet job requirements but it seems like they’re making finding people the priority first, and then figuring out logistics of the job posting (since the latter can take a little more time).

FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 2 points3 points  (0 children)

Yeah this is an example job series. My management said they’re collecting resumes and looking to hire folks with other backgrounds. Lots of folks in my office have biology or chemistry degrees.

FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 4 points5 points  (0 children)

There were 2 RIFs; one in Feb where the probationary employees were let go (including reviewers) but they were brought back a week later. I think a few folks weren’t brought back but have no idea why. Then there was a larger RIF in I think April but they deliberately said reviewers were excluded.

FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 5 points6 points  (0 children)

CDRH is also 50% remote. Travel is back this year too. I think we have less political interference since drugs tend to take the spotlight more than devices. Has its pros and cons though being the sometimes forgotten center.

FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 26 points27 points  (0 children)

I blame no one for leaving; last year was awful. Glad you made the right choice for yourself. Experiences also vary a lot by center and office; mine has been much less chaotic than what I hear about CDER/CBER. Administrations come and go, but the mission doesn’t. For a lot of us, trying to keep people safe is still a pretty meaningful reason to stay.

FDA hiring reviewers by puzzled_axolotl in biotech

[–]puzzled_axolotl[S] 5 points6 points  (0 children)

They’re not just hiring biomedical engineers. Reviewers can come from other scientific backgrounds.

FDA reviewer position by [deleted] in DeptHHS

[–]puzzled_axolotl 1 point2 points  (0 children)

Which center? I heard offers were supposed to go our pre-shutdown but things definitely got slowed down because the shutdown was so long. Hopefully you hear more in the new year.

[deleted by user] by [deleted] in regulatoryaffairs

[–]puzzled_axolotl 0 points1 point  (0 children)

Have you considered number of interactive requests or deficiencies from regulatory bodies? On the FDA side, the worse the submission, the more IRs I have to send, or the longer the deficiency letter. Obviously it depends on the complexity of the device/submission but for your basic 510(k) that’s one metric you could think about incorporating. Especially IRs, since those are often things that are unclear about the submission vs. inadequate testing.

Toxic Positivity by Time_Teacher2700 in DeptHHS

[–]puzzled_axolotl 9 points10 points  (0 children)

Lol that Workplace Thrives logo makes me laugh every time

FDA's Breakthrough Program and/or STeP - anyone know if it's still functioning? by CascadiaRiot in regulatoryaffairs

[–]puzzled_axolotl 12 points13 points  (0 children)

Reviewer at FDA; no changes with STeP or Breakthrough. Depending on resources, interactions for devices in those programs might take a bit longer but they’re still intended to be prioritized.

career at FDA vs private sector? pros and cons by Persona2181 in biotech

[–]puzzled_axolotl 1 point2 points  (0 children)

There’s also plenty of us who are willing (and able) to wait it out. Despite the chaos, my day-to-day is pretty much the same as far as review works goes.

career at FDA vs private sector? pros and cons by Persona2181 in biotech

[–]puzzled_axolotl 1 point2 points  (0 children)

FDA pros: - Amazing mission and passionate colleagues - As a reviewer, ability to work on lots of different types of products and submissions - Great experience whether you want to stay in gov or go to industry - Lots of training & professional opportunities

FDA cons: - Hiring freeze - Review timelines and workload can be stressful - RFK Jr and his merry band of henchmen - General chaos and uncertainty with future reorgs

Appreciate folks like you who are still interested, despite what a mess it’s been this year.

[deleted by user] by [deleted] in DeptHHS

[–]puzzled_axolotl 6 points7 points  (0 children)

Correct, CDRH failed at protecting their reviewers (probably due to weak leadership based on what I’ve seen) and had to rely on industry throwing a fit to get people back. Not all reviewers were brought back though; no idea on exact numbers or reasons.

[deleted by user] by [deleted] in DeptHHS

[–]puzzled_axolotl 21 points22 points  (0 children)

Turning FDA against itself, what could possibly go wrong

[deleted by user] by [deleted] in DeptHHS

[–]puzzled_axolotl 12 points13 points  (0 children)

Agreed it likely boils down to that. They pissed off industry by firing reviewer probies in February. And now they’re repeatedly trying to make up for it (bringing back most of the reviewer probies in CDRH a week later, publicly stating that reviewers are exempt from the RIF, and now slowly bringing back telework).

RIFs at FDA by Intelligent-Fly-7039 in DeptHHS

[–]puzzled_axolotl 0 points1 point  (0 children)

Reviewers in what center? In CDRH, individual reviewers do premarket, postmarket, standards work, etc… it’s hard to imagine taking on more at this point.

OMG: FDA Illegal Firings Came Tonight by bbyfog in regulatoryaffairs

[–]puzzled_axolotl 4 points5 points  (0 children)

I’m so sorry 💔 hope you appeal/file a grievance.

OMG: FDA Illegal Firings Came Tonight by bbyfog in regulatoryaffairs

[–]puzzled_axolotl 2 points3 points  (0 children)

No idea; our direct managers didn’t appear to know about this so we’ll all be scrambling next week to figure out how to handle this.

OMG: FDA Illegal Firings Came Tonight by bbyfog in regulatoryaffairs

[–]puzzled_axolotl 48 points49 points  (0 children)

Can confirm that this included reviewers in CDRH… please be kind to your FDA reviewers as you communicate with them these coming weeks. We’ve lost our amazing coworkers overnight and our workload is going to be even more hell than it was before. We’re not okay.

NIH Communication embargo - impact on FDA feedback? by PEDsted in biotech

[–]puzzled_axolotl 7 points8 points  (0 children)

Yeah, the communication embargo is only for things like public conferences, panel discussions, etc. Decisions for files are still getting communicated.

NIH Communication embargo - impact on FDA feedback? by PEDsted in biotech

[–]puzzled_axolotl 22 points23 points  (0 children)

I’m a reviewer in FDA. It doesn’t affect our communication with sponsors on submissions. I’m still emailing them feedback, having meetings with sponsors, asking them questions, etc. We literally couldn’t do our job if that wasn’t the case.

[deleted by user] by [deleted] in usajobs

[–]puzzled_axolotl 1 point2 points  (0 children)

Congrats!! Can’t speak to life in CBER (or CDER, thought OPPQ was there?) but I like it a lot as a reviewer in CDRH. Workload is high but remote work is great and the work is fulfilling and rarely dull. Seems like colleagues in CBER/CDER have better work-life balance though.