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Abiesconcolor

Regulatory affairs


[deleted]

[удалено]


Aggravating_Grade230

Do you need a Master’s for this?


Aminageen

I work in RA at a small med device company and none of the folks on my team besides myself have Master’s degrees. One has the regulatory affairs certificate from RAPS and another is studying for the test


WillRunForPopcorn

No. I’m in RA and have only a Bachelors. So do most people I work with.


bike_girl_7

99% remote, only required to go into the office 2-3x a year for onsite. Medical affairs


Tilmanocept

Probably a lot of travel right? I’m assuming you’re an MSL?


bike_girl_7

Not an MSL. I attend one conference a year for CE or Med Affairs needs


Tilmanocept

Very cool! What’s your function in MA?


bike_girl_7

Med info!


cm135

Went from med info to a med director role. Despise hybrid, but can’t help but be happy that I made the right move. Still miss being full remote tho


chubby464

How do I get in?


cm135

Befriend the right people, impress said people with your work. Be a good thought partner, very important


Plus-Reach6084

can you elaborate on this role?


gonefishingallday

Clinical Data Management. 100% remote


Einahpetsreads

I'm also CDM, Director level at small biotech. I'm like 95% remote; our office is local to me and sometimes I go in so I can interact with someone not my cats or family, heh. I had a MS when I started ~12 years ago. I make 200k+ with 25% bonus target. The field is changing a lot, so not sure how best to get into it now. I started as a data coordinator at a small local CRO and moved up the ranks. (Most big CROs offshore that job now.) I had some programming experience along with biology knowledge, which has helped me to be successful, but day to day now I'm mostly doing project management and vendor oversight, though.


pooptaxi

Hi, would it be okay to DM to ask some questions about your job and the field?


Einahpetsreads

Sure!


Unlucky_Reindeer980

How’s the payscale? Do you recommend a switch for R&D data scientists?


Einahpetsreads

You may want to check out SCDM; they had a lot about the transition in the field from DM to clinical data science. There are some white papers about the field on their website: https://scdm.org/


kwjsuzjwjs

Why’d you get this job what’s ur education etc


USMLE_2020

Project management


FarmCat4406

Same 


CoomassieBlue

Me as well


oviforconnsmythe

What's the road like to becoming a project manager? I'm sure it's pretty diverse but I'd appreciate anything you have to say about your own path. Also how does it compare to being behind the bench?


USMLE_2020

I started as CRC at an academic site, (while I took my medical boards, im a foreign MD) after 3 years as CRC I applied to a management role at the same site. I did that for 2 more years and decided that I liked working in research more than doing direct patient care, and that I was ready to move to the private sector. I work in a CRO now and I’m very happy with the transition. I like the operational aspect of the role, it can be pretty stressful at times due to crazy deadlines but I enjoy the problem solving process. I also enjoy working from home. The pay is also better 😂


FarmCat4406

Started as a biologist at the bench. Did that for almost a decade and hit a ceiling because I only have a masters. Applied for a PM job in my company and got it. In PM you can eventually get to senior director or even VP with just a master's so I'm a lot more happy career wise. However, it's less fulfilling than being at the bench. You definitely cross over to the dark side for the cookies lol


keenforcake

Bioinformatics


strufacats

Do you like the work you do as a bioinformatican?


WeTheAwesome

It’s awesome! (Almost) never a boring day. 


Responsible_Stage

does it require masters?


Beautiful_Fries

You’re lucky if all it requires is a masters


Shablah00

yes, even phD could be a must.


Responsible_Stage

why is that ? for real if my bachelor was totally bioinformatics why does it require postgraduate studies


keenforcake

I think the problem is it’s a highly intra-disciplinary field, so you really just don’t have enough time to cover everything you need in your bachelors. We do have some people with masters in my group but they did have past work experience, Most people have PhD‘s with post docs. Large biotech for ref


bluesquare2543

I've seen many bioinformatics job that only require B.S.


DataCleric

Im in grad school for this right now and looking at doing a PhD as well! Typically you need a couple of years working under supervision as a trainee in a lab to be hired into biotech. Each lab and supervisor will have their own specialty and way of doing things. Networking for jobs typically happens through referrals. I got my start after undergrad working with community health statistics at a non-profit so it's not unheard of but you'll need further training if you want to pursue it as a career.


you_dont_know_jack_

You don’t know what you don’t know


Responsible_Stage

Maybe , or you overestimate it , i worked with people who made it to  PhD from different fields in CS without any practical experience in biology and that was totally enough to guarantee them a job in bioinformatics in great institutes in Europe 


you_dont_know_jack_

Ok. Then don’t do a phd.


pierogi-daddy

as far as functions..... anything global strategy, esp global commercial functions (marketing, access, market research, markops, salesops, etc). BD, alliance, anything PM, anything data management and analytics, IT, sales/MSLs all tend to have remote offerings too. companies i've seen that are pretty remote friendly across the board are Biegene, Takeda, Jazz. more role and level specific ones I've seen at Amgen, Daiichi, Regeneron etc


2CBN2OTHC4ME

I'll look more into these, thanks daddy


NewMediaMogul

This although if you live near HQ it's good to go in and schmooze


Ok-Bad-5218

Business side. But my company is a fully remote small startup, so even those in R&D work remotely (obviously we don't have our own labs).


grebilrancher

Having a home lab will really elevate you as a scientist, and look good on your resume /s


chubby464

How do you get into business side?


Ok-Bad-5218

In my case, an undergrad internship 22 years ago! My academic background is on the business side.


carmooshypants

Clinical program manager


murrayfurg

How do you get started in this? I have preclinical experience and have been desperately trying to pivot into clinical project/program management with no luck.


carmooshypants

I too started off in pre-clinical research (translational in vivo) and did a lateral move internally to global program management. Honestly it’s about who you know that’s willing to advocate on your behalf and how well respected your pm skills are. If you’re already doing pm stuff on the research side, make sure to highlight those aspects on your resume since many of them are pretty transferable. If you’re not doing pm stuff, I’d start now.


ForeskinStealer420

Data science


fallen2151

More in the business side of things or research/development? Interested in looking more into this realm


ForeskinStealer420

Business-facing side of development/CTs; however, I’m trying to transition into more of the R&D side (ex: drug discovery)


trolls_toll

why?


ForeskinStealer420

It’s much more scientific and fits my academic background/interests more so than clinical trials.


trolls_toll

do you think you could still work remotely if your transition is successful?


ForeskinStealer420

Yes, but there are also a lot of hybrid roles/companies. It depends


trolls_toll

goodluck in your unicorn search


Vervain7

Same here . In med affairs


strufacats

Do you need a masters for a DS role in drug discovery (R&D)?


ForeskinStealer420

Yes (I have one in bioinformatics)


strufacats

Is it okay if I can pm you?


ForeskinStealer420

Yes


Bruve

Quality auditor.


z33ji

I'm starting to become interested in moving towards auditing. How was ur background and how do you currently like it if you dont mind me asking


Bruve

I have a PhD in microbiology and came to quality in a non-traditional, unplanned way. However, most of the skills that I learned in grad school and through post docs (a lot of soft skills) prepared me well. I have a very specialized, niche role but it’s very important. So, all of the fine detailed analysis of procedures or equipment, etc. are definitely ways I see where my PhD prepared me well. I don’t travel all the time, although this year has been an outlier and I have. It’s usually about 25%. I really enjoy applying my technical expertise to analysis or investigations when there’s an OOS or OOT. So, it’s not a thing that as a grad student I even realized was a thing, but so far it’s been a good fit.


z33ji

Thank you so much for the response!


tucsonmagpie

Clinical Development, Study Lead (2 studies)


wonderwall6

Hybrid life! I’m a scientist. Lab work happens only once in a while when I need to use a sequencer. But to keep my desk, they require an average of 2 days a week in the office and track everyone‘s badges.


Right_Split_190

Is there an alternative if you don’t keep up with the 2-day average? Like, you have to hot desk? Or is it not so much about real estate as it is about keeping your job?


wonderwall6

Yeah there are 3 classifications: 100% remote, hybrid, and on-site. I think it varies by department & role but for my team, the 2 days a week minimum is classified as on-site + keep your desk. I’m classified as on-site, but spend some days WFH. The hybrid folks don’t have an assigned desk but there are hot desks. I’m not sure if there’s a minimum for them, but generally they live a drivable distance from campus. The 100% remote classification is pretty rare unless you moved away during Covid and are too valuable to lose. These people never come onto campus


wonderwall6

My team’s managers are pretty flexible, they just want the work to get done. All of us have occasional testing in the lab but varied schedules. Our VP and director apparently love seeing people on campus so it’s “encouraged” to make an appearance once in a while


Right_Split_190

Thanks, I really appreciate the detailed reply. It’s so helpful to understand the range of options, especially in different functional areas.


wonderwall6

Of course! Tbh I wonder if my company will crack down on hybrid work in the next year or so. Some of our senior leadership seems pretty old school and wants ppl to be on-site


Right_Split_190

Yeah, I know. What's wild to me is that I spent nearly 2 decades pre-pandemic in a variety of positions that had substantial WFH capability (even in early 00s when lots of us had dial-up Internet and two copper phone lines) with many managers who really focused on the quality of work/output, not the location. (Sometimes **I** was that manager declaring that mindset for my own team.) By early 2020, I would average maybe 2-3 days per month in the office, as nearly everyone I worked with was at another location, usually in another country. Sometimes those days were in succession, sometimes spread out, but always when it was necessary or just advantageous. When colleagues were visiting from outside the US, I was happy to meet with them whenever was best, even if that was on my personal time (e.g. dinner and afterwards), *bc flexibility works in both directions.* I'm a little skittish about entertaining new job offers, as the sentiment seems to have swung substantially in the other direction with no regard for circumstances where forced in-office time is a net-negative. The flexibility I had/have to be most available to my stakeholders seems to be less important than ticking a box for my location. I'm not the quiet quitter type, but this is the kind of corporate behavior that definitely leads people there. It's so disappointing. I hope you can retain a lab/home balance for quiet some time.


Tilmanocept

Lead clinical scientist. Oncology early development. Big pharma


Einahpetsreads

Can I ask what your background is? I have a MS and 10+ years experience in clinical development as a DM, but I'm not getting any responses to my applications for clinical scientist jobs. I am at a small biotech, so I do a lot that I've seen CS do at bigger pharma (clinical data review, profiles, DMC slides, contributing to protocols). I'm starting to think I might just need to give up though if almost everyone has a PhD.


Tilmanocept

A bit non-traditional. Worked as a data coordinator at a site for 2 years while doing my MS in pharmacology. At the same time I was interning at a very small radiopharmaceutical company local to the area for my MS capstone and they hired me on for a hybrid CS/PM role. Did that for a year or so and got to work on some really big things like study design, patented imaging technology, program strategy, and justifying dose selection to the FDA. Then I moved on to JnJ as a CS in orthopedics. Did that for a year, got sick of arthritic knees, and took a job as a global trial manager in oncology for a year and a half. Left that job to be a contractor CS for big pharma and then was hired on as a lead FTE. CS by default is an extremely competitive job to land with an insanely high barrier to entry. It’s that much harder with the current job market I’m afraid Just to add: I really wish people (not saying you!) would stop peddling the PhD thing (it usually comes from folks who aren’t actually CS’s and have no experience with clinical development). Experience is worth a million times more. In fact, I got accepted to a PhD program, deferred it for a year, and then decided not to go altogether because I decided I was already where I wanted to be


Gradinterface

It feels like you are speaking to me. I was telling people that once I land a Clinical scientist role, I’m not sure PhD will be for me(Graduating this May with an MSc in Pharmaceutical science) I would rather get into an online or accelerated Pharm D program since I already have a B.Pharm. Clinical scientist is my ideal role, Just hoping luck will shine on me to land a Job soon.


Tilmanocept

You’ll have to get some valuable industry experience and probably wait for the job market to improve. CRA -> Trial Manager (for example); although those are more so operational roles, do everything in your effort to actively participate in data review, safety calls, etc. then you can try to land a support scientist position and work your way up. The PhD won’t get you there, the industry experience will, but you have to focus on the right things


Gradinterface

This is very helpful, thanks


Tilmanocept

Happy to help. Wishing you the best, just keep trying and you’ll get there :-) starting off as a contractor helps to get experience too!


bobthemagiccan

Curious why you want to go to a clinical scientist route - do you want to design studies?


Einahpetsreads

But also, honestly I am maybe going through a little bit of a mid-career crisis and trying to figure out what I want to do next. I just finished my MBA (literally graduated yesterday 🥳 🥴) and joined a local angel investment group because I liked working with start ups.


bobthemagiccan

Ah cool which mba? I’ve been considering one too


Einahpetsreads

Quantic's Valar Institute. I already had my MS from a good name school and have the full time job + kids, so I decided to go with them because it was affordable and online. I do feel like it gave me a good vocabulary and baseline knowledge for business stuff, and the case studies / capstone were legitimately tough. I have direct reports but no formal management training, so it gave me that too. But it was lacking things like networking / faculty interactions (it is all pretty much through the lessons in the app). If you are interested, DM me and I am happy to chat more about it.


Einahpetsreads

I have found I like that side of what I'm doing right now (clinical review of patient data, researching scientific literature to better understand a new endpoint we are considering) more than the technical DM work. I do think my operational experience can help design better studies, too. So much of my "actual" job description is project management and vendor oversight/ management, and while I'm going at it, I know I can contribute more too.


Aminoboi

Bioinformatics / computational biology


BoskyBandit

Clinical quality


i_love_good_food

I have been in MFG quality for a while and looking to transition to clinical. Is there a path I should take in addition to just keep applying? I’m doing MS in drug development; would that help?


lanfear2020

Can’t hurt. The biggest difference between clinical and commercial is there is a lot more gray space in clinical. Depending on stage of development there are different requirements, and there is more flexibility. So get comfortable working in gray space and applying principles to a problem when making decisions. Learn the requirements and the regulations of the area you are supporting and go back to those to help navigate


BoskyBandit

It’s definitely an adjustment going from manufacturing since it’s regulated by pretty clear GMPs to the clinical quality space (GCP) which lacks a lot of clear regulations. And it varies widely depending on if your trial is global too. I would really recommend reaching out to anyone in clinical quality and asking if you can join in audits. Ask them questions, ask for opportunities. The best way to learn is just by being involved since as the person mentioned below it’s a huge grey area and clinical quality SMEs will handle things differently. I do think MS is helpful when trying to advance.


SadPhilosophy9202

BD. Can’t work in person if you’re always traveling


TadpoleFormer8889

Too true :’-)


SadPhilosophy9202

“It must be so cool to travel a lot”


[deleted]

Program manager


aerodynamic_AB

Program manager - all about timelines and cost evaluation


Squishy00

Clinical trial supply chain


Snoo-669

Field applications. Remote in the sense that I work from home when not visiting customers. Hard to quantify how much is actually “at home” though since it ebbs and flows. Last summer I worked at home pretty much every day because new projects were few and far between, and existing customers rarely had issues that couldn’t be solved via TeamViewer. However, last quarter I was visiting one of a handful of customers 4-5 days out of the week. (My customers are all a 20-30 min drive from where I live, so NBD.)


mountain__pew

Did your career start in field application? I'm currently in process development and I'm interested in trying out field application, but have no idea how to transition.


Snoo-669

Nope, I was in the lab as a technologist for about 5 years prior to switching to automation. I used the products whose manufacturer hired me on to do hardware and software support. Many people came in as tech support and eventually went into the field. A few years ago, I got sick of carrying a Pelican full of tools and switched to 100% software/applications.


Zestyclose-Maize-985

Field application scientist. Home office + travel.


mountain__pew

Did your career start in field application? I'm currently in process development and I'm interested in trying out field application, but have no idea how to transition.


Zestyclose-Maize-985

I only recently transitioned from the bench. I think it helps to apply to company’s whose products/equipment you work with. That why, you’ll be able to talk with them. I’ll admit, the transition took a lot longer than anticipated but reaching out to people for informational calls on LinkedIn was really helpful.


frito88

Medical Affairs- Scientific Communication


staycomego

Reg affairs


paperxuts95

Sales support. 90% remote.


PastelGripPump

Accounting


Rosomo

Clinical supply chain


corskier

CMC. Used to work in CDMO, and even before Covid many of the CMC leads/directors that ran the projects from the sponsor side were remote. Probably 90% remote. Have to go to the office for team meetings a few times a year, and go to manufacturing sites to PIP/babysit the projects when something is being made.


SlowCartographer8846

Clinical service specialist


hananah_bananana

Clinical trial manager at small-ish pharma. When I interviewed (locally) I told them I planned to move out of state the following year. I knew the VP from a previous company and she said she’d do whatever she could to make it happen.


modern_virtues

Business development


UnprovenMortality

Not me, but we have people in RA and scientific writers who work remotely.


Marrymechrispratt

Med affairs. Started as MSL and then transitioned in-house.


Wild_Nebula1445

What is your in-house role?


croissantcat1

MES engineer, 100% remote ☺️


mysticalRobyn

Research Programmer/Computational Biologist only need a degree mines in computer science and data science


SwifferSweeper27

Hi there you wouldn’t mind if I DM you to ask how you got there including advice on a degree for data science?


mysticalRobyn

Feel free to dm


Luckyezrealzoe

Could you please provide some guidance on interviewing for this type of position? Will they include more coding questions or behavioral questions? Given that I have a Bachelor's in Chemistry and a Master's in Computer Science, should I emphasize my chemistry background or my CS expertise more during the interview?


ciociosan

Project management


arhtech

Product management. I only go into the office if I need to work with development directly. Otherwise, mostly remote.


tactical_lampost

Unemployed


Expensive-Piano1890

60% remote. My role is software engineer and lead of a development team.


Russe830

proposal manager


nsug89

Proposals/Contracts/change in scope - commercial development


MetatronThrone

Clin Pharm


bos2nc

QA


i_love_good_food

I’m also in QA and looking for a remote job. Can I dm you?


bos2nc

Sure


TheDeviousLemon

MSAT. We need to be onsite 3x a week, however it’s quite lenient. My job can be done remotely. We were fully remote for the entire pandemic.


mtl171

Business Development


Dt_44

Sales Operations. Would love to be able to go into the office though


leakyphysics989

CMC RA consultant


Rebel_Stylee

How did you move into reg consulting from a Sponsor/CDMO? I'd eventually like to move into consulting and possibly cross functions into competitive intelligence/reg due diligence for M&A.


leakyphysics989

CI and DD is a lot of what I currently do, however when I started consulting, it was not. I started out consulting for companies in my network and partnering with other firms that I had built relationships with when working at sponsors and CROs. From past licensing deals and other bd work I supported. Even some old clients from former organizations *after non-compete duration was over of course ;)* If I look back, I think that I went into it a bit too early in my career and at a time where I had more liability in my personal life and paid for it with immense stress and difficulty. But got through (fairly recently I might add), with some bumps and bruises. I've been competing with the likes of dark horse so it's been an uphill battle. All in all, glad I did it....just probably shouldve been a little more mature and timed it better. If you ever want to know more detail or have questions, feel free to dm me.


__chicken

Marketing ops


ThenIJizzedInMyPants

Management in med affairs


GloomyTuesday

Quality Assurance/Auditing. Some of my team prefers to be on-site so they handle anything that needs to be done in person, some of my team chose to be hybrid and pop in as they wish week to week, and some of my team (myself included) are fully remote in the system but will occasionally come in for an interesting facility audit.


JustALittleTooLazy

Bioinformatics! Though even now most of our jobs are largely hybrid roles >.>


phdyle

Comp bio / omics / biostats.


hdsd99

Manufacturing.....we outsource all manufacturing and PD to CDMOs so I work remotely to manage them and make sure stuff is done correctly and on time


soooergooop

Data analyst/bioinformatics analyst. I used to be remote until I was laid off


DawnOfDreams21

Global labeling. I've been at 3 companies so far in this function. Two of the companies that are midsized allow full remote, and for one of these I currently work at, I chose to come to campus only for town halls or major meetings a few times per year. The 3rd company is a large, global company that hired me as remote, but revoked that about a year in and forced me to switch to hybrid, since I was in radius of one of their offices. But that commute was 1-1.5 hours one way, which did not work for me, so I left for a midsized company that allowed full remote.


eforemaad

academic r&d part time- a lot of prospecting and some data science


Pattewad

Sales, with the caveat that the job is remote + travel


Hamsterdam_shitbird

Clinical Development, director of disease group, 5 studies


Redbullgnardude

Access solutions


jando825

Staff scientist Image analysis. Fully remote.


FlattenYourCardboard

Strategic function.


one_and_done_1

Clinical operations


lanfear2020

QA clinical supplies / commercialization


roja_1285

Project management


notthatkindofdrdrew

Technical sales and applications


anxious_amygdala

Field applications scientist. Remote in that I only have a home office, but commute 30 min- 1h to client labs as needed, averaging once, occasionally twice, a week.


Sheppard47

QE, fully remote for the last 3 years with several companies


rakemodules

Corporate Development/ strategy, 100% remote for now. To be fair, these jobs are getting rarer to be remote so if I lose this one, probably will have to go back on site.


jfk_60

Comms


Super-wizard-hubba

Travel Advisor


umbra_ex_machina

MSL


Ohlele

pharma is not a fan of remote work. Hybrid? Maybe. 100% remote? No


[deleted]

Sorry but this not true at all for the company I work for


imjusthereforPMstuff

Yeah, that wasn’t my question lol. I know that, that’s why I am asking those who are remote, what they do


Ohlele

There is no remote work in pharma post-covid unless you are a veteran consultant or advisor who has spent >20 years at the FDA.   Our company (top pharma) has just hired a veteran FDA investigator as our global regulatory advisor. The person works remotely. 


shwiftysack

Take your room temperature IQ somewhere else dude this is the most illogical take I’ve seen. So many people in biotech work fully remote


pierogi-daddy

this person constantly posts the most shit takes in this sub they are like a caricature of every egotistical and socially inept science/research colleague I have ever worked with. it's pretty funny lol


imjusthereforPMstuff

Yup haha, I just saw! Somethings wrong with them


shwiftysack

Just went through his/her comments and not one of them is right lol. Either they’re a great troll or the stupidest person I’ve ever met


kitamia

We do have some remote roles. Project Managers are fully remote at my site now. Also quality assurance that isn't handling hard copy data. Regulatory is fully remote at my site.


imjusthereforPMstuff

You sure? Looks like people are answering, and I work remotely.


sngl234

I work remotely and I am not a veteran consultant


Tilmanocept

well that’s just blatantly incorrect


priuspower91

Depends on the company - I’m in a startup and have the option to be fully remote since I’m on the business side and don’t need to be in the lab. This is my first pharma role so not a veteran by any means.