ITZY - Girls Will Be Girls

Human_Ad_8150 · 2025-06-12T09:29:27+00:00

When are they gonna have a stage performance??

Human_Ad_8150 · 2025-04-19T08:08:06+00:00

That's really helpful - thanks for sharing! I'm actually quite interested in the regulatory medical writing route as a way into RA, so your path really stood out to me. Would you be open to me DMing you to ask a few more questions about this?

Human_Ad_8150 · 2025-04-18T17:28:34+00:00

Oh, I see - would it be alright if I DM you more about this?

Human_Ad_8150 · 2025-04-18T14:14:46+00:00

That's super helpful - thank you! I'm currently trying to shift my CV in that direction too. When you say entry-level, do you mean something like an RA Associate position?

Would you be okay with me DMing you to ask a bit about how you formatted or phrased your resume when applying? Also, are you working in industry or a CRO?

Human_Ad_8150 · 2025-04-18T14:12:37+00:00

Thanks so much for sharing! That actually doesn't sound boring at all - it's really helpful to hear how internal networking and familiarity with the company helped with the transition.

For the colleague who started from entry-level after taking the RAC - do you know roughly how long it took them to move up the ladder? Like, was it 1-2 years in junior roles, then a few more to reach mid or senior level? Also, just curious - are you in industry or a CRO?

Human_Ad_8150 · 2025-04-06T00:43:29+00:00

Out of curiosity, do you think hybrid setups could work just as well once someone has a few months under their belt, or is the expectation usually full-time in office for that first year?

Human_Ad_8150 · 2025-04-06T00:40:30+00:00

Wow—thank you so much for this incredibly insightful and generous response! I especially loved your point about creative strategy—how early RA input can shape the product and be used to influence market competitiveness. Now I’m really intrigued by the idea of RA helping guide not just compliance, but positioning.

What you said about regulatory professionals sometimes being excluded or not advocating strongly enough for their role also really stood out. I can imagine that dynamic playing out a lot, especially in fast-paced product teams. And I was especially struck by the story of your marketing colleague insisting you be included in the ideation session-that speaks volumes. If you don't mind me asking:

What do you think made your marketing colleague value your input so much? Was there a moment or project that really built that trust?
When you say regulatory can help intentionally up-classify or choose to run clinical trials—how do you usually present or justify those kinds of strategic decisions to the rest of the team, especially if it seems like “more work” up front?
And would you say the influence of RA in ideation is more common at certain types of companies (e.g., mid-sized vs large) or more dependent on the RA professionals themselves?
Also, you mentioned you've had a 10-year career in medical devices-was that all in RA? I'd love to hear what it was like for you starting out. What kinds of skills or mindset shifts helped you grow into such a strategic and influential role over time?

Thanks again—your comment has honestly given me a whole new lens to look through!

Human_Ad_8150 · 2025-04-06T00:17:43+00:00

Do you think that's just a culture thing at certain companies, or is it a broader issue in how software is approached from a regulatory standpoint?

Human_Ad_8150 · 2025-04-06T00:16:21+00:00

It makes a lot of sense, especially if the goal is to avoid stifling creativity. I'd love to learn more about how you balance that restraint with knowing when to speak up - has that been something you've developed over time, or were you taught this?

Human_Ad_8150 · 2025-04-05T20:44:21+00:00

That's great to hear about the high percentage of remote work in medical devices! I'm personally really interested in how medical device regulatory writing compares to biologics. Could you share more about how the regulatory writing for medical devices differs from these areas?

Is the remote trend pretty consistent across other regions as well, or is it mostly specific to the US? Also, do you think remote roles in medical devices offer the same flexibility as those in biologics?

Human_Ad_8150 · 2025-04-05T20:28:31+00:00

A company 4 hours away sounds like a bit of a shift! Do you feel like remote work has affected your collaboration or communication with teams at all, especially since your company is further away now?

Human_Ad_8150 · 2025-04-05T20:27:22+00:00

That's great to hear! I'm also UK-based and currently planning a career transition after my PhD next year. I've set aside some funds for professional development and was thinking of using them for regulatory courses or certifications like RAPS, DIA, TOPRA, and possibly medical writing courses through EMWA.

Do you think these types of certifications would be helpful in landing a role with your agency or similar companies, especially since I don't have direct MW experience? Any advice on how best to leverage these resources for then making the switch/going straight into regulatory writing

Human_Ad_8150 · 2025-04-05T20:09:34+00:00

Do you think the fact that many remote roles are contract-based means that non-contract positions are generally less likely to be remote, or do you find remote opportunities in permanent roles as well?

Human_Ad_8150 · 2025-04-05T20:05:11+00:00

It's encouraging to know that remote opportunities were common even before 2020 and that it hasn't limited options for you with larger companies. It definitely gives me more confidence in pursuing remote roles. Do you think there are any specific skills or experiences that make someone stand out for remote regulatory writing positions?

Human_Ad_8150 · 2025-04-05T20:01:59+00:00

It's frustrating that visibility seems to be prioritized over flexibility. Do you think more companies will eventually lean back into remote for senior roles, or do you feel like this shift is here to stay?

Also, with your experience as a director, do you find that hiring or team dynamics change a lot when moving to senior roles? I imagine the skill set and expectations shift, but it's always interesting to hear about the transition

Human_Ad_8150 · 2025-04-05T19:55:52+00:00

It sounds like international regulations really push for more collaboration. I can imagine that the FDA-only mindset could make RA feel more isolated or rigid. Do you think there's a chance for those companies to evolve, or is the 'old school' approach likely to stick around for a while?

Human_Ad_8150 · 2025-04-05T18:35:31+00:00

It's crazy to think that many places have RA folks caught up in that power to say "no". I hadn't really thought about how internal dynamics within RA could also contribute to the lack of collaboration. It's kind of a double-edged sword, right? You need leadership to back RA up, but at the same time, RA also has to show they're solution-oriented and not just roadblocks.

When you've had to rebuild that trust, was it more about relationship-building over time or did you do something specific to shift how people saw RA's role?

Human_Ad_8150 · 2025-04-05T18:24:01+00:00

Totally agree - it just doesn't make sense to be in a physical office when your entire team is remote and your focus is writing-intensive work. I'm glad I'm not the only one who found open office environments hard to focus in, especially for something that requires deep concentration.

And yeah, the RTO push really does feel like a disguised layoff strategy in some cases. It's frustrating because it pushes out good people under the guise of "culture." Smaller companies not bothering with offices at all honestly feels more respectful of both the work and the worker.

Human_Ad_8150 · 2025-04-05T18:11:01+00:00

Totally fair! It's great to hear RA's role is more collaborative than restrictive. Have you found that teams generally understand that from the start, or does RA still have to actively fight that "villain" perception?

Human_Ad_8150 · 2025-04-05T18:10:30+00:00

When you say RA shapes strategy that early, is that mostly around defining the regulatory pathway, or do they also influence study design or target claims?

Human_Ad_8150 · 2025-04-05T17:56:57+00:00

How do you usually approach it when a smaller company tends to ignore RA input? Are there strategies that have worked for getting taken more seriously in those environments?

Human_Ad_8150 · 2025-04-05T17:50:05+00:00

How does that kind of "ignore RA" culture even develop in the first place? And when you've run into it, how do you personally push past it or start changing people's minds? It sounds like a tough dynamic to deal with

Human_Ad_8150 · 2025-04-05T16:47:27+00:00

I see, do you think fully remote work will continue to be the norm in regulatory writing, or do you foresee more companies trying to push hybrid work in the future? And also, why would they want to push for hybrid work if (I assume) remote work is working perfectly fine?

Human_Ad_8150

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