Medical Writer (Pharmaceutical)
Micro1 • Remote
Education
PhD
Type
Hourly
Pay Rate
$30–$60/hr
Actively Hiring
30 openings
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From the Micro1 listing
Role Title: Medical Writer (Pharmaceutical) Role Type: Contractor Location: Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters. Scope of Work
- Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
- Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
- Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
- Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
- Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
- Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI. Preferred Qualifications
- Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
- Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
- Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
- Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
- Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
- Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
- Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued. Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.
Requirements
- regulatory medical writing
- clinical study report authoring
- ich e3 guidelines
- scientific accuracy assessment
- source data verification
- clinical protocol interpretation
- tfl (tables, figures, listings) analysis
How long hiring takes
Across the AI training platforms we refer candidates to, the median gap between referral and hire is about 30 days. It varies by platform and role, so treat it as a rough guide for this one.
Key responsibilities
- Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
- Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
- Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
- Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
Why this role
This Medical Writer (Pharmaceutical) role pays $30–$60/hr fully remote, so the Writing work here isn't limited to whoever happens to live near an AI lab's office.
Talent pool
We're light on Writing candidates
We've matched 30 people with a Writing background against 397 Writing listings we've tracked, so most go out without one. Set up a profile and we'll consider you for a role like this one.
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Common questions
Does Micro1 monitor your computer while you work?
On many projects, yes, through time-tracking tools that take periodic screenshots to verify active hours. Check the specific project's requirements before accepting if desktop monitoring is a dealbreaker.
What does the Micro1 application process look like?
Expect a screening interview with Zara, Micro1's AI recruiter. Prepare for it like a real video call: good lighting, clear audio, verbal answers to technical questions. A human manager reviews the recording afterward, and some roles add a short skills assessment on top.
Do creative AI training roles allow creative freedom?
Some, within limits. You're hired for your talent, but most projects still require following strict style guides, like keeping a neutral tone or matching a technical-manual style. Consistency across the dataset matters more than personal expression here.
What equipment do I need for creative AI training roles?
For voice or audio roles at this pay level, a professional home studio setup (XLR microphone, acoustically treated room) is typically required. Phone recordings and laptop mics usually get rejected by quality control.
What does Writing work look like for a Medical Writer (Pharmaceutical)?
Tasks here are scoped to Writing, not generic labeling. As a Medical Writer (Pharmaceutical), expect to draw on real domain judgment (evaluating outputs, correcting errors, or providing expert reasoning specific to Writing) rather than following a one-size-fits-all rubric. If you don't have hands-on Writing background, this is likely not the right listing to start with.
What specific skills does this listing call for?
regulatory medical writing, clinical study report authoring, ich e3 guidelines, and scientific accuracy assessment are named directly in the listing. If you don't have hands-on experience with these, expect the screening process to test for them directly rather than accepting adjacent experience as a substitute.
What does the 'openings' count on this listing mean?
It's Micro1's live count of how many candidates it's still trying to place for this specific role, 30 right now, not a countdown on your individual application. A higher number signals more active demand; it doesn't lower the bar for acceptance.
How much does this specific role pay?
This listing is posted at $30–$60/hr, an hourly rate. The range reflects experience level and negotiated terms, not a placeholder, so where you land in it depends on your background and the assessment. Pay can change between when we last checked the listing and when you apply, so confirm the current number on the platform's own application page before committing time.
What happens when I click Apply on this listing?
You'll be taken to Micro1's external site to complete your application there. This listing links through a referral, but the process is identical to applying directly; the link just routes you correctly. Create an account on their site and follow their onboarding steps.
Is a PhD required?
For this specific role, yes, or near-equivalent professional depth. The credential gate is enforced at the assessment stage, not just on paper. That said, active PhD candidates and people with equivalent published research have qualified without a formal degree. The assessment is the real filter.