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Director Real World Evidence Rwe Jobs in Utah (NOW HIRING)

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Compliance Officers

Provo, UT · Remote

$50 - $70/hr

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Author and review evaluation tasks inspired by real-world agency requests and sponsor response ... Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or ...

New

Your work will shape how models learn, reason, and perform through high-quality, real-world input ... Direct experience independently authoring or leading the authoring of full Clinical Study Reports ...

New

... real-world challenges. You'll work in close collaboration with faculty and residents to promote a ... Utilize evidence-based science in didactic and clinical teaching * Integrate Biomedical Science in ...

Your work will shape how models learn, reason, and perform through high-quality, real-world input ... Direct experience independently authoring or leading the authoring of full Clinical Study Reports ...

New

Showing results 41-60

Director Real World Evidence Rwe information

What is the difference between Director Real World Evidence Rwe vs Clinical Data Manager?

AspectDirector Real World Evidence RweClinical Data Manager
CredentialsAdvanced degrees (PhD, MD, or Master’s), industry certificationsBachelor’s or Master’s in life sciences, clinical research
Work EnvironmentStrategic, cross-functional teams, senior managementData collection, database management, clinical trial sites
Industry UsagePharmaceuticals, biotech, healthcare analyticsClinical research organizations, pharmaceutical companies

The main difference is that the Director Real World Evidence Rwe focuses on designing and leading real-world data studies to inform healthcare decisions, while the Clinical Data Manager handles the collection and management of clinical trial data. The Rwe director has a broader strategic role, whereas the Clinical Data Manager is more operational and detail-oriented.

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Regulatory Affairs Specialist

micro1 AI

West Valley City, UT • Remote

$50 - $70/hr

Part-time

Posted 3 days ago

New


Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory 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

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).