ZipRecruiter

Log In

1

Clinical Affairs In Usa Jobs in Indiana (NOW HIRING)

micro1 AI

Regulatory Affairs Specialist

Fishers, IN · Remote

$50 - $70/hr

... in both written and verbal form. Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.

micro1 AI

Regulatory Affairs Specialist

Carmel, IN · Remote

$50 - $70/hr

... in both written and verbal form. Preferred Qualifications * 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.

IN USA

Kidney Care - Patient Care Navigator

Indianapolis, IN · On-site

$16.75 - $22/hr

  • Retirement

Assists patients with self-care needs including addressing language and cultural barriers as well as coaching patients to meet personal and clinical goals. Identifies patients in need of intensive ...

Cynet Systems

Janitor

Princeton, IN · On-site

$11 - $16/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Princeton, IN, USA Job Type: Contract Job Overview: Pay Range: $11.00hr - $16.00hr Requirement/Must ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...

Progressive Medical Inc

Be Seen First

Medical Sales Representative

Indianapolis, IN · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

A Clinical Affairs Team that is available to answer questions and provide peer to peer training and support to our customers. * Sales Education in collaboration with the Marketing Team provide ...

previous pagenext page

Showing results 21-40

All JobsClinical Affairs In Usa JobsClinical Affairs In Usa Jobs in Indiana

Clinical Affairs In Usa information

What is the difference between Clinical Affairs In Usa vs Clinical Research Associate?

AspectClinical Affairs In UsaClinical Research Associate
Required CredentialsTypically requires a degree in life sciences, nursing, or related field; certifications like CCRP or RAC are commonOften requires a degree in life sciences; certifications like CCRP are advantageous
Work EnvironmentWorks within pharmaceutical or biotech companies, overseeing clinical trial processes and complianceWorks on-site or remotely, monitoring clinical trial sites and ensuring protocol adherence
Employer & Industry UsageUsed mainly in pharmaceutical, biotech, and medical device industries in the USCommonly employed by CROs, pharmaceutical companies, and research institutions

While both roles involve clinical trial processes, Clinical Affairs In Usa focuses on regulatory compliance, strategy, and overall clinical program management, whereas Clinical Research Associates primarily monitor and coordinate trial sites to ensure protocol adherence. Both roles require similar credentials and are integral to the clinical research industry in the US.

What are popular job titles related to Clinical Affairs In Usa jobs in Indiana?

For Clinical Affairs In Usa jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Clinical Affairs In Usa jobs in Indiana look for?

The top searched job categories for Clinical Affairs In Usa jobs in Indiana are:

What cities in Indiana are hiring for Clinical Affairs In Usa jobs?

Cities in Indiana with the most Clinical Affairs In Usa job openings:

Clinical Affairs In Usa jobs near you

Regulatory Affairs Specialist

micro1 AI

Fishers, IN • Remote

$50 - $70/hr

Part-time

Posted 15 days ago

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).

Apply