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Amtex System

14 jobs near Columbus, OH

Amtex System Inc.

IT Support Analyst

Montgomery, IL · On-site

Amtex Systems Inc is an information technology and talent solutions company offering talent and BI consulting to the companies in US for over 25 years. Our solutions are designed to fill resource ...

Amtex System Inc.

Datacenter Technician

Orangeburg, NY · On-site

Amtex Systems Inc is an information technology and talent solutions company offering talent and BI consulting to the companies in US for over 25 years. Our solutions are designed to fill resource ...

Regulatory Business Analyst - GenAI & RIM (Pharma & Medical Devices) in Fort Worth, TX

Amtex System Inc.

Fort Worth, TX • On-site

Other

Posted 11 days ago

Job description

Amtex Systems Inc is an information technology and talent solutions company offering talent and BI consulting to the companies in US for over 25 years.

Our solutions are designed to fill resource gaps, by providing the right candidates who deliver value to the organization. Our propensity to nurture and build strong relationships with our clients helps us better understand their business demands and gives us the ability to provide services that are on time and rise above the rest.


Regulatory Business Analyst – GenAI & RIM (Pharma & Medical Devices)

Location: Fort Worth, TX
Duration: 6+ Months
 
 
 
Required Qualifications
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Regulatory Affairs, Computer Science, Information Systems, or related field.
  • 7+ years of Business Analysis experience within Pharmaceutical, Biotechnology, or Medical Device industries.
  • Strong experience in Regulatory Affairs and Regulatory Information Management (RIM).
  • Hands-on experience with Veeva Vault RIM.
  • Strong understanding of GxP, CSV/CSA, and regulated system environments.
  • Experience documenting business requirements, process flows, user stories, and acceptance criteria.
  • Experience working with Agile and Scrum methodologies.
  • Strong stakeholder management and communication skills.
  • 2+ years of experience working on Generative AI initiatives, AI-powered business solutions, or intelligent automation programs.
  • Understanding of Large Language Models (LLMs) and GenAI concepts.
  • Experience defining GenAI use cases, business requirements, prompt workflows, AI governance requirements, and evaluation criteria.
  • Exposure to GenAI platforms such as Azure OpenAI, OpenAI, Google Gemini, Anthropic Claude, or similar technologies.
  • Experience with AI-assisted document processing, summarization, search, content generation, knowledge management, or regulatory intelligence solutions.
  • Understanding of responsible AI principles, model limitations, hallucination risks, and validation approaches in regulated environments.
 

Thanks and Regards!

Lavkesh Dwivedi

 
Amtex System Inc.

7 World Trade Center, 46th Fl, Suite 4625

250 Greenwich Street

New York, NY 10007


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