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.
Pharma Business Analyst
Location: Fort Worth, TX
Duration: 6+ Months
Role Overview:
The Business Analyst will serve as a key liaison between business stakeholders and technical teams, ensuring successful implementation of regulatory changes within the Global Pharma and Medical Devices domain. This role requires strong domain expertise, excellent communication skills, and hands-on experience with GxP applications.
Key Responsibilities:
• Demonstrate a deep understanding of global pharmaceutical and medical device regulatory processes.
• Act as the primary liaison between business and technical teams for planned regulatory changes.
• Work extensively with GxP-compliant applications.
• Analyze and document RIM (Regulatory Information Management) configuration, GenAI custom solutions, and integration requirements.
• Translate business requirements into EPICs and user stories, including detailed acceptance criteria.
• Possess strong knowledge of RIM modules such as registration, submission, publishing, and submission archive.
• Collaborate with technical implementation and testing teams to clarify requirements and support execution.
• Assist the testing team in creating necessary data during the validation phase.
• Coordinate with offshore RIM and AIA developers, architects, business analysts, and testing teams to ensure alignment and timely delivery of tasks.
• Engage with business SMEs and client integration teams to validate requirements and solutions.
• Facilitate meetings between technical and business teams to drive clarity and consensus.
• Exhibit excellent written and verbal communication skills for effective stakeholder engagement.
Qualifications:
• Proven experience in regulatory processes within Pharma and Medical Devices.
• Hands-on experience with GxP applications and RIM systems.
• Strong understanding of integration requirements and custom solution design.
• Ability to manage multiple stakeholders and coordinate across global teams.
• Hands Experience with Veeva Vault RIM Application.
Thanks and Regards!
Lavkesh Dwivedi
Amtex System Inc.
28 Liberty Street, 6th Floor | New York, NY - 10005
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