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RxCloudRX

BA Regulatory Business Analyst

RxCloud is a professional services organization focused exclusively on providing quality assurance, compliance, and IT solutions for the pharmaceutical, biotechnology, and medical device industries.

RxCloud

Employee count: 11-50

United States only

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JD:

Business Analyst with Regulatory Affairs Merger & Acquisition experience, Regulatory data migration experience who can manage and execute project, gather requirement, collaborate, efficiently communicate, and represent IS Reg Affairs workstream to program and have proven ability to creative thinking.

Responsibilities:

  • Efficiently lead the conversation, gather requirements from Business, understand the concerns, identify the risk, and communicate it promptly.
  • Represent the IS Regulatory Affairs workstream to the broader Program team, and responsible for providing project updates/statuses on a regular basis
  • Ensure document/data imported/exported into/from the Veeva RIM system by following multiple cross-functional requirements (e.g., Security, Quality, cross-functional Business, Legal)
  • Coordinate with the migration team to execute data migration/export into/from Regulatory Affairs/relevant systems
  • Create a project plan, manage, and execute it. Work with the Onsite-Offshore team and ensure delivery of work on time.
  • Work with multiple vendors to execute the project.

Preferred:

  • Working knowledge of Veeva Vault RIM is preferred.
  • Authored and review Data Migration Plan
  • Experience with HP Application Lifecycle Management (ALM)

About the job

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Job type

Full Time

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Location requirements

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United States +/- 0 hours

About RxCloud

Learn more about RxCloud and their company culture.

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RxCloud is a professional services organization focused exclusively on the pharmaceutical, biotechnology, and medical device industries. The company positions itself as a full-scale quality assurance and professional services organization, dedicated to driving innovation and ensuring compliance across the life science sector. Nestled in Silicon Valley and incorporated in California in 2020, RxCloud was founded by a collective group of industry experts with diverse expertise spanning pharmaceuticals, biotechnology, and medical devices. Their shared mission is to empower Life Science companies with cutting-edge quality and compliance IT solutions.

The company's core services revolve around quality, compliance, and innovation. RxCloud specializes in GxP Audits (GMP, GDP, GLP, GCP, GVP) as a service, Computer System Validation (CSV) services, Veeva services, and Software Quality Assurance services. Their offerings also include Quality Management System (QMS) consulting, end-to-end global audit management, CAPA management, and SOP authoring. RxCloud emphasizes its ability to bring speed and agility to achieving compliance effectively and efficiently, enabling clients to focus on their core business. The company highlights its experience, with a core team possessing over 1000 years of cumulative life science experience. They have expanded their operations to include a development center in Chennai, India, and have established a presence in Canada, alongside their US operations. RxCloud aims to be a trusted partner, driven by innovation, agility, and a client-centric approach, providing cost-effective and rapid solutions to meet and exceed business needs in the life sciences.

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RxCloud

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