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Infotree Global Solutions · 11 hours ago

Admin Coordinator (Veeva Vault RIM)

Thousand Oaks, CA

Contract

Hybrid

Entry, Mid Level

$23/hr - $25/hr

2+ years exp

Infotree Global Solutions is seeking an Admin Coordinator to manage day-to-day administrative responsibilities and support project initiatives. The role involves overseeing the US FDA Certificate of Pharmaceutical Product process, serving as a liaison for issue resolution, and providing analytical support for special projects.

Human ResourcesStaffing AgencyTechnical Support

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Manage the complete US FDA Certificate of Pharmaceutical Product (CPP) process — from application drafting and submission to Health Authorities through delivery to international destinations

Serve as the primary liaison between FDA and internal requestors for issue resolution and coordination of updates to ensure timely communication and document modifications

Initiate and manage the authentication process for CPPs by the US State Department, Embassies, and Chambers of Commerce, to final dispatch to international destinations

Track and manage CPP applications through various stages of process lifecycle

Support the State Licensing team by routinely monitoring the physical mailbox, scanning documentation, and coordinating shipment of hard-copy materials via U.S. Mail and courier services

Manage the authentication process for country-specific documents across products, modalities, sites, and phases of development

Obtain required document authentications and coordinate timely dispatch to appropriate end users (e.g., health authorities, local regulatory representatives, client partners)

Archive documents in accordance with established procedures and regulatory requirements

Maintain authentication process documentation and provide training to CMC staff on authentication workflows and requirements

Work onsite 1–2 days per week to coordinate notarization and obtain signatures as needed to meet regulatory timelines

Assist Regulatory teams with managing CMC Compendial Monographs from European Pharmacopeia (Ph.Eur), US Pharmacopeia (USP), and Japanese Pharmacopeia (JP)

Provide analytical support and follow-up for special projects and initiatives, including issue resolution related to invoicing and document management

Leverage digital tools (e.g., Smartsheet or similar platforms) to automate workflows, track deliverables, and maintain accurate documentation

Maintain shared resources and documentation on SharePoint and Microsoft Teams

Check and provide FDA Forms (1571 and 365h) to USRLs/RPs/CMC as needed

Anticipate challenges and resolve issues proactively using sound judgment and diplomacy

Qualification

Veeva Vault RIMDigital literacyProject managementOrganizational skillsCommunication skillsInterpersonal skills

Required

Expert knowledge of Veeva Vault RIM

High level of digital literacy with a variety of tools (e.g. Smartsheet, Miro, MS Copilot, ChatGPT Enterprise, Tableau) with a willingness to learn and adapt to new tools

Ability to handle multiple tasks and deadlines in a fast-paced environment