Admin Coordinator (Veeva Vault RIM)

Description:

Onsite

Standard business hours

Job Details: This role involves day-to-day administrative responsibilities onsite and leading and supporting several project initiatives as needed:

Top 3 Must Have Skill Sets:

• 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.

• 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.

Preferred Qualifications

• Proven experience coordinating with cross-functional teams and driving process improvements.

• Strong organizational skills and attention to detail.

• Excellent verbal and written communication skills.

• 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.

• Strong interpersonal skills with the ability to influence and engage stakeholders at all levels.

Basic Qualifications

Associate degree and 2 years of experience OR 2 years in a technical school setting with hands-on experience OR High school diploma / GED and 4 years of experience