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Admin CoordinatorUS Tech Solutions • Newbury Park, CA, United States
Admin Coordinator
US Tech Solutions • Newbury Park, CA, United States
2 days ago
Job type
- Full-time
Job description
Job Title
This role involves day-to-day administrative responsibilities onsite and leading and supporting several project initiatives as needed.
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.
Day to Day 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 ATO 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, Company's 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 12 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.
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
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.
About US Tech Solutions
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Admin Coordinator • Newbury Park, CA, United States
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