Regulatory Operations Principal Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary:

This role has primary responsibility as the Business System Owner of the Veeva PromoMats system, the primary compliance system used by >300+ Vantive team members globally across Commercial, Legal, Medical Affairs and Regulatory, to facilitate the Corporate Advertising and Promotions process. Secondary responsibility includes owning and resolving data governance requests across the Veeva RIMVault system.

Essential Duties and Responsibilities:

• Serve as the Business System Owner of Vantive’s PromoMats (Veeva) system. This includes leading the Vantive cross-functional user community through quarterly planned releases and ad hoc change requests that require test script development, authoring, verification/validation testing & system approval to ensure data integrity with limited down-time
• Proactively communicate upcoming system changes to 300+ Vantive team members and provide / support team member training commensurate with magnitude of system change being implemented.
• Immediate triage and drive resolution of business administrator requests submitted through request portal for PromoMats. Assign work to others as needed.
• Maintain the PromoMats system in a validated state and provide front-line support defending validation status in internal and external audits, in conjunction with Vantive IT and IT-QA.
• Provide leadership, mentoring, and daily work instruction and oversight to PromoMats data governance resources within Global Regulatory Operations. Train resources to serve as back-up PromoMats Business System Owner.
• Lead and drive Systems-related continuous improvement efforts to maximize resource utilization, knowledge sharing, and process efficiency.
• Own, author, and maintain Standard Operating Procedures, User Guides, Work Instructions, and Training Materials related to PromoMats and RIMVault systems.
• Successfully complete assigned data governance requests for the RIMVault system, serving as part of the RIMVault data governance team which triages RIM requests submitted through the request portal.
• Maintain awareness of regulatory requirements and evaluate potential impact to Vantive systems.
• Cross-train on US Submission Coordinator role and act as back-up, when requested.

Qualifications:

• Demonstrated expertise and proficiency using the Veeva PromoMats and Veeva RIMVault systems.
• Previous experience / history as a business system owner / business administrator for a validated computerized system.
• Excellent organizational skills and ability to support multiple projects
• Strong written and verbal communication skills
• Ability to independently identify compliance risks and resolve or escalate when necessary
• Able to work independently with minimal direct supervision, and to provide work instruction to other team members that may not be co-located
• Experience using Microsoft Office and SharePoint will be an advantage.

Education and Experience:

• Bachelor’s degree or county-equivalent, with 5 – 7 years of relevant experience in a regulated environment.

At Vantive, we are committed to fair and transparent pay practices and to creating an environment where people feel valued and supported. We know that compensation matters when considering a new role.

The minimum annual base salary for this position is €40,800. Your starting salary may be higher, depending on factors such as your skills, experience, qualifications, and the unique perspective you would bring to the role. 

We carefully consider each candidate individually while also ensuring fairness and consistency across our organization.

In addition to base pay, this position may be eligible for a competitive (bonus and) benefits package designed to support your well-being, professional growth, and life beyond work.

If you decide to apply, we encourage you to speak with our Talent Acquisition Team, who will be happy to discuss compensation, benefits, and what it’s like to be part of Vantive. 

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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