IT Business Partner, R&D, Compliance

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $120k - $150k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 2%

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Elevar Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $20M Venture Round - Elevar Therapeutics on 2018-07

Biotechnology • Pharmaceuticals • Healthcare

Elevar Therapeutics is a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. With a foundation rooted in oncology, the company is dedicated to identifying and developing promising medicines for complex and under-treated health conditions across a range of therapeutic areas. Elevar Therapeutics takes a relentless and inventive approach towards advancing next-generation therapies that aim to set new standards of care and improve patient experiences, all while maintaining the highest ethical standards.

📋 Description

• Serve as the strategic and operational bridge between R&D functions and IT • Act as the primary IT partner for designated R&D functions, including Regulatory Affairs, Quality, and Clinical Development • Build and maintain account and relationship plans • Own the strategy, roadmap, and lifecycle for Veeva R&D systems, including Veeva Vault QMS and Veeva Vault RIM • Translate business and regulatory priorities into technology plans, effort estimates, and prioritization within IT investment cycles • Lead or oversee system configuration, validation, and change control activities for Veeva platforms in a GxP-regulated environment • Partner with Quality and Regulatory stakeholders to support evolving compliance requirements, including 21 CFR Part 11, GxP, and global submission standards • Build business cases for platform enhancements, integrations, and new capabilities; manage associated budgets • Coordinate with enterprise architecture, data, and security teams to integrate Veeva and adjacent R&D systems as global solutions • Manage relationships with Veeva and other third-party vendors and implementation partners • Communicate project status, risks, and escalations to IT and R&D leadership • Mentor junior IT business partners or analysts supporting the Veeva platform portfolio • Identify opportunities for automation, AI/ML, or process improvement within QMS/RIM workflows • Report to the Chief Financial Officer

🎯 Requirements

• Bachelor's degree in IT, Life Sciences, or related field • 8 years in a client-facing IT role within pharma/biotech, with increasing responsibility • Experience managing regulatory compliance globally • Hands-on experience with Veeva Vault QMS and Veeva Vault RIM, including configuration, validation, or business ownership • Strong understanding of GxP-regulated environments • Knowledge of computer system validation (CSV/CSA) • Knowledge of change control processes • Experience with regulatory submission processes and/or quality management processes in pharma R&D • Ability to translate business/regulatory needs into technical requirements and delivery plans • Strong stakeholder management and communication skills across technical, scientific, and regulatory audiences • Experience building business cases and managing project or platform budgets • Veeva-specific certifications, such as Veeva Vault QMS or RIM Administrator, a plus • Post-market compliance experience, a plus • Ability to demonstrate Elevar's core values, including accountability, collaboration, ingenuity, and compassion

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Time off • Retirement plan • Other voluntary benefits • Remote-based work arrangement