R&D and Regulatory Systems Lead

🕒 September 23

🇺🇸 United States – Remote

💵 $95k - $193k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 24%

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Viatris

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Healthcare • Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

📋 Description

• Work with Regulatory Affairs and other R&D functions to understand technology needs and ensure global processes and systems are compliant • Provide working knowledge of digital capabilities supporting global R&D business processes • Monitor emerging global health authority requirements and assess system impact • Collaborate with business users to identify needs and translate them into technical requirements • Gather functional requirements, model processes, conduct interviews, develop user stories and prototypes, map data flows, and perform root cause analysis • Administer and develop Veeva RIM Vaults, including package software implementation and Vault API integrations • Lead RIM Vault administration, enhancements, fixes, configurations, and code migrations • Lead technical design for assigned projects and enhance system integrations • Design, architect, and lead development of complex applications • Manage projects through implementation, delivering within scope, schedule, and budget • Work with global teams on end-to-end R&D solution implementations • Ensure compliance with FDA, EMA, and other health agency regulations • Drive compliance with IT Quality and Viatris SDLC processes, including change management and testing • Collaborate with solutions leads and business partners to ensure technologies meet business requirements • Support vendor relationships and escalate system issues promptly

🎯 Requirements

• Bachelor's degree in science, IT, or a relatable field • Veeva RIM Vault certification preferred • 10 years of Regulatory business process knowledge and strong hands-on technical experience configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions • 10 years’ hands-on experience with software design and development, system integrations, and analytics report builds • Prior experience in the pharmaceutical industry and a solid understanding of R&D and Regulatory business processes • Experience with validated GxP environments, including implementation, documentation, and change management • Hands-on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults (Required) • Broad technical knowledge, including hands-on experience designing and implementing system integrations, migrations, and SaaS in a regulated environment • Hands-on experience designing and building solutions with Java, Python, creating AI agents, and working with analytics tools including building Power BI reports • Proven track record of defining technology strategy aligned with business objectives • Previous experience as IT system owner supporting R&D • Experience in regulatory submission planning and tracking, registration management, commitment management, and content management • Knowledge of GCP, EMA and FDA regulations and other regulatory compliance standards • Experience with Agile, Waterfall, and Hybrid project management methodologies • Strong analysis and project management skills and attention to detail • Ability to challenge requirements with key stakeholders • Ability to solve highly complex enterprise-wide technical challenges • Ability to manage multiple activities, priorities, and deadlines • Excellent verbal and written communication skills • Ability to work in and appreciate a global diverse work environment • Ability to identify and communicate key issues in complex situations

🏖️ Benefits

• Remote flexibility • Competitive salaries • Inclusive environment

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