R&D and Regulatory Systems Lead

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $95k - $193k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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 and representative of cross-functional needs • Provide strong working knowledge of digital capabilities supporting global R&D business processes • Monitor emerging global health authority requirements and assess system impact • Develop and implement requirements to ensure compliance • Collaborate with business users to identify needs and translate them into functional and technical requirements • Perform requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis • Administer and develop Veeva RIM Vault, including package software, application implementation, and Vault API integrations • Lead administration, enhancements, fixes, configurations, and regular deployment of RIM Vaults • Lead technical design and enhance integrations between systems • Design, architect, and lead development of complex applications • Manage assigned projects through implementation within scope, schedule, and budget • Work globally on end-to-end R&D solution implementations and regulatory compliance • Drive compliance with IT Quality and Viatris SDLC, change management, and quality/testing processes • Collaborate with solutions leads and business partners to ensure technology meets business requirements • Support vendor relationships and escalate system issues

🎯 Requirements

• Bachelor's degree in science, IT, or a relatable field • 10 years’ of Regulatory business process knowledge and strong hands-on technical experiences configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions required • 10 years’ hands on experience with software design and development, system integrations, analytics report builds required • Prior experience in the pharmaceutical industry and a solid understanding of R&D & Regulatory business processes • Experience with validated GxP environments, including Implementation, documentation, and change management is necessary • 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 as well as working with 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 business processes for regulatory submission planning and tracking, registration management, commitment management and content management • Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards • Experience with project management methodologies such as Agile, Waterfall, and Hybrid approaches • Strong analysis and project management skills as well as attention to detail • Ability to challenge requirements with key stakeholders to ensure requirements are detailed and properly defined • Ability to solve highly complex enterprise-wide technical challenges • Ability to operate in a dynamic challenging environment and manage multiple activities, priorities, and deadlines. • Excellent verbal and written communication skills • Works well in and appreciates the value of a global diverse work environment. • Is able to see the larger picture and able to identify and successfully communicate key issues in complex situations. • Veeva RIM Vault certification preferred; Veeva certification desired • Advanced degrees are a plus

🏖️ Benefits

• Competitive salaries • Remote flexibility • Inclusive environment • Equal opportunity employment