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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and R&D processes, with a strong focus on Veeva RIM Vault administration, system integrations, and compliance with FDA and EMA regulations. Proven ability to manage projects effectively while collaborating with diverse teams to translate business needs into technical solutions.
Highest-signal resume keywords
Veeva RIM Vault AdministrationRegulatory Business Process KnowledgeSystem IntegrationsProject ManagementGxP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
JavaPythonVeeva Vault ConfigurationAnalytics Report BuildsProcess ModelingRoot Cause AnalysisData FlowsChange ManagementAgile MethodologyWaterfall Methodology
Soft Skills
Excellent Communication SkillsAttention to DetailStakeholder ManagementProblem-SolvingAbility to Manage Multiple Priorities
Tools & Technologies
Veeva Vault RIM PlatformPower BISaaS SolutionsIT Quality SystemsRegulatory Submission Tools
Industry Keywords
Pharmaceutical IndustryRegulatory ComplianceGCPEMA RegulationsFDA Regulations
Tech Stack
Tools & technologiesGoogle Cloud PlatformJavaPythonSDLCVault
About the role
Key responsibilities & impact- Work with Regulatory Affairs and 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
- Develop and implement requirements to ensure compliance
- Collaborate with business users to identify needs and translate them into functional and technical requirements
- Gather requirements using process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis
- Administer and develop Veeva RIM Vaults, including package software, application implementation, and Vault API integrations
- Lead RIM Vault administration, enhancements, fixes, configurations, and code migrations
- Provide technical design for projects and improve system integrations
- Manage projects through implementation, ensuring delivery within scope, schedule, and budget
- Work globally with IT teams to implement R&D solutions and ensure FDA, EMA, and other health-agency compliance
- Drive compliance with IT Quality and Viatris SDLC processes, change management, and testing procedures
- Collaborate with solutions leads and business partners to ensure technologies meet business requirements
- Support vendor relationships and escalate system issues promptly
- Own and support R&D IT systems
Requirements
What you’ll need- Bachelor's degree in science, IT, or a relatable field
- 7 years’ of Regulatory business process knowledge and strong hands-on technical experiences configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions
- 5 years’ hands-on experience with software design and development, system integrations, analytics report builds
- 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
- Hands-on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults
- Broad technical knowledge, including system integrations, migrations, and SaaS in a regulated environment
- Hands-on experience with Java, Python, creating AI agents, and analytics tools including Power BI reports
- 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 and define requirements with key stakeholders
- Ability to manage multiple activities, priorities, and deadlines
- Excellent verbal and written communication skills
- Ability to work effectively in a global diverse work environment
- Ability to identify and communicate key issues in complex situations
Benefits
Comp & perks- Competitive salaries
- Benefits
- Remote flexibility
- Inclusive environment