Full-Stack Engineer

We are seeking a highly skilled Senior Full-Stack Engineer to join a strategic transformation initiative focused on accelerating SDTM (Study Data Tabulation Model) development through AI-enabled technologies.

This role will be responsible for designing, developing, and delivering a next-generation AI-powered application that enables automation, intelligence, and efficiency across clinical data transformation workflows.

The selected candidate will work closely with Development Systems, IT Engineering, AI Research Center, and Statistical Programming teams to build an innovative platform leveraging Generative AI, Large Language Models (LLMs), Machine Learning, cloud technologies, and modern application architectures., * Ensure stable, compliant, and high-performing Veeva Vault environments across all supported applications.

• Reduce recurring incidents through effective root cause analysis (RCA) and implementation of permanent corrective actions.
• Improve release quality, deployment readiness, and change management across all Vault environments.
• Strengthen integration reliability and data accuracy through proactive monitoring, validation, and issue prevention.
• Enhance system efficiency by optimizing workflows, configurations, and platform performance.
• Deliver accurate, actionable dashboards and reporting insights to support business and operational decision-making.
• Serve as the Technical Subject Matter Expert (SME), providing guidance, governance, and best practices to improve overall platform maturity.
• Innovation & Continuous Improvement:
• Establish and standardize reusable GenAI engineering patterns, frameworks, and best practices for scalable adoption.
• Continuously enhance AI capabilities based on user feedback, business needs, and emerging technologies.
• Drive automation and process improvements to increase operational efficiency and reduce manual effort.

Secondary Skills (Good to have):

• Veeva Vault Admin or Domain Specialist Certifications
• Exposure to SQL/XML/API debugging and data model understanding
• Experience coordinating with cross-functional global teams
• Familiarity with Life Sciences business processes across Clinical, Quality, or Commercial

Why This Role Matters -

This position is critical for Regulatory team Primary application team lead who can able to handle support activities such as PAC creation, Drive Platform release activities and help team in clarifying the queries with good understanding in Veeva Vault RIM (Submissions, Registrations, Content, SafetyDocs)

Why Join Us

• Understands enterprise software engineering practices
• Can operate effectively in a fast-paced innovation environment
• Has the ability to deliver high-quality solutions under aggressive timelines

This is a high-impact engineering role requiring deep technical expertise, strong product engineering mindset, and the ability to rapidly build scalable solutions in a highly complex and regulated Life Sciences environment.

Primary (Must have skills)

• Veeva Vault Certification(s) - Admin / RIM (preferred)
• 6-9 years of experience in Configure and manage Objects, fields, layouts, lifecycles, and object workflows, Document lifecycles, document types, classifications, and binder templates, Entry actions, validation rules, sharing settings, and security
• 6-9 years of strong experience in Design and implement cross-object relationships, constraints, and dependency logic. Manage picklist strategy, controlled vocabularies, and data standards.
• 4-6 years of Release & Change Management experience: Drive Release Impact Assessments (RIA) for Veeva General and Business releases. Lead change control activities including impact analysis, change proposals, risk assessments, and implementation plans.
• 4-6 years of Proven ability to handle complex incidents, root cause analysis (RCA), and L3-level triage
• 2-4 years of Experience in understanding of Vault data model, object relationships, and system limitations.
• 2-4 years of Expertise in data operations, including data quality checks, transformations, and migrations
• 4-6 years of Experience working within ITIL-driven Incident, Problem, and Change Management processes
• 2-4 years of Strong skills in building advanced Vault reports, dashboards, and analytical insights
• 4-6 years of Experience in working knowledge of GxP, validation requirements, and audit-readiness practices, * 10+ years overall experience, with 7+ years hands-on on Veeva Vault RIM (Submissions, Registrations, Content, SafetyDocs)
• Lead end-to-end Veeva Vault RIM implementations, upgrades, and general releases
• Own solution design for complex regulatory business requirements across Submissions, Registrations, and Content.
• Solid understanding of global regulatory processes (FDA, EMA, Health Authorities). Experience supporting regulatory submissions, commitments, correspondence, and archival processes.
• Proven experience in GxP validated systems and change control. Strong knowledge of CSV/CSA methodology.
• This role plays a critical part in ensuring platform stability, regulatory compliance, and successful delivery of Veeva Vault RIM capabilities.
• Provide technical governance, best practices, and architectural guidance for the RIM platform.
• Act as the primary escalation point (L3/platform support) for complex issues and system defect
• We are seeking an experienced Veeva Vault L3 Technical SME to lead advanced troubleshooting, release governance, integration operations, and compliance oversight for Vault applications across RIM. This role requires deep technical expertise, strong analytical skills, and the ability to collaborate with cross-functional stakeholders.

Soft skills/other skills:

Communication Skills:

• Communicate effectively with internal and customer stakeholders
• Communication approach: verbal, emails and instant messages
• Interpersonal Skills:
• Strong interpersonal skills to build and maintain productive relationships with team members
• Provide constructive feedback during code reviews and be open to receiving feedback on your own code.
• Problem-Solving and Analytical Thinking:
• Capability to troubleshoot and resolve issues efficiently.
• Analytical mindset
• Task / Work Updates:
• Priorior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
• Provides regular updates, proactive and due diligent to carry out responsibilities

About FalconSmartIT

We are a specialist IT Recruitment Agency. We specialise in finding the best IT professionals for your given IT requirement.

Falcon Smart LLC (US), Falcon Smart IT (UK), FS Talent Acquisition (India) set a mission to deliver value, service, transparency and quality service to all.

Headquartered in London,UK

We are Specialists at providing contract and permanent IT, Marketing, HR and Accountancy recruitment across the Globe, working with businesses of all sizes, from Small to Medium Enterprises (SMEs) to large international corporations.

Our industry and sector knowledge is second to none and whilst we utilise all of the key IT specific and leading generic job boards, nothing compares to our own carefully grown database and working knowledge of “whose who” in key industry sectors.