Biocon
Website:
biocon.com
Job details:
Job Responsibility
1. Regulatory Systems Implementation & Management
Lead implementation and lifecycle management of Regulatory Information Management Systems (RIMS), eCTD publishing tools, and submission platforms (e.g., Veeva Systems, Oracle Corporation Argus Safety).
2. Clinical Systems Oversight
Manage deployment and upgrades of Clinical Trial Management Systems (CTMS), EDC, and eTMF platforms aligned with clinical development goals.
3. Compliance & Validation (CSV/CSA)
Ensure IT systems comply with U.S. Food and Drug Administration 21 CFR Part 11, GxP, Annex 11, and global regulatory standards through proper validation and documentation.
4. Pharmacovigilance & Safety Systems
Oversee safety databases, signal detection tools, and integration with global safety reporting systems.
5. Stakeholder Engagement & Business Alignment
Partner with Regulatory, Clinical, Medical Affairs, Quality, and PV teams to align IT initiatives with strategic business objectives.
6. Project Governance & Portfolio Management
Establish governance frameworks, manage project charters, budgets, timelines, KPIs, and executive reporting.
7. Vendor & Third-Party Management
Manage relationships with technology vendors, CROs, and SaaS providers, including SLAs, performance metrics, and contract compliance.
8. Data Integrity & Governance
Ensure ALCOA+ principles, master data governance, metadata standards, and audit readiness across regulated systems.
9. System Integration & Interoperability
Oversee integrations between CTMS, EDC, RIMS, Safety, ERP, and document management systems.
10. Inspection & Audit Readiness Support
Support regulatory inspections (e.g., FDA, EMA) by ensuring validated systems, audit trails, and documentation readiness.
11. Risk Management & Issue Resolution
Proactively identify, assess, and mitigate project and compliance risks using structured risk management frameworks.
12. Budget & Resource Management
Develop and manage annual IT budgets, resource allocation, forecasting, and cost optimization initiatives.
13. Change Management & User Adoption
Lead organizational change management, user training, communication plans, and adoption strategies for new systems.
14. Innovation & Digital Transformation
Drive automation, AI-enabled analytics, cloud transformation, and digital solutions supporting regulatory intelligence and clinical operations.
15. Cybersecurity & Data Privacy Compliance
Ensure systems comply with global privacy regulations (GDPR, HIPAA) and corporate cybersecurity standards to protect sensitive clinical and patient data.
• Experience Required: 6–10 years in Life science IT
• Qualification: B.Tech
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