Posted:1 day ago|
Platform:
Work from Office
Full Time
Program & Delivery Leadership: Ability to manage large, multi-region, multi-technology implementation programs with structured governance.
• Regulatory Domain Expertise: Strong functional knowledge of RIMS, eCTD submissions, Labeling, Artwork, and regulatory operations.
• Technical Implementation Experience: Hands-on familiarity with Veeva Vault, CARA, ECM platforms, upgrades, re-engineering, and data migrations.
• Compliance & Validation: Expertise with ERES, ANNEX 11, 21 CFR Part 11, and validated system documentation.
• SOW & Financial Governance: Strong command of estimations, ROMs, SOW creation, pricing models, vendor oversight, and profitability management.
• Cross-Functional Influence: Ability to collaborate with Product, Engineering, Sales, and SMEs to align delivery with strategic objectives. • Risk & Escalation Management: Proactively identify risks, maintain mitigation plans, and engage leadership at the right time.
• Team Leadership: Experience managing global teams and scaling capabilities in high-complexity environments
Knack Consulting
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