Vera Therapeutics, Inc.

Biotech

ClinicalSupplyManager

€75–110k ~AI est. Bulgaria Remote Friendly
The Brief

“Clinical Supply Manager at Vera Therapeutics, Inc.. Skills: Clinical supply chain, Logistics, Manufacturing, Distribution, Inventory management. Define supply strategy for IMP. Represent Clinical Supply Chain on CST”

What You'll Achieve.

Ensure uninterrupted supply

Industry & Context.

Biotech

What They're Looking For.

Must Have

Bachelor's or Master's degree, 5+ years supply chain experience, Working knowledge of GMP, Working knowledge of GCP, Working knowledge of GDP, Ph3 Global study start up experience, Comparator Sourcing experience, Experience with IRT systems

What You'll Do.

Define supply strategy for IMP

Represent Clinical Supply Chain on CST

Provide service to internal stakeholders

Forecast IMP demand for global studies

Ensure on-time delivery of IMP

Maintain adequate inventory levels

Oversee label generation

Oversee label proofing

Oversee label translation

Oversee IMP shipments

Prepare import documentation

Prepare export documentation

Coordinate drug returns from site

Perform study drug reconciliation

Manage labeling/packaging vendors

Manage distribution vendors

Manage supporting service vendors

Manage comparator sourcing activities

Perform IRT user acceptance testing

Develop IRT supply strategy

Oversee ongoing IRT supply activities

Maintain audit readiness

Lead cross functional projects

Lead process improvements

Create process documents

Revise process documents

How You'll Work.

Team & Collaboration

Clinical Study Teams; Clinical Operations; Regulatory Affairs; Quality Assurance; CMC; Third-party packaging suppliers

Process & Methodology

Cross functional projects

Free ATS check

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