Sr Clinical Supply Chain Analyst

Clinical Supply Chain Analyst

Responsibilities: Clinical Supply Chain Analyst will be responsible for supporting the on-time delivery of clinical supplies. This role will be responsible for supporting Clinical Supply Chain by contributing to various work streams with key service providers and supporting special projects/continuous improvement initiatives as required. Work closely with Clinical Drug Supply Manager and Master Planner in the review, interpretation, and implementation of supply forecast plans. Create/support shipments for products, intermediates, and WIP to the appropriate sites. Support creation of shipment documents, e.g. invoices for import or export, End-Use Letters, USDA Letters, import applications, and permits. Support investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation, and obtaining approval to ship. Proactively identify risks, develop, implement, and communicate mitigation strategies. Develop and review SOPs and processes, guidelines for compliance with global regulatory requirements. Perform closeout activities and at the vendors including drug accountability, reconciliation, destruction processing, and file archiving. Support the clinical product label development process which includes the creation of master label text, translations, and label proofs. Track shipment issues (damage, temperature excursions, non-compliance, etc.) and work to resolve recurring problems with permanent solutions. Execute appropriate inventory movement transactions within the ERP system. Maintain up to date information regarding initiatives by FDA, EMA, and other applicable regulatory authorities relating to clinical supply and documentation. Perform other duties as required.

Qualifications: Bachelor's degree or equivalent is required. 2+ years of experience working in a Biotech or Pharmaceutical industry in Clinical Supply Management. Solid understanding and working knowledge in import, export, IOR, invoice proforma, and other documentation required to enable distribution. Prior experience in Clinical Supply Chain Management and ability to work cross-functionally with Clinical Operations, CMC, Quality, and CMOs, to ensure seamless execution. Experience interacting with and managing third-party operations like vendors, CMOs, and logistics providers. Solid understanding and working knowledge in cGMP, GCP and other applicable international regulations/guidelines (e.g. EU, Asia-Client, etc.)