Senior Associate SP&L

Job Summary

This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control, and departmental collaborations. Work is escalated if outside scope of role and/or complexity. The position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirements, but may seek support on such items from time to time.

Knowledge of identifying critical issues or problems with projects and recognising risks that may compromise patient dosing or safety is required. A basic understanding of professional working environment, quality assurance, global regulatory requirements, CAPAs, deviations, import/export requirements, and IRT systems for forecasting and planning of drug supply needs is essential. Ability to participate effectively on cross‑functional and global teams is required.

• Works, under supervision, with outsourcing to submit appropriate requirements on a project basis.
• Supports the team in generating RFPs, reviewing proposals, and selecting vendors.
• Supports the management of the work order development and implementation.
• Supports packaging design and patient kit supply preparation, label generation and approvals, and associated interactions with vendors.
• Supports regular vendor/sponsor discussions to identify risks and ongoing study support.
• Identifies critical issues that may compromise patient dosing or safety.
• Supports comparator sourcing requirements and RFP generation, working with outsourcing to submit appropriate requirements on a project basis.
• Manages vendor interactions on packaging design and patient kit supply preparation, label generation and approvals.
• Ensures on‑time site shipments for subjects and patient dosing, and ensures that material is fully released prior to shipment to site.
• Ensures compliance with all domestic and foreign regulatory requirements, seeking line management support when necessary.
• Possesses basic knowledge of import/export requirements, recognizing potential global issues such as import license requirements and shipment delays, and can communicate issues and support resolution development.
• Supports IRT design for control of drug dispensing and inventory management.
• Understands user specifications in support of IRT processes and basic concepts of IRT.

• Education Qualifications
  :
  Bachelor's Degree in Pharmacy or related field preferred;
  PharmD preferred;
  Master’s Degree preferred.
• Experience Qualifications
  : 4 or more years of related experience preferred.
• Experience in Project Management, Clinical Supply Management, and/or Clinical Trials Coordination required.
• Demonstrated experience in inventory management, forecasting, and distribution of drug supply needs.
• IXRS experience and managing vendors.
• Contributing to budget control preferred.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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