Overview
With oversight and guidance from the Senior Manager, Supply Planning, this role is responsible for ensuring continuous product supply in support of clinical trials. The individual will work with internal and external customers in order to accomplish clinical project objectives. The individual will develop packaging and supply plans and manage clinical supplies documentation requirements to support regulatory submissions. Responsible for monitoring inventory levels and executing resupply campaigns to ensure adequate supplies across regional depots. In addition, the individual will support supply chain initiatives and improvement activities.

EDUCATION AND QUALIFICATIONS

• 8+ years related experience in Supply Chain, Logistics, or Clinical Research with a Bachelor’s degree in Life Sciences, Logistics/Supply Chain or Business Administration; or 6 years related experience and a Master’s degree.
• 3+ years of relevant Clinical Supply Chain and/or Clinical Labeling experience.
• Strong knowledge and understanding of Pharmaceutical Supply Chain. Good Manufacturing/Distribution practice. Global clinical trials experience preferred.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience with IRT and/or ERP systems is a plus.
  The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

• Partner with Clinical Operations, Clinical Science and CRO to ascertain study start timelines and clinical demand forecast to inform supply planning and inventory management decisions.
• Create, review, and update the clinical supply plans based on strategic elements/study forecast from Clinical Operation and /or Medical Affairs
• Manage sourcing and clinical labeling campaigns of commercially sourced co-therapy drugs in support of global clinical trials.
• Work cross-functionally with Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Affairs, Logistics, and MSAT to ensure uninterrupted and compliant supply of study drug for clinical studies and programs.
• Manage the development and maintenance of Interactive Response Technology (IRT) and other systems used in managing inventory for clinical studies.
• Coordinate labeling, transportation, storage and distribution of clinical trial material for studies to be conducted globally where needed.
• Manage initiation and approval of label text and label proofs while developing a labeling strategy that is consistent with regulatory and study requirements.
• Review and update SOPs.
• Identify opportunities and implementation team for the continuous improvement of the Clinical Supply Chain processes.
• Work directly with all US and EU suppliers to ensure compliance of local and international GMP/regulation requirements and perform risk assessment to determine criticality.