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Job

Clinical Packaging Coordinator

ROLE SUMMARY

Clinical Supply Packaging (CSP) is part of the Medicinal Sciences Global Clinical Supply (GCS) Group. Our purpose is to provide packaging solutions based upon a commitment to reliability, trust, confidence and ease of customer interaction to deliver quality packaged clinical supplies to the patient.

The External Vendor Packaging Coordinator (EVPC) interfaces globally with Supply Chain Leads (SCL), and all other groups within or outside supply chain to bring a packaging request to completion. The EVPC acts as a Project Manager to ensure that these activities are performed at third party locations within agreed to timelines and meeting the initial request parameters

Position requires project management, supply chain management, communication and collaboration skills.

Role Responsibilities:

  • Provide Clinical Packaging expertise to our stakeholders and utilize Project Management skills to plan, schedule and assess risks to complete the packaging operation.
  • Coordinate and communicate multiple study packaging and/or labeling requirements across a network of global packaging vendors.
  • Work with the Supply Chain Lead (SCL) to review and interpret the clinical protocol to develop practical and efficient packaging designs for Clinical Supplies.
  • Fully utilize scheduling tools to proactively identify job assignments; work with the SCL to determine submission of the Clinical Request.
  • Generate and author key Good Manufacturing Practice (GMP) documents, which include the Clinical Packaging Request (CPR), the Packaging Diagram (PD) and the Clinical label Request (CLR).
  • Using modules within the Current Approved Inventory Management system to generate packaging requests to enable the fulfillment of packaging operations, such that packaged materials can be shipped or transferred for distribution to clinical sites or depot holding areas.
  • Facilitate the use of Clinical Supply Distribution System (CSDS) for importing packaged inventory for distribution purposes.
  • Update scheduling tools with the progress of work and immediately raise issues with the SCL and local scheduler that may result in failure to meet timelines. Work with line management, local scheduler and enabling work-streams to remediate/prioritize.
  • Review contractor packaging and labelling documents making recommendations where appropriate to ensure compliance with Clinical Supply Packaging procedures, study requirements and Good Manufacturing Practice.
  • Carry out the review of packaging documentation before submission to Quality Assurance for release.
  • Work with Inventory Management, Quality Assurance and Global Analytical to co-ordinate and drive the progress of the packaging operation to ensure timelines are met.
  • Be compliant with current GMPs when ensuring the delivery of clinical supplies.
  • Support internal/vendor investigations and deviations in partnership with Quality Assurance.

BASIC QUALIFICATIONS

  • Life Sciences degree within a scientific discipline or 2-3 years equivalent experience in Supply Chain.
  • Demonstrated project management skills.
  • Experience working in a GxP regulated work environment.
  • Strong planning, prioritization and organizational skills.
  • Articulate in both verbal and written communication.
  • Excellent customer focused communication and listening skills.
  • Strong interpersonal, facilitation, customer relations and negotiation skills.
  • Proficiency in Microsoft Office and enterprise wide applications or systems (e.g. Clinicopia, CSDS, GDMS)

ADVANCED QUALIFICATIONS

  • Life Sciences degree within a scientific discipline with 5+ years of experience in Supply Chain.
  • Knowledge of clinical trial study designs and GMP documentation.
  • PMP certification or demonstrated project management experience
  • Excellent planning, prioritization and organizational skills.
  • Articulate in both verbal and written communication.
  • Excellent customer focused communication and listening skills.
  • Proven interpersonal, facilitation, customer relations and negotiation skills.
  • Proficiency in Microsoft Office and enterprise wide applications or systems (e.g. Clinicopia, CSDS, GDMS)

This position will primarily interface with the following:

  • Third party packaging and labeling contract vendors
  • Global Clinical Supply (GCS) - Supply Chain Leads, Distribution, Import/Export, IRT Global Oversight Team
  • Quality Assurance, Regulatory Affairs (CMC), Analytical Development

Monroe Staffing Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, color, Religion, gender, disability, veteran status, sexual orientation, gender identity, national origin or other protected classification.