External Packaging Coordinator (Pharmaceutical)

This is a contracted position through Red Eagle Recruitment (AGY) To apply please up load an up to date CV in a MS WORD Format.

********THIS IS A PROJECT MANAGEMENT POSITION******************

• Work with the SCL to review and interpret the clinical protocol to develop practical and efficient packaging designs for Clinical Supplies. Partner with the SCL to generate and approve the Clinical Packaging Request.
• Partner with the SCL and other work-streams to generate and approve the Clinical Label Request.
• Work with the SCL to ensure the Packaging Diagram contains sufficient detail regarding the packaging to be completed.
• Assess packaging requirements and procure specific materials to meet study needs, approve tooling and card designs.
• Using modules within the Current Approved Inventory Management system, design kit structures, model protocols, design labels, monitor and track the approval of country panels and generate packaging requests to enable the fulfilment 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 for importing packaged inventory for distribution purposes.
• Fully utilising scheduling tools to proactively identify soft demand job assignments; work with the SCL to determine hard demand submission of the Clinical Request.
• Update scheduling tools with the progress of work and immediately raise issues with the SCL and local schedulers that may result in failure to meet timelines. Work with CSP Group Lead, local scheduler and enabling work-streams to remediate/prioritize.
• Work with Inventory Management, Quality Assurance and Global Analytics to co-ordinate and drive the progress of the packaging operation to ensure timelines are met.
• Manage multiple projects working with colleague Packaging Coordinators and master planner to resolve external packaging operation schedule conflicts and issues.
• Utilise the cost estimating tools for external operations to provide quotations for budgetary purposes; compare quotations received from vendors to the cost estimating tool and raise any significant discrepancies to line management.
• Approve quotes for contract packaging and/or labelling
• Communicate the study packaging and/or labelling requirements to the contract packaging/labelling organizations.
• Complete Clinicopia functions; generate/prepare study documentation and where appropriate, carry out a final review of packaging documentation before submission to QA.
• Utilize Project Management skills to plan, schedule and assess risks to complete the job.
• Keep current with all Good Manufacturing Practice training.
• Review contractor packaging and labelling documents making recommendations where appropriate to ensure compliance with Clinical Supply Packaging procedures, study requirements and Good Manufacturing Practice.
• Develop strong relationships with global contract packaging organisations.
• Coordinate multiple packaging and labelling operations at various global contract packaging organizations.
• Support oversight visits to contract organisations to ensure contractor compliance with Global outsourcing procedures.

Person Specification

Essential Attributes Desirable Attributes Education

• Life Sciences degree or equivalent. • Life Sciences MSc. or equivalent.
Experience •

5+ years experience in a clinical supply chain.
• Working knowledge of packaging clinical supplies to minimise time and cost while maintaining quality.

• Extensive knowledge of clinical trial designs, packaging technologies and GMP documentation.
• 3 years + of demonstrated contractor management or work experience within a packaging team at an external contractor.
• Knowledge of both packaging and the interactions with materials management.
Technical Ability
• Proficient in using information systems.
• Excellent planning, prioritisation and organisational skills.
• Articulate in both verbal and written communication.
• Solid understanding of project management concepts and skills.
• Routinely manages multiple projects working with various project teams.
• Proven ability to negotiate and problem-solve.
• Management of deadline driven projects.
• Recognised as a SME with significant project contribution.
• Demonstrates strong understanding of the different types of packaging operations and facilities.
• Working knowledge of functions outside of the supply chain.

• Able to solve project scheduling conflicts and maintain on-time delivery to the customer.Enjoys interacting with different teams to deliver multiple projects at the same time.Holds themselves accountable to deliver quality documentation to various groups. Enjoys meeting and developing relationships with new people.Proven ability to work within a changing environment.

Ability to facilitate cooperation with other departments.
• Can identify and implement new processes.
• Demonstrates good management, planning and decision making skills.

Personal Characteristics

• Self-starting independent thinker.
• Excellent communication and listening skills.
• Customer focused.
• Team player yet able to think and work independently.
• Proven interpersonal, facilitation, customer relations and negotiation skills. • Open to new ideas and recognises new opportunities.
• Contributes to global projects, identifying obstacles and priorities.