MNC Pharmaceutical company is looking for Project Leader.
- Hold full responsibility for the timely delivery of projects through successful coordination of all tasks associated with packaging, labelling, distribution and drug supply management.
- Assume the role of Global Project Leader for projects involving multiple their facilities, working in accordance with the Service Level Agreement. Work directly with the Project Managers at the other facilities.
- Generate project plans for submission with quotes to assist Business Development (BD) in communicating project timelines, ahead of work being awarded to them.
- Determine scope and operational requirements of the project from the quotation and customer supplied information. Align customer requirements to their internal processes, where possible.
- Notify BD of any additional requests for services that have not been included in the quotation or changes to project scope.
- Ensure a valid Technical Agreement (TA) is in place with each customer to document standard working practices and define responsibilities between this client and the customer. Implement a TA with every new customer, liaising with all relevant departments to ensure customer and their requirements are covered. Ensure TAs are revised within their review dates and/or updated as changes are needed.
- Ensure the appropriate Production and Distribution project management resource is assigned to the project by liaising with the Project Group Managers at each facility involved.
- Lead the activities of the project team at all stages of the project, coordinating tasks and ensuring completion in line with the timelines agreed on the project plan.
- Disseminate all information from the customer accurately and promptly to all relevant internal stakeholders, ensuring any actions are understood and agreed with the project team as appropriate.
- Work with the their Supply Chain Manager on applicable projects to implement the packaging and distribution strategy devised for the project.
- Create a project plan for each project at initiation in consultation with the project team. Identify and include on the plan all critical tasks and inter–dependencies impacting project timelines, including tasks being performed by other facilities and/or their divisions.
- Update the project plan to always reflect the current status of the tasks associated with the project.
- Provide project plan to customer at project initiation and then regularly throughout the project to communicate timelines, responsibilities for tasks and project status.
- Hold a kick off meeting with the their project team at project initiation to ensure information is provided so that all team members are fully aware of the scope of the project and their responsibilities within the team.
- Hold a kick off meeting with the customer at project initiation to ensure agreement is met on the scope of the project and their project management responsibilities. A review of the project plan and an introduction of the project team will also be part of this meeting.
- Set up and approve protocol and site details on COSMOS (ERP system) for each new project in line with procedure.
- Request set up of project folders in their document management system at project initiation in line with procedure.
- When assigned, assume the role of Lead their Contact for projects involving Clinical Technologies, working in accordance with the Service Level Agreement.
- Coordinate the activities of other their business units involved in the project, such as their Sciences or their Pharma Services, where applicable, ensuring that customer expectations are understood by all parties. Include key deliverables on the project plan.
- Work with third parties involved in projects, such as IRT providers, CROs or consultants at project initiation to determine and clearly define their responsibilities within the scope of the project.
- Liaise internally with other departments, departmental managers and business units as required, to control the project, resolve problems and escalate issues.
- Perform risk assessments at project initiation and continually assess throughout the project. Work together with project team and customer to prioritize and mitigate any project risks identified.
- Log all billable project management time in the timesheet system, PTR. Monitor actual hours logged for the global project team against the estimate in the quotation and inform BD as actual hours logged approaches the estimate (i.e. at 50%, 75%, etc.). Assist BD with customer invoice queries on PM hours.
- Assist with customer budget management.
- Generate Project Management Documents (PMD) for all applicable projects, in accordance with procedure, ensuring information is clear and unambiguous. Highlight any critical project requirements contained within the PMD to the team.
- Develop and maintain project related documentation to a high standard in accordance with procedure. Generate agenda, minutes/ actions as applicable for internal and customer project meetings.
- Work with the customer to determine requirements for close out / protocol reconciliation reports that may be required at project completion to ensure the necessary information is captured throughout the project life cycle. Work with IRT group to agree reporting format if applicable. Ensure protocol set up and design accounts for any specific project close out/drug reconciliation requirements.
- Notify Project Close-Out Specialists when a project is complete to permit the commencement of close out activities. Coordinate the collation of any customer specific close-out reports.
- Review Quality Incident (QI) and Technical Query (TQ) reports for customer at all facilities. Ensure any trends in quality issues reported are identified and actioned accordingly.
- Generate/ import Medication Number Lists on COSMOS in line with procedure.
- Generate their Gateway user account requests for customers in line with procedure.
- Have high level oversight and understanding of critical project documentation (e.g. master labelling templates, label proofs, IRT URS, Drug Shipment Details, Distribution Instructions, Depot Project Instructions, Packaging Specifications).
- More than 5 years of relevant technical experience to have maturity to drive projects and lead discussions
- Fluent in English and Japanese to liaise with clients
- Experience within a pharmaceutical, CRO, production, logistics or quality environment
We regret to inform applicants that only shortlisted candidates will be notified.
Thank you for your understanding.
JAC Recruitment Pte. Ltd.
EA Licence No: 90C3026
EA Personnel: R1984018
EA Personnel Name: SENA YAMADA