Our client is a world leader in providing drug development and manufacturing, clinical trial, and packaging technology services to the pharmaceutical industry.
Currently, they require a driven individual to join their high-performing Project Management team.
The Associate Project Manager (Labelling and Distribution) supports customer (clinical) projects to ensure that project goals and objectives are accomplished within the appropriate time frames, budget, and in accordance with customer expectations and pharmaceutical regulatory requirements.
The Successful Candidate will manage and play an integral part in strategic customer relationships - Our client is known for providing an industry leading customer experience.
Along with the above, the Associate PM will be responsible for the management and set up of distribution processes and critical materials for their assigned projects - This will involve providing materials quotes for the specific project, preparing MBRs, finished product specifications, preparing Logistics Management Documents, template packaging slips, template commercial invoices, specifying and ordering critical materials to be procured for the project, assisting with developing GMP agreements, supporting permit applications and ensuring that third party vendors (couriers, IxRS, destruction, etc.) are set-up and coordinating the production and distribution activities to deliver outcomes in line with the agreements.
We are seeing applications from individuals with up to 3 years experience in a similar role.
Candidates that have worked in a similar role within the contract manufacturing pharmaceutical space will be highly regarded.
Essential skills and experience:
- Tertiary qualification - Science, Pharmaceutical Sciences (additional business orientated qualification highly regarded)
- At least 3 years related experience - Pharmaceutical industry highly regarded
- Excellent mathematical skills
- Advanced computer skills - Ability to perform the most complex computer tasks and operate various computer programs
- Excellent communication skills - Both written and verbal | Strong ability to connect and communicate with staff from all areas of the business
- High attention to detail and strong ability to prioritise and organise workload
- A positive can-do attitude
Primary responsibilities of this role:
- Involved in the overall project management for assigned projects/ customers using appropriate project planning tools for assisting the Project Management team. Supports the project start-up, set-up and project tracking in order to communicate milestones, critical path activities to ensure the project achieves all deliverables per the customer requirements and agreed upon timelines
- Secondary (back-up) customer contact for clinical packaging and/or distribution activities and relationship management with the customer project teams for assigned projects/customers
- Provide support to business development and estimation regarding new quotations and resupplies
- Sound understanding of clinical trials and supplies
- Provides continuous support to Project Managers and production/warehouse/logistics team by being the daily point contact for day-to-day internal problem solving and trouble shooting
- Assists to create minutes/agendas for customer calls as required
- Creates project specific documentation including master batch records, finished product specifications, printing and issuance form requests, bill of materials spreadsheets, logistics management documents, template packing slips, template commercial invoices, inventory requests, returns and destruction related documentation and supporting documentation for permit applications
- Communicates internally to resolve missing or erroneous certificates and documentation related to receiving and QC release of bulk, packaging components and shipping supplies
- Monitors and updates production scheduling and shipment requirements to support the project needs
- Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests
- Works with Project Managers/customers and sites to resolve discrepancies on end of study returns
- Coordinates the creation of Inventory Disposition Reports and forwards to customers for destruction approval of returns, remaining finished goods and customer owned inventories.
- Processes and records data in project specific metrics
- Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage & distribution for assigned projects. Acts as back up Project Manager contact for internal communications and trouble shooting
- Training and on-boarding of new employees within same role as requested
- Maintains and updates project plans and timelines as requested
- Knowledge of adherence to all company, cGMP, and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects
- Performs any other tasks or duties as assigned by the Manager/Supervisor
If your skills and experience match the above criteria, then please apply with your covering letter and resume in Word Format.
Questions can be directed to Leah Creswick at Fuse Recruitment on 0478 193 170.