Internal Job Title: Engineer I, Packaging/Labeling
Manages and co-ordinates all technical and service aspects of a project. This will range from initial discussions with clients, development of the project specifications, documentation aspects of setting up the project and management of all project related activities through to project/study completion.
1. Assessment of clinical protocol and other client supplied study specifications in conjunction with Proposals Group, FACTS Technical Group, Clinical Supplies, Operations and Procurement to help design Supply Chain solutions to meet the needs of the trial. Provision of data and technical input to the Proposals group to help them in the creation of proposals.
2. Working with the internal stakeholders and or client to finalize logistics requirements. This may include Project meetings at the client site or at Fisher.
3. Coordination and communication of all relevant activities, both internal and external to ensure that all services and products are ready for the start of the study or as required by the client.
4. Overall responsibility for ensuring that activities come together in a timely manner to meet the client and study requirements.
5. Timely provision of reports and other information to clients and internal team.
6. Organization and delivery of training, including cross training of other members of Fisher where appropriate.
7. Provide input into the writing and review of departmental SOP’s.
8. Participation in client meetings / bid support meetings / teleconferences, where appropriate.
9. Writing of documentation for the control of packaging operations
10. Work with Scheduling to optimize the production of clinical supplies – balancing the client requirements with best use of available production capacity
11. Support direct supervisor to oversee day to day packaging operation team to ensure all processes are compliant to quality and SOP standard.
12. Manages the ordering, replenishment and delivery of packaging materials.
13. Working closely and support procurement department to formulate and meeting purchasing needs.
14. Working closely with finance and client service department to support monthly invoicing.
15. Has no authority in making any financial decision.
Education: College Degree or equivalent
Years of Experience:
1. Relevant experience of clinical trial and clinical trial packaging, preferably to include handling complex protocols, key clients and business objectives.
2. Understanding of logistical countries requirements.
3. Flexible and adaptable with strong customer management skills.
4. Able to analyze problems and define solutions.
5. Able to work under pressure and to support others within team.
6. The post holder needs to have good organizational, verbal, written and numerical skills
1. Interpersonal skills/Communication
2. Driving for success
3. Analytical Decision Making
4. Customer Focus
5. Managing and Initiating Change
7. Ability to deliver accurate and precise information to clients and internal team.
1. Operations, Quality Assurance, Finance, Sales, Business Planning, Distribution Project Managers
2. External Fisher sites
1. Extensive client contact
2. Providers of other services associated with projects
1. Bachelor Degree
2. >5 years relevant work experiences gained in supply chain, ideally in clinical trial and clinical trial packaging.
3. Has experience in managing a team of employees
4. Leadership, excellent skill in both written and oral English