A leading biopharmaceutical company that specialises in quality and process manufacturing management is seeking to recruit a Clinical Supply Project Associate to their office in Leicester. This organisation specialises in sourcing, distributing, and managing comparator drugs and other pharmaceutical products and supplies for clinical trials, including biosimilar trials and research. This is an exciting opportunity to work with an internationally renowned leader in the biopharmaceutical field.
The Clinical Supply Project Associate will work closely with their Project Manager, providing support across the full range of project management activities, including the coordination, procurement, and labeling (if required) of drug product supply and distribution activities in accordance with supply chain requirements. The Project Associate will work directly with external customers, internal departments, and suppliers to develop and communicate protocol labeling and distribution documents, timelines, and processes that deliver a seamless and high-quality project experience.
Job Responsibilities:
- Working with clients to determine clinical trial drug requirements and developing appropriate supply strategies, project timelines, and project plans to meet the Clients study requirements.
- Interfacing with appropriate external customers to successfully deliver the Client's product requirements in a timely and cost-effective manner.
- Coordinating with the Client and Project Manager to define requirements (documents, drug products, forms and/or labeling, if required). This includes creating protocol specific Label Proofs, Batch Records, Distribution Instructions, Drug Shipment Request templates, and other study documentation, as appropriate.
- Coordinating with internal departments to ensure that activities are performed in accordance with Client expectations, appropriate industry regulations (EMEA/Home Office/FDA), and industry accepted quality standards.
- Supporting both internal and outsourced packaging and labeling activities, including project setup, communication of Client requirements, sourcing of labels, and other packaging supplies as needed.
- Managing the material flow and coordinating batch record review and release.
- Participating in GMP labeling and distribution activities based on workload and resource availability. Activities will occur in both the ambient and 2-8°C environment.
- Monitoring the overall Client product inventory, ensuring appropriate supplies are ordered, labelled, maintained, and distributed to clinical sites, based on industry standards and specific Client project requirements.
- Receiving and processing clinical site drug shipment requests received for shipments to clinical sites.
- Monitoring shipments to clinical sites, e.g. courier tracking, acknowledgement of receipt, cold chain product management (temperature excursions), etc.
Skills and Requirements:
- A university degree in science, pharmaceutics, natural sciences, or other relevant area is desirable.
- A minimum of 1 year of relevant project experience in a pharmaceutical contract service organization, such as Contract Packaging/Labeling, Drug Procurement, or Clinical Distribution is required.
- An understanding of GMP procedures, regulations and a working knowledge of IWRS is desirable.
- Excellent numerical competence in order to analyze facts and figures.
- Ability to make well-reasoned recommendations and to cope with the pressure of demanding targets and tight deadlines.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joseph Corderoy at +44 203 854 0629 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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