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Clinical Supply Planner, Crawley, West Sussex
Essential Pharma is seeking a Clinical Supply Planner to join our team. This role involves determining packaging and labeling requirements for clinical trial supplies, managing inventory of clinical trial supplies in line with clinical demand at sites, overseeing cold chain storage at local warehouses and clinical trial sites, and ensuring compliance with GCP and worldwide distribution regulations for export/import of study drugs. Strict adherence to national and international regulations, GMP standards, and GCP practices is essential throughout the supply chain.
Responsibilities
* Manage clinical demand and coordinate with manufacturing project management based on the clinical development plan.
* Collaborate with clinical managers to establish IMP needs per study protocol and territories.
* Work with the Development Project Manager to forecast clinical demand and coordinate the delivery of supplies.
* Drive project schedules and deliverables, liaising with internal and external stakeholders.
* Coordinate labeling, packaging, and distribution to prevent stock outs.
* Serve as the primary contact for project challenges related to clinical supplies.
* Ensure timely project delivery and proper documentation according to GCP and TMF standards.
* Maintain inventory of IMP and oversee transfers and shipments.
* Develop and implement SOPs related to clinical demand and distribution.
* Establish communication pathways and risk assessments to ensure a robust supply chain.
* Coordinate with third parties such as CROs and consultants.
* Oversee the setup and maintenance of the IRT system.
* Monitor inventory levels, troubleshoot issues, and manage project risks.
* Monitor budgets and quality issues, and manage temperature excursions during transit.
Qualifications
* Experience in pharmaceutical supply chain, especially with clinical trials across multiple territories and sites.
* Knowledge of GXP, GCP, GMP, and related documentation.
* Experience with ERP systems and stakeholder management.
About Us
Essential Pharma is an international specialty pharmaceutical company focused on niche medicines for small patient populations, with a portfolio covering CNS, gastroenterology, ophthalmology, and rare diseases, operating in over 70 countries.
What We Offer
* Flexible hybrid working environment.
* Home office allowance, pension scheme, life insurance, enhanced leave and sick pay, annual leave, and performance bonuses.
Our Values
We promote an inclusive, agile, and responsible culture that values autonomy, social connection, and employee growth, fostering a collaborative and respectful workplace environment.
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