For our international partner based in Basel/Kaiseraugst, we are looking for a qualified and motivated Clinical Materials Coordinator (m/f/d) 100% for a temporay contract of one year. With the possibility to extend. Latest possible start date is 1st of May 2021 !
The Clinical Materials Coordinator (CMC) leads the coordination and execution of all procurement activities of drug products and packaging materials for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production and delivery of Investigational Medical Products to our depots in accordance with international standards and regulatory requirements. Furthermore, the CMC is responsible for all tasks related to clinical demand planning of packaging material.
Tasks & Responsibilities:
Single point of contact for global clinical supply related procurements of drug products and packaging materials. This contains the following responsibilities:
Compile product-specific data and documents for drug products and packaging materials
Define, request and continuously update the master data of drug products and packaging materials in SAP-systems
Manage purchase orders for Roche development drug products, "Roche-Partner" drug products, Roche commercial drug products and external commercial drug products from internal and external suppliers in various systems
Plan and procure packaging materials in SAP-systems for the PTDS packaging site in Kaiseraugst and stability studies
Support the planning and procurement of packaging materials in SAP for the PTDS packaging site in SSF
Request the sampling and sample shipment of drug product and packaging materials
Initiate the system registration of packaging materials for QC testing
Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products and packaging materials
Request and continuously update GMP- and non-GMP-batch data of drug products and packaging materials in SAP
Ensure the QA-release or AFM ("Authorization for Further Manufacturing") of drug products and packaging materials on time
Manage drug products and packaging materials returned to Kaiseraugst
Manage the shelf-life extensions of packaging materials
Confirm the quantities received to enable accurate cost charging of drug products and packaging materials in the relevant financial systems
Actively support the cost allocation of drug products and packaging materials
Drive and lead the issue management for global clinical supply concerning the procurement of drug products and packaging materials as well as the goods receipt of drug product
Actively support GMP-, GCP- and BtM- (narcotic drugs) inspections
Actively support the Lean Production System (LPS)
Associate level of professional education or University degree preferably in Supply Chain Management and/or Healthcare Management
Work experience in supply chain, life science, industrial engineering or equivalent
High cultural awareness and social competence required as a cooperation and communication in complex situations with different cultures and countries (especially Northern American and Asian market) is part of the daily job
Demonstrated excellent problem solving and decision making skills
Experience with customer relationship management, ability to create trustful relationships with business partners
German and English written and spoken
Nice to Have:
Knowledge of SAP R3, APO knowledge is beneficial
Work experience in a GMP environment
Sound knowledge of Google and Windows office applications
Are you interested? Do not hesitate and submit your complete application documents online today.
We value diversity and therefore welcome all applications - regardless of gender, social origin, religion/belief, age or identity. We also process applications by post, but will not return them for administrative reasons.