AdresThe Associate Clinical Supply Chain is responsible for managing the clinical study setup process within a regulated Supply Chain environment, including GMP, GDocP, and GDP compliance. This role collaborates with project managers in the Clinical Supply Chain to lead the global design and setup of Clinical Supply Chains for assigned clinical programs efficiently and effectively.Responsibilities:
- Contribute to achieving milestones related to the setup of global Supply Chains for clinical trials.
- Provide support to the Global Setup Lead team by executing various tasks.
- Manage Master Data in ERP (SAP) and ensure ERP readiness.
- Initiate requests for clinical label materials and Finished Drug Product Materials.
- Request Bill of Materials (BOM) and Work Breakdown Structure (WBS) elements.
- Coordinate the setup of Study Design Tables.
- Prioritize and coordinate the artwork creation process, including resolving issues and following up on queries.
- Create and maintain Product Specification Files throughout the clinical trial life cycle.
- Manage third-party depot plans and cross docks to support global study footprints.
- Maintain metrics for the Global Setup Lead team.
- Contribute to the monthly workforce planning cycle.
Requirements:
Minimum Requirements:
- Bachelor's degree or equivalent in logistics, business administration, or life science.
- Relevant working experience, preferably in the biotechnology or pharmaceutical industry.
- Experience in an international and regulated environment.
- Understanding of logistics/Supply Chain principles, especially Bill of Materials (BOM).
- Experience in planning and project management techniques.
- Advanced proficiency in MS Office applications (Word, Excel).
- Fluency in English, both in oral and written communication.
- High-quality work standards and ability to set priorities with timely escalation.
Preferred Requirements:
- Knowledge of Clinical Supply Chain management.
- General understanding of regulatory guidelines impacting clinical supplies, such as GxP and International Conference on Harmonization (ICH) guidelines.
- Experience in using SAP.
- Excellent communication and issue resolution skills.
Salary Benefits:
- A challenging work environment with excellent career development programs.
- You have the opportunity to grow within the company and to fully develop your skills and competences.
- Hybrid position, once or twice per week on site in Breda.
- For this role, the company offers a competitive salary package.
- Reimbursement of travel expenses is dependable on travel distance.
- The contract will be through Undutchables
Our client is an international market leader in the pharmaceutical industry – focused on transforming science and biotechnology into therapies that have the power to restore health or save lives. The patients are the main priority at all times. This USA founded organization holds a large site in Breda, where produced medicines are labeled, stored and shipped worldwide, to more than 75 countries. The staff in Breda works on Supply Chain processes, engineering, clinical research, marketing and sales on a daily basis. The company culture is dynamic and fast paced, with a strong international character.
