Trial Product Handling Specialist
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Do you have a desire to set direction for processes around Trial Product Handling at clinical sites globally which is essential for the ’s clinical trials? Are you eager to learn about how develops and run Clinical Trials? If your answer is yes, then we have the perfect opportunity for you! The Position The position is in the department Supply Chain Planning. You will be responsible for various tasks related to Trial Product handling with focus on the temperature deviation process, temperature loggers and GCP requirements related to IRT systems, but also shipments, receipt, storage, destruction etc. You will be responsible for requirements in our global procedures for Trial Product Handling and be responsible for: Set direction for Trial Product Handling requirements
Updating and owning procedures related to Trial Product Handling
Writing deviations and change requests when needed
Training related to trial product handling
Temperature monitoring devices (ship and storage) Engage and lead projects regarding trial product handling
All things related to supporting and improving to the benefit of the Clinical sites and our colleagues in the affiliates who are responsible for overseeing the trials daily. Your contribution will ensure that all our almost 5000 clinical trial sites all over the globe are being supported in the most optimized and efficient way. You will have a direct impact on how we run clinical trials and will be involved in many important processes. In addition, you will become part of a very engaged and highly skilled team where every day will provide challenges and opportunities for learning and growth. You will work with colleagues with whom you can both learn from and have fun with. Qualifications You hold a master’s degree within pharmaceutical sciences, engineering or similar. In addition, you have: A strong quality mindset and comprehensive experience working within GxP regulated processes in the pharmaceutical industry
Sense for the detail and prefer to work in a structured way
Preferably, solid experience in working with requirements for the clinical area (GCP)
Knowledge how to navigate in a GMP/GDP/GCP regulated field and with several stakeholders involved daily
Skills within written documentation is a pre-requisite because documentation is an important part of the job
Fluent knowledge in English is a must, Danish is nice to have
You seek simple and effective solutions and see continuous improvement as a natural part of processes and are familiar with various LEAN principles. You are a team player and find motivation when reaching common goals. About the Department You will join Supply Chain Planning which is a part of Clinical Supplies in CMC Development. We are responsible for the overall planning of the production, packaging, and distribution of products for clinical trials worldwide. The department consist of four teams, supporting the execution of clinical trials by forecasting and monitoring product demand, ordering products/materials, planning the packaging and shipping of trial products and supporting the overall trial conduct at the clinical sites with a focus on trial product related processes and systems. You will be reporting to the director of the Supply Chain Planning department and be a part of the department leadership team. Working at At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Associate Manager Katrine Elkjær Mønsted at +. Deadline Apply before October, 7 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 26.9.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Måløv
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