stillingsbetegnelse:
Pharmacist / engineer for clinical trial labelling

jobbeskrivelse:
- Research & Development - Denmark - Måløv Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Are you looking for new challenges? Would you like to be part of a rapidly growing part of Novo Nordisk’s R&D organisation by developing printed packaging materials together with a dedicated team of colleagues? Then we may have a job for you. We are looking for an ambitious and talented pharmacist/engineer to our Label & DFU team who is ready to take on the responsibility of developing and coordinating labels and directions for use, for the products used in our clinical trials world-wide. About the department Clinical Supplies Trial Setup (CSTS) is a department in CMC Clinical Supplies responsible for filling, planning, packing and delivering supplies for all clinical trials in Novo Nordisk. CSTS prepare the trials for execution by reviewing the trial protocol, create the printed packaging materials and prepare the master data needed for the packaging department. We support all clinical trials conducted globally by Novo Nordisk and operate in the combined field of supply chain management and regulatory requirements within drug development. Our department consists of 3 teams: Trial Set-up Planning, Label & DFU Set-up and Trial Master Data The job The main tasks in the Label and DFU Team are preparing labels and directions for use (DFU), coordinate translations, and ensure timely approval by our affiliates world-wide. The labels and DFUs are submitted to local health authorities before initiating a clinical trial, and subsequently printed either internally at our printing and packaging facility in Måløv, or externally by our vendors in DK and abroad for use on the clinical trial products. You will be a part of the group handling the external (vendors) and internal (affiliates) contact, coordinating the translations and the internal regulatory approvals. You will be acting as the expert on the process and on GMP, supporting your colleagues in their daily tasks, developing new labels and working closely with our vendors to ensure high quality deliveries. The job consists of a good mix of daily operational tasks and issues and a long term focus on process and quality improvements. You will also take part in ensuring inspection readiness as well as supporting our aspiration to run a professional clinical supply chain through customer focus and end-to-end understanding. Qualifications We are looking for a candidate with a M.Sc. or BA preferably in pharmaceutical science or engineering or similar. Ideally you have a few years of experience with the pharmaceutical industry and the GMP requirements. You should have a structured approach to you work, be flexible and be able to stay focused when things gets busy. The job requires a strong quality mind-set as well as attention to details and deadlines, and it is carried out in collaboration with many different contacts throughout the world, so you must enjoy communicating with different stakeholders. We are looking for an ambitious team player who thrives with changes, who approaches new tasks with a lot of energy and a can-do attitude, and who will contribute to our team with new ideas and with your personality. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please contact Maria Forman on +45 3075 1763. Deadline 22 February 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark