stillingsbetegnelse:
Pharmacist / engineer for clinical trial labelling

jobbeskrivelse:
- Research & Development - Denmark - Måløv 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 creation of labels in our IT system (PMX) based on knowledge of the different regulatory requirements around the world, while collaborating with our trial planners, the clinical printing & packaging facility and your colleagues in the team. 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 area, 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, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Maria Forman on +45 3075 1763. Deadline 22 June 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