stillingsbetegnelse: Label Support associate

jobbeskrivelse:
- Research & Development - Denmark - Måløv Are you looking for new challenges? Would you like to join a rapidly growing part of Novo Nordisk’s R&D organisation by creating printed packaging materials together with a dedicated team of colleagues? Then we may have a job for you. We are looking for a talented person 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, the area 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, as well as the label creation performed at our external printing vendors. We are part of the GMP production chain, therefore reviewing and documenting labels is also part of the job, as is improving your own process continuously to ensure we are staying efficient and in compliance with the regulations. Qualifications: We are looking for a candidate with an administrative background or a background in a support role preferably combined with pharmaceutical experience. You should have a structured approach to you work, be flexible and be able to stay focused when things gets busy. The job requires good communication skills, 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 engaging 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 call Team Leader Maria Forman on +45 3075 1763. Deadline 23 November 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Arbejde inden for samfundsøkonomi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark