stillingsbetegnelse: CTA Coordinator

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg 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. 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 strong at planning, coordination, problem solving and collaboration across the organisation? Do you have experience within clinical trial activities? Are you eager to work with clinical trial applications (CTAs) across the Novo Nordisk portfolio of projects and products? Then you might be the CTA Coordinator we are looking for in Global CTA Management. About the department The Global CTA Management department in Søborg is part of Regulatory Operations in Regulatory Affairs and works closely with stakeholders in Clinical Operations, Clinical Pharmacology, the Regulatory Affairs project teams and the affiliates. We are a team of 11 highly motivated and engaged employees. We are responsible for coordination and planning of the assembly of the document packages for CTAs to Health Authorities and Ethics Committees, in order to support the authorisations to conduct the growing number of clinical trials in Novo Nordisk. Global CTA Management is a department in constant development. It therefore offers interesting and challenging assignments and opportunities for continuous personal and professional development. The job You will have a central coordinating role in the planning, distribution/submission, approval and maintenance of worldwide clinical trial applications across the entire Novo Nordisk portfolio of projects and products. In this role, you will provide operational support as well as CTA local requirement expertise to our stakeholders across the organisation in headquarters and affiliates. As part of the Global CTA Management department and Regulatory Operations, you can also expect to take and share responsibilities in continuous improvement activities for developing, optimising and standardising the clinical trial application process. Qualifications You have a B.Sc. within natural sciences or other relevant degree and at least 2 years of experience working with clinical trial application or within clinical development. You have excellent overview, planning and coordination skills, and enjoy working in a structured way in order to meet tight deadlines. You are fluent in written and spoken English and have strong communication skills. Having a flair for IT systems and being an experienced user of Microsoft Office is essential. On a personal level, you thrive in a busy environment and bring a can-do attitude to your work. You are a strong team player, but also self-motivated and enjoy working independently. In Global CTA Management the atmosphere is informal and humorous. While we expect everyone to do their best every day, we also like to have a laugh together. If you feel the same way, you are the kind of person we are looking for. 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 Marianne Myhre Rottensten on +45 3075 1879. Deadline 4 January 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