stillingsbetegnelse: Regulatory Professional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Regulatory professional for Global CTA Management.Are you strong at planning, coordinating, problem solving and collaborating with various stakeholders across the organisation? Do you have experience with 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 Regulatory Professional 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 is a centralised unit working 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 planning, coordinating, compiling and tracking of the document packages for CTAs submitted to Health Authorities and Ethics Committees worldwide and hereby contribute to the extensive processes supporting the conduct of the growing number of clinical trials in Novo Nordisk. Global CTA Management is a department in constant development and we are working closely with our stakeholders to continuously improve our processes to adapt and ensure compliance with the increasingly complex regulatory environment. We offer interesting and challenging assignments and good opportunities for continuous personal and professional development. The Job You will have a central coordinating role in the planning, distribution and maintenance of CTAs for submission and approval worldwide thereby supporting 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 HQ and affiliates. Additionally, you will provide daily support to the CTA coordinators within the department in problem solving activities making use of your broad knowledge and experience with clinical trial activities and strong analytical skills. You will be representing Global CTA Management in various cross-functional groups and projects across the organisation involved in the continuous improvement activities for developing, optimising, and standardising the Novo Nordisk CTA process. Qualifications You have a MSc within natural sciences or other relevant degrees and have at least 3 years of experience working with CTAs or the trial initiation phase within clinical trial management. You have excellent planning and coordination skills and enjoy working in a structured way in order to meet tight deadlines. You strive for simplicity and for optimising and improving processes. 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 positive can-do attitude to your work. You are a strong team player and enjoy working in a diverse working environment with various stakeholders globally and across the organisation. 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 Camilla Wamberg at +45 3079 8207. Deadline 11 January 2016.

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