stillingsbetegnelse:
GCP Experienced Professional for Non-Conformities and SOP Updates

jobbeskrivelse:
- Research & Development - Denmark - Søborg We are looking to employ a highly qualified Senior GCP Advisor working with GCP focusing on the clinical SOP update and non-conformity processes. In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society. About the department The Global Clinical Compliance department in R&D Quality is responsible for the Novo Nordisk clinical Quality Management System globally including optimising the processes and ensuring the mirroring of external requirements in the clinical SOPs. The department is divided into two teams. The open position is located in the GCC Process Support Team. We are a team of 11 experienced colleagues, valuing a friendly and warm atmosphere with room for professional development as well as a proper work life balance. The job Together your colleagues you will be responsible for ensuring that Novo Nordisk maintains one global clinical quality management system in compliance with GCP and other relevant external and internal requirements. You will provide advice on GCP and review clinical SOPs in the SOP update process and you will also be involved in cross-departmental working groups. This includes handling, evaluation and trending of non-conformities. Qualifications You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least five years’ experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience with clinical quality assurance, trial management, or monitoring is required. You take a pragmatic approach to problem solving, and have strong interpersonal skills. You are organised, detail-oriented and quality-conscious. You are a team player with a positive mind-set who thrive working across departments in an international organisation. The treatments we develop and market improve lives around the world, today and tomorrow. Even a small detail has the potential to make a big difference to our patients. Join us and your work will make a difference. 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 Malene Jagd Moe at +45 3079 3253 or Susanne Nørskov at +45 3079 8151. Deadline 20 May 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