Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy.Headquartered in Denmark, Novo Nordisk employs approximately 30,000 employees in 76 countries, and markets its products in 179 countries.
Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).
Post : GCP Lead Auditor
Job Description:
As an auditor you will have a high level of responsibility, and you can make a great impact.
Your key responsibility is to perform GCP audits at clinical trial sites and of Clinical Research Organisations (CROs) involved in Novo Nordisk A/S clinical research. Novo Nordisk A/S sponsors clinical trials in 70+ countries, therefore you should expect approximately 100 annual travel days outside India.
We require that you are able to work independently. It is expected, that you are analytical and pragmatic.
As an auditor you will interact and communicate effectively with external and internal stakeholders at all organisational levels, and across many different cultures.
Candidate Profile
• You hold a university degree in science or pharmaceutical sciences. You already have experience on GCP investigator site audits for at least 2-4 years, and/or you worked in clinical trials with e.g. trial management, monitoring or drug safety for at least 6-8 years. A valid certification in ISO 9001 Lead Auditor course will be an added advantage.
• You have high ethical standards and are committed to the overall aim of ensuring ethical conduct, safety of trial subjects and data integrity. You have good knowledge of good clinical practice (GCP) and good documentation practice (GDP) requirements, and you have the ability to understand and interpret the applicable standards in the field of clinical research.
• During your professional life you have certainly developed the “eye for detail”, but you put things into perspective and see the “big picture”.
• You are an open-minded person, with cultural awareness and excellent communication skills, who likes to be in daily contact with different stakeholders around the world. You thrive in a dynamic and busy environment with changing priorities. Since most of the audits are conducted outside India, you must be fluent in English both orally and in writing as well interested in travel.
Additional Information:
Qualification: University degree in science or pharmaceutical sciences
Job Location: Karnataka-Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: GCP
End Date: 20th February, 2018
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