Novo Nordisk is a global healthcare company with 89 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 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: GCP Lead Auditor
Job Description
About the department
As a GCP auditor in Novo Nordisk, you will be part of the GCP Audits team, Quality R&D Audits in Corporate Quality.
The department is located in Bangalore with the Headquarters is in Denmark, and has the global responsibility for performing audits of clinical trials throughout all development phases, as well as system audits worldwide.
The primary goal is that our audits shall help ensuring the ethical conduct, the safety of the trial subjects, and the data integrity in all clinical research sponsored by Novo Nordisk
We are dedicated to teamwork, sharing audit best practices within the department and with auditors in other areas, striving to develop a consistent auditing approach at a world-class level.
Currently, the department consists of 22 members and is composed of 3 auditor teams (two in Denmark and one in Bangalore, India).
The Job
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 80-100 annual travel days outside Denmark.
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 natural or pharmaceutical sciences. You already have experience as a GCP auditor, or you worked in clinical trials with e.g. trial management, monitoring, data management, biostatistics, or drug safety for at least 5 years.
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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 Denmark, you must be fluent in English both orally and in writing.
Additional Information:
Location: Bangalore, India
Requisition ID: 35771BR
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 16th Janury, 2016
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