GCP Advisor Specialist for R&D Quality

• Clinical Development & Medical
• Søborg

Do you wish to work in a highly professional and engaged global environment using your solid GCP knowledge, working with process optimisation and using your quality mind-set? Then you may be our new GCP Advisor Specialist.

About the Department

The area R&D Quality is part of Global Development. In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction as well as life cycle management. 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.

R&D Quality is divided into three departments. The open position is as a GCP Advisor Specialist in Global Clinical Quality & Intelligence department. The department is responsible for GCP Inspection coordination, GCP Training, GCP Advice and Support to our global organisation, capture and assessment of global external legislation and guidelines, participation in cross organisational improvement projects and quality management reviews (QMRs).

The Position
As a GCP Advisor Specialist you are responsible for developing and maintaining our quality management system, with a strong focus on GCP and compliance globally. Together with 8 colleagues, you will ensure that Novo Nordisk maintains one global clinical quality management system in compliance with GCP and other relevant external and internal requirements. You will be working in a department where flexibility on tasks is required. The tasks include acting as a strong Quality Partner for our clinical colleagues in HQ and furthermore what is unique about this role is your global responsibility where you will be collaborating and become a close partner to our offices outside of Denmark. Therefore, the role requires you to be proactive, have a high focus on communication and a global mindset.

You will also be involved in GCP training activities and you should expect to be involved in stakeholder meetings and cross-organisational improvement projects.

Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 7 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management, or GCP Audit is required.

You take a pragmatic approach to problem solving and you are eager to optimise and simplify processes around you. You are proactive and have strong communication and interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. You are a team player and you thrive working across departments in an international organisation.

Millions rely on us

To work for Novo Nordisk, you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange we offer the change to be a part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Contact

For further information, please contact Lisbeth Bonefeld at +45 3075 8096.

Deadline
20. October 2019.

We will be screening and interviewing on an ongoing basis.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.