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reference: 4979811

documentId: 4979811

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stillingsbetegnelse:
Experienced GCP Advisor Specialist - Team player with great stakeholder management skills

jobbeskrivelse:

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

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.

 

About the department

The area R&D Quality is part of Global Development and 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, vendor assessment, trending on clinical quality signals, capture and assessment of global external legislation and guidelines 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 the GCP specialist during inspections as well as follow-up on issues from inspections. You will be involved in a cross-functional inspection readiness group and providing your expertise and support across the organisation. 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 ten years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations. Experience within clinical quality, trial management, or GCP Audit is required.

You take a pragmatic approach to problem solving and have strong interpersonal skills. You are organised, detail-oriented without losing the big picture and quality-conscious. You are a team player and you thrive working across departments in an international organisation.
 

Working at Novo Nordisk

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 Lisbeth Bonefeld at +45 3075 8096.

Deadline

Please submit your cover letter (application), CV and other relevant papers online no later than May 6, 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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR