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GCP Compliance Manager, Specialist

 
Requistion ID:  1990
Location: 

Valby, Hovedstaden, DK

Date:  09-Jun-2021
 

GCP Compliance Manager, Specialist 

Clinical Operations

 

We are expanding our portfolio and therefore looking for GCP Compliance Manager, Specialist in Clinical Operations. Do you want to contribute to restore brain health for patients worldwide? Are you passionate about ICH-GCP in clinical research and working in an international environment, then we have a position as GCP Compliance Manager, Specialist at Lundbeck for you.

 

The position is working out of Lundbeck’s headquarters in Valby.

 

Our department is responsible for planning, managing and coordinating international clinical phase I-IV studies as well as conduct of non-interventional studies. In total, we are 35 employees who perform clinical studies in more than 50 countries worldwide.

 

Your job

As the GCP Compliance Manager, specialist you are overall responsible for:

  • Providing GCP consultancy and recommendations /advice on complex process issues including mentoring and training on Lundbeck procedures as required
  • Contribute to defining and maintaining the process for CRO oversight including review of CRO SOPs,
  • Identifying and resolving gaps in processes between CRO and Lundbeck appropriately
  • Key contact person for process related activities across divisions and departments
  • Coordinates with QA and the respective Study Manager for preparatory activities for audits and inspections
  • Coordinate CAPA work as well as ensuring knowledge sharing and efficient handling and communication of CAPAs
  • Maintenance and development of the processes for clinical development ensuring that the processes for planning and execution of clinical studies are effective, compliant and simple to follow.

 

We offer

We offer an interesting job in an ever more demanding area of the pharmaceutical industry. We invite you to be part of our Clinical Operations Division, where we share the common aspiration to become world-class in study execution. We are imaginative, passionate and responsible towards our deliveries, colleagues and society. We offer a positive and engaged working climate in a global environment, flexible working conditions and good career opportunities.

 

Your qualifications
Our preferred candidate has the following profile:

  • MSc level within medical, pharmaceutical, or biological sciences
  • in-depth knowledge of ICH-GCP, other applicable regulations and laws and clinical study management
  • thorough understanding of process development, risk and issue handling and knowledge management
  • ability to facilitate and support problem solving and efficient decision making
  • strong team worker
  • drive performance and commitment through strong communication that enables effective collaboration with stakeholders from diverse disciplines.
  • international experience and a multicultural mind-set
  • able to maintain a broad overview together with a sufficient level of detail
  • quality mind-set.
  • fluent in written and oral English.

 

Further information
If you wish to know more about this job opportunity, please contact Director, Clinical Operations, Hanne Kusk Jacobsen +45 3083 2661 

We also recommend you visit our website www.lundbeck.com.

 

Your application
Please apply for the job via link below. Applications must be received no later than July 2nd 2021.

 

 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.