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reference: 5030784

documentId: 5030784

connectionPointId: 7

lastModificationDate: 1565872223440

stillingsbetegnelse:
Clinical Compliance Manager – Clinical Process Management

jobbeskrivelse:

Do you have a strong quality mind-set and want to bring your strong GCP knowledge into play in an innovative company, which aspires to become the world leader within dermatology with an ambition to help 125 million patients by 2025?

Then this is your chance to join Global Clinical Operation R&D in LEO Pharma. We devote our efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. 

High quality clinical trial processes

You will join LEO Pharma at the maybe most exciting time in the company’s history with a strong focus on optimizing the way we work to ensure compliant, high quali-ty and efficient processes. You will be an important part of this journey by ensuring that our key procedures and processes are in compliance with internal- and exter-nal requirements, and that these key procedures and processes at the same time support a flexible and agile working environment. 

Your main tasks include:

• Being the Subject Matter Expert within GCP governing compliance within clinical trial processes and provide advice and support to the organisation
• Development and revision of clinical processes
• Provide input to revision and prioritizing
• Author / facilitate / update processes according to revision plan
• Review SOPs/flows according to revision plan
• Involvement in GCP audits/inspections
• Participate in process improvement projects
• Secure focus on process work through continuous stakeholder manage-ment

Your position will bring you a high level of visibility, as you will collaborate with a great number of stakeholders across the organisation. To succeed in this, you will need strong stakeholder management skills and a pragmatic issue solving ap-proach. 

Your qualifications and experience 

• University degree at Master’s level backed by relevant experience from the pharmaceutical sector
• Profound knowledge within ICH GCP
• Experience with audits and inspections is considered as an advantage
• Strong knowledge base of the drug development process
• A high level of stakeholder focus
• You can work independently and possess the positive can-do-attitude it takes to create new solutions
• Structured and analytical approach
• Enthusiastic, positive and comfortable cooperating and communicating across skill types and functional borders

Furthermore, you thrive in an international environment, where excellent stake-holder management is a key requirement, and in an environment characterized by on-going changes of procedures, systems and processes.

 
Your new team 

You can look forward to become part of a dedicated team of training, compliance and process managers with high professional standards in an informal atmosphere. You will be part of the Clinical Process Management team in Global Clinical Opera-tions, which is supporting the clinical operation area with many touch points out to the entire organisation. We are currently 10 people in the group and located at LEO’s headquarters in Ballerup, Greater Copenhagen.

We look forward to receiving your application.

The application deadline is the 31st of August 2019. For further information, please do not hesitate to contact Ali Ijaz, Head of Clinical Pro-cess Management (ALIDK (at) leo-pharma.com or +45 31124732).

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C1213

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR