id: NDk0ODQ4NyA3

reference: 4948487

documentId: 4948487

connectionPointId: 7

lastModificationDate: 1550661736550

stillingsbetegnelse:
Regulatory Integration Specialists – multiple positions

jobbeskrivelse:

Join a newly-created Regulatory Data Integration Team for a business-critical project in LEO’s Global Regulatory Affairs

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Following a major acquisition, we are creating a project team to drive the integration of regulatory data into our systems – a task that will be fast-paced, dynamic and challenging.

In the RA Data Integration Team you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. We are recruiting for several positions expecting to last from 7 to 9 months, with the potential for extension through 2020.

The job
As a Regulatory Integration Specialist you will be working with the transfer of a large product portfolio, ensuring that LEO takes over regulatory responsibilities. Since the product portfolio is already marketed there are ongoing submissions and transfer activities, the data for which will come from multiple sources. You will be involved in the development and execution of processes, working to tight deadlines.

• Analysing and restructuring regulatory data to ensure that it fits with LEO’s business, regulatory and technical requirements
• Entering data into LEO’s regulatory information management systems, including electronic document management systems
• Ensuring compliance needs are met and that key information is available to stakeholders at the right time to support the timely transfer of registrations
• Identifying obstacles and issues, and working with stakeholders to quickly find solutions

You will be expected to proactively develop and seek improvements to integration processes, and share this knowledge with your colleagues.

Your qualifications

• Candidates with the following skills and background are preferred:
• Master’s degree in life sciences or information sciences, or other related areas. Candidates with pharmaconomy qualifications are also welcome to apply. 
• Experience in a pharmaceutical regulatory affairs environment will ensure consideration for senior team positions.
• Awareness of the standard process of pharmaceutical drug development and registration. 
• Strong IT skills, and experience with structured information management systems.
• Able to quickly identify and find solutions to problems. Applies creative thinking to overcoming obstacles.
• Fluent in written and spoken English.

You communicate clearly and can convey complex ideas to a wide range of stakeholders. You have a focus on detail, and can be relied upon to produce work of a high quality. Finally, you are motivated by working in a dynamic, fast-paced environment.

Your new team
The RA Data Integration Team is a key part of this high-profile project. This new team of 13 people will be responsible for creating and executing data integration processes, with a focus on efficiency, quality and teamwork. You will be expected to work in close collaboration with your teammates, as well as project team colleagues from other areas of Regulatory Affairs.

For newly educated candidates, this position can serve as an introduction to the pharmaceutical industry. For experienced candidates, this position offers opportunities to use that experience to innovate and collaborate.

Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application
If you have questions, please do not hesitate to contact Alyson Dalby, RA Data Integration Lead, at +45 52 90 45 90

Please apply in English via the link at our website and remember to attach application and CV. The deadline is 15th March 2019, however we will start interviewing candidates immediately, so early applications are encouraged.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2423

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