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Lundbeck Regulatory Data Manager - RIMS Business Administrator in Copenhagen, Denmark

Regulatory Data Manager - RIMS Business Administrator

Requistion ID: 5304

Location:

Copenhagen, Danish Capital Region, DK

Regulatory Data Manager – RIMS Business Administrator

We are looking for a business administrator for our regulatory information management system (RIS). The RIS team, part of Lundbeck’s Global Regulatory Operations department, is responsible for the management of data entry and daily support for end users, to ensure accuracy and quality of key regulatory data within the system.

The team operates from our Headquarter in Valby and is a dedicated and dynamic group composed of Lundbeck’s employees, external consultants and student helpers.

Your future team

The RIS team, part of Lundbeck’s Global Regulatory Operations department.

In Lundbeck, our commitment is embedded in our Danish heritage, our solid foundation ownership and our culture of innovation. To us, it is essential that Lundbeck is a place where you grow and thrive both personally and professionally.

Together, we are creating a brighter future for people living with brain diseases. That is our promise to each other and to the world.

Lundbeck offers a great workplace that is based on a flat structure, forming a

collaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.

Your new role – why is this a great opportunity?

In this role, you will support and coordinate daily activities as well as initiate and/or drive process optimization projects ensuring that the database is constantly supporting regulatory guidelines together with the RIS team lead.

Your main areas of responsibility will be within data management, including:

  • Run and participate in projects for optimizing the use of RIS

  • Data entry and data quality activities

  • Data analytics and reporting

  • Daily support and problem resolution for end users

You will also be directly involved in the development and delivery of training, participate in process optimization activities and support audits/inspections.

What you bring to the team

This position requires a service-oriented, high data quality, structured and regulatory mindset as it will be engaged in collaboration with cross-functional stakeholders as well as the system vendor to ensure operational excellence and high level of compliance of Lundbeck’s regulatory data management.

Our preferred candidate has the following personal and professional qualifications:

  • Experience from working within Regulatory Affairs, Regulatory Processes and Operations is an advantage

  • Interested in working with IT systems and databases

  • Service minded, highly structured and detail-oriented

  • Analytical, goal oriented and strong finisher

  • Fluent in English

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Ida Bastian Brügger, Director Regulatory Data & Submission Management and RIS system owner, on IDBA@lundbeck.com or +45 30 83 36 46.

Applications must be received by the 7th of June 2024.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion .

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

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