CLINICAL SUBMISSION COORDINATOR, MEDICAL DOCUMENTATION

Lundbeck aspires to impact patients, people, and society through leading innovation within neuro-specialty and neuro-rare fields, while delivering sustainable growth as a Focused Innovator. Your dedication to this strategy is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.
If you have a desire to manage clinical documentation and ensure that our deliverables meet the rigorous standards expected by regulatory agencies, you can be our new Clinical Submission Coordinator.

APPLY NOW

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you are 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. We ask you not to include a photo or personal information that does not relate to your professional experience.
If you have questions, please contact Kerstin Dahlström, Director Transparency and Outsourcing, kerd@lundbeck.com, or Katarzyna Puton, Principal Clinical Submission Coordinator, kauo@lundbeck.com . Applications must be received by 2nd October 2024.
Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

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.

You will be responsible for managing clinical documentation and for ensuring the submission readiness of clinical trial reports and clinical submission documents across Lundbeck’s clinical development programmes. You will ensure the electronic integrity of the documentation and compliance with internal and external standards and requirements. You will assist in the production of documents and perform quality control. You will be involved in activities to ensure public transparency of Lundbeck’s clinical research.
All activities are planned and executed in close collaboration with Medical Writers, regulatory and clinical team members, as well as external vendors.
You will also be involved in the ongoing work at Lundbeck to evaluate trends, identify areas for improvement, develop and maintain processes and systems to optimize efficiency, and ensure quality in clinical documentation, as this role is continually evolving.