Clinical Documentation Specialist

6 hours ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time
About the Role

Lundbeck is seeking a highly skilled Clinical Submission Coordinator to join our Medical Documentation team. As a key member of our team, you will be responsible for managing clinical documentation and ensuring the submission readiness of clinical trial reports and clinical submission documents across our clinical development programmes.

You will work closely with Medical Writers, regulatory and clinical team members, as well as external vendors to ensure the electronic integrity of the documentation and compliance with internal and external standards and requirements. Your attention to detail and organizational skills will be essential in ensuring the quality of our clinical documentation.

Your Responsibilities
  • Manage clinical documentation and ensure submission readiness of clinical trial reports and clinical submission documents
  • Collaborate with Medical Writers, regulatory and clinical team members, and external vendors to ensure electronic integrity and compliance
  • Assist in the production of documents and perform quality control
  • Involve in activities to ensure public transparency of Lundbeck's clinical research
What We Offer

Lundbeck offers a dynamic and innovative work environment where you can grow and develop your skills. As a Clinical Submission Coordinator, you will have the opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of patients. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.

Our team is committed to delivering high-quality clinical documentation that meets the rigorous standards expected by regulatory agencies. If you are a detail-oriented and organized individual with a passion for clinical documentation, we encourage you to apply for this exciting opportunity.



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