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Clinical Documentation Specialist
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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.
Key Responsibilities- Manage clinical documentation and ensure electronic integrity of the documentation
- Ensure compliance with internal and external standards and requirements
- Assist in the production of documents and perform quality control
- Be involved in activities to ensure public transparency of Lundbeck's clinical research
We are a team of 12 colleagues in Medical Documentation, based in Lundbeck Valby with two colleagues located in Singapore. We are imaginative, passionate, and responsible towards our deliveries, colleagues, and society. Ethics and transparency are key drivers. We focus on the well-being of the individual and offer flexible working conditions in a positive and engaged working climate.
Requirements- degree in life science and knowledge of the pharmaceutical industry
- strong organizational skills and a methodological approach to work
- drive for and experience with how IT and systems can facilitate processes and procedures
- experience with clinical documentation, ideally related to clinical trials
- familiarity with Documentum-based systems and advanced knowledge in word-processing programs and how they can be applied to clinical documentation
- strong interpersonal and communication skills in a global environment
- fluency in spoken and written English
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability, and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
