Medical Writer, Regulatory Documentation Specialist

7 days ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

Job Summary

Lundbeck is seeking a highly skilled Medical Writer to join our team in the neuro-specialty and neuro-rare fields. As a Medical Writer, you will play a crucial role in driving the development of clinical and regulatory documents that support our company's strategy.

Key Responsibilities

  • Author balanced, well-argued key documentation and provide medical writing expertise to supporting documentation
  • Plan and coordinate the preparation of documentation and ensure alignment with agreed messages
  • Analyse, summarize, and present information in high-level documents and dedicated reports
  • Collaborate with colleagues in clinical, regulatory affairs, pharmacovigilance, and biometrics to ensure clear and concise presentation of scientific information and clinical data
  • Bring technical expertise to the position and drive the implementation of new ways of working in the quickly changing technical environment

About the Team

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

  • More than 5 years of experience as a Medical Writer
  • Experience in structured authoring and/or other technical solutions to medical writing
  • Excellent analytical and communication skills
  • Fluency in spoken and written English and a passion for writing
  • Goal-oriented, systematic, and flexible
  • Strong interpersonal and communication skills in a global environment

About Lundbeck

Lundbeck is a global pharmaceutical company that 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. We offer 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.



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