Medical Writing Specialist, Medical Documentation

Opportunity summary

Employment type: FULLTIME. Do you want to shape the clinical and regulatory documents that advance the development and approval of medicines for people living with brain disorders? We are looking for an experienced regulatory medical writer to lead complex documents, advise cross-functional teams, and contribute to the continued development of our authoring practices and technologies. The level of the position may be adjusted based on the successful candidate’s experience and expertise. Your new role You will contribute directly to Lundbeck’s development pipeline by leading the preparation of clear, scientifically robust regulatory documents. As lead author and/or project medical writer, you will: Lead the development of strategic clinical and regulatory documents, including briefing documents, Investigator’s Brochures, pediatric development plans, and other strategic regulatory documents. Analyze and synthesize complex clinical data and cross-functional input into clear, coherent regulatory narratives. Advise clinical and regulatory teams on document strategy, content, processes, and regulatory expectations. Plan and drive document development, review, comment resolution, and finalization while maintaining quality, consistency, and timelines1 …

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