Senior Regulatory Medical Writer — AI-Enabled Authoring

Lundbeck A/S, H

København

Sur place

DKK 786 000 - 1 081 000

Plein temps

Il y a 2 jours

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Résumé du poste

Lundbeck in Copenhagen seeks a Senior Medical Writer to lead the development of strategic regulatory documents and provide expert guidance across cross-functional teams. You will synthesize data into regulatory narratives and drive document strategy, timelines, and quality for major submissions.

We value extensive experience in regulatory medical writing, including global submissions, and the use of AI-enabled authoring to improve efficiency.

Qualifications

PhD or master’s in life sciences, natural sciences, or related field.
At least eight years of regulatory medical writing experience.
Lead author of complex clinical and regulatory documents for major global submissions (BLAs/NDAs/MAAs).
Ability to advise cross-functional teams on document strategy, content, and processes.
Excellent written and spoken English; strong stakeholder management.

Responsabilités

Lead development of strategic regulatory documents including clinical summaries and overviews.
Analyse and synthesise complex clinical data into clear regulatory narratives.
Advise teams on document strategy, content, processes, and regulatory expectations.
Plan and drive document development, review, and finalisation with quality and timelines.
Collaborate with clinical development, regulatory affairs, pharmacovigilance, biometrics, and related functions.
Contribute to AI-enabled authoring and other technologies to improve quality and efficiency.