Senior Regulatory Medical Writer — Global Submissions Lead

Lundbeck; København; Vor Ort; DKK 786.000 - 1.081.000; Vollzeit

Zusammenfassung

Lundbeck in Denmark is seeking a Medical Writing Senior Specialist to lead regulatory documents for major submissions. You will craft strategic clinical summaries and overviews, advise cross-functional teams, and drive document development from planning to finalisation.

With a PhD or MSc and eight-plus years in regulatory medical writing, you will influence global filings (BLAs/NDAs/MAAs) and champion AI-enabled authoring to improve quality and efficiency while upholding regulatory standards.

Qualifikationen

• PhD or Master's in life sciences or related discipline.
• Minimum eight years regulatory medical writing experience.
• Lead author for major global regulatory submissions (BLAs/NDAs/MAAs).
• Advise cross-functional teams on document strategy and processes.
• Strong analytical skills; translate complex data into regulatory narratives.
• Excellent written and spoken English.
• Strong stakeholder-management in global settings.
• Experience with AI-enabled authoring or digital medical-writing solutions is a plus.

Aufgaben

• Lead strategic regulatory documents including summaries, briefs, and IBs.
• Analyse complex clinical data and synthesize into regulatory narratives.
• Advise teams on document strategy, content, processes and expectations.
• Plan and drive document development, reviews, and finalisation with timelines.
• Collaborate with clinical, regulatory, pharmacovigilance, biometrics, and others.
• Support AI-enabled authoring and related technologies to improve quality.

Kenntnisse

Regulatory writing

Medical writing

English proficiency

Stakeholder management

AI-enabled authoring

Cross-functional leadership

PhD/MSc

Global submissions

Ausbildung

PhD or MSc in Life Sciences

Jobbeschreibung

Lundbeck in Denmark is seeking a Medical Writing Senior Specialist to lead regulatory documents for major submissions. You will craft strategic clinical summaries and overviews, advise cross-functional teams, and drive document development from planning to finalisation.

With a PhD or MSc and eight-plus years in regulatory medical writing, you will influence global filings (BLAs/NDAs/MAAs) and champion AI-enabled authoring to improve quality and efficiency while upholding regulatory standards.