Regulatory Medical Writing Lead for Global Submissions

Cari

København

Hybrid

DKK 786,000 - 1,081,000

Full time

2 days ago

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Benefits offered by this job

Flexible working arrangements

Competitive salary

Job summary

Lundbeck in Denmark seeks a Medical Writing Senior Specialist to shape regulatory documents for medicines addressing brain disorders. You will lead complex submissions, advise cross-functional teams, and advance our authoring practices and technologies.

You will translate extensive clinical data into clear regulatory narratives, plan document development and timelines, and collaborate with clinical development, regulatory affairs, pharmacovigilance, and biometrics.

Qualifications

Doctoral or master's degree in life sciences or related field.
At least eight years of regulatory medical writing experience.
Lead author for major regulatory submissions (BLAs/NDAs/MAAs).
Advise cross-functional teams on strategy, content, and processes.
Strong English writing and communication skills.
Experience with AI-enabled authoring or digital medical writing is a plus.

Responsibilities

Lead the development of strategic regulatory documents for submissions.
Synthesize complex data into clear regulatory narratives.
Advise teams on document strategy, content, and timelines.
Plan, drive, and finalize document development with quality and consistency.
Collaborate with clinical development, regulatory affairs, pharmacovigilance, and biometrics.
Contribute to AI-enabled authoring and other technologies.