Medical Writing Senior Specialist, Medical Documentation

Lundbeck; København; Sur place; DKK 786 000 - 1 081 000; Plein temps

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.

Connaissances

Strong analytical skills

Excellent written and spoken English

Stakeholder management

Cross-functional collaboration

AI-enabled authoring awareness

Formation

PhD or master’s degree in life sciences or related

Outils

AI-enabled authoring

Structured content authoring

Description du poste

Medical Writing Senior Specialist, Medical Documentation

Requisition ID: 8250

Location: Copenhagen, Danish Capital Region, DK

Medical Writing Senior Specialist, Medical Documentation

Do you want to shape the clinical, regulatory documents that advance the development and approval of medicines for people living with brain disorders? We are looking for a senior specialist (equivalent to Associate Director level) regulatory medical writer with extensive submission experience to lead complex documents, advise cross-functional teams, and contribute to the continued development of our authoring practices and technologies. You will bring a proven track record of leading the authoring documents for major regulatory submissions.

Your new role

You will contribute directly to Lundbeck’s development pipeline by:

• Leading the development of strategic regulatory documents, including clinical summaries and overviews, briefing documents, Investigator’s Brochures, paediatric development plans, etc.
• Analysing and synthesise complex clinical data and cross-functional input into clear, coherent regulatory narratives
• Advising clinical and regulatory teams on document strategy, content, processes, and regulatory expectations
• Planning and driving document development, review, comment resolution, and finalisation while maintaining quality, consistency, and timelines
• Collaborating closely with colleagues across clinical development, regulatory affairs, pharmacovigilance, biometrics, and other relevant functions
• Contributing to the implementation of AI-enabled authoring and other technologies that can improve the quality and efficiency of medical writing

Your future team

Medical Documentation is a global team of 24 colleagues. We combine deep clinical and regulatory expertise with strong writing, scientific narrative development, and collaboration skills. Together, we ensure that complex scientific information, clinical and regulatory strategies and trial results are communicated clearly, consistently, and in accordance with regulatory requirements. We value constructive challenge, shared accountability, quality, ethics, and transparency. We also place a strong emphasis on individual well-being and offer flexible working arrangements in a positive and engaged working environment.

What you bring to the team

To be successful in this role, you meet the following personal and professional qualifications:

• A PhD or master’s degree in life sciences, natural sciences, or a related discipline
• At least eight years of regulatory medical writing experience within the pharmaceutical, biotechnology, or CRO sector
• Extensive experience as lead author of complex clinical and regulatory documents for major global regulatory submissions (i.e., BLAs/NDAs/MAAs)
• Demonstrated ability to advise and guide cross-functional teams on document strategy, content, and development processes
• Strong analytical skills and the ability to translate complex scientific information into clear and compelling regulatory narratives
• Excellent written and spoken English
• Strong stakeholder-management skills and the ability to influence effectively in a global, cross-functional environment
• Experience with AI-enabled authoring, structured content authoring, or other digital medical-writing solutions is an advantage.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our focused innovator strategy (curiosity, accountability and adaptability) enables us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

Annual base salary range:786 000 - 1 081 300 DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

This job ad is intended for individuals seeking a career opportunity with Lundbeck.

Applications must be received by 22nd November 2026.

The position is based in Valby, Denmark.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.