Medical Writing Specialist, Medical Documentation

H. Lundbeck A/S; København; On-site; DKK 687,000 - 945,000; Full time

Job summary

Lundbeck is seeking an experienced regulatory medical writer to lead complex documents and advise cross-functional teams in Copenhagen. You will lead the preparation of scientifically robust regulatory documents and collaborate across clinical development and regulatory affairs.

The role emphasizes lead author responsibilities, strategic document development, and the adoption of AI-enabled authoring tools within a global team.

Qualifications

• PhD or master's in life sciences with 8+ years of regulatory medical writing experience.
• Experience as lead author on major global regulatory submissions.
• Ability to advise cross-functional teams on document strategy and development.
• Excellent written and spoken English.

Responsibilities

• Lead the development of strategic clinical and regulatory documents (e.g., briefing documents, IBs, pediatric development plans).
• Analyze and synthesize complex data into clear regulatory narratives.
• Advise teams on document strategy, content, processes and regulatory expectations.
• Plan and drive document development, review, comment resolution and finalization while ensuring quality and timelines.
• Collaborate with clinical development, regulatory affairs, pharmacovigilance and biometrics to improve authoring processes.
• Contribute to AI-enabled authoring and other technologies to improve quality and efficiency.

Skills

Regulatory writing

Clinical documentation

Lead author

Cross-functional collaboration

Education

PhD or Master’s in Life Sciences

Tools

AI-enabled authoring

Job description

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 timelines.
• Collaborate closely with colleagues across clinical development, regulatory affairs, pharmacovigilance, biometrics, and other relevant functions.
• Contributes 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 23 colleagues. Most of the team is based at our headquarters in Valby, Copenhagen, and two colleagues are based in Singapore. 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 strong emphasis on individual well-being and offer flexible working arrangements in a positive and engaged working environment.

The position is based in Copenhagen, Denmark.

What you bring to the team

Our preferred candidate has the following personal and professional qualifications:

• A PhD or master’s degree in life sciences, natural sciences, or a related discipline, combined with at least eight years of regulatory medical writing experience within the pharmaceutical, biotechnology, or CRO sector.
• Significant experience as lead author of complex clinical and regulatory documents, preferably including major global regulatory submissions, and strong analytical skills with the ability to translate complex scientific information into clear and compelling regulatory narratives.
• Demonstrated ability to advise and guide cross-functional teams on document strategy, content, and development processes, together with strong stakeholder-management skills and the ability to influence effectively in a global, cross-functional environment.
• Excellent written and spoken English.
• 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 curiosity, accountability and adaptability enable 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.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion

Annual base salary range:(687 000 - 944 900) DKK

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.

If you have questions, please contact Matilde Thye Kveiborg, Sr. Director, Medical Documentation, [e-mail].

Applications must be received by 20th September 2026.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

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

We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

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.

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.