Medical Writing Specialist, Medical Documentation
Lundbeck
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.
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.
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.
Apply now
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.
If you have questions, please contact Matilde Thye Kveiborg, Sr. Director, Medical Documentation, [email protected].
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.