Medical Writing Senior Specialist, Medical Documentation

Cari; København; Ibrido; DKK 786.000 - 1.081.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working arrangements

Competitive salary

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory writing

Cross-functional leadership

Analytical skills

English communication

Stakeholder management

AI-enabled authoring

Formazione

PhD or Master's in life sciences

Strumenti

AI-enabled authoring tools

Descrizione del lavoro

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.

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 atlundbeck/global/about-us/our-commitment/diversity-and-inclusion.

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.

The position is based in Valby, Denmark.

Learn more about us atlundbeck, LinkedIn or Instagram (h_lundbeck).