Medical Writing Specialist (Copenhagen)

Job summary

The role involves leading the preparation of regulatory documents that support the development and approval of medicines for brain disorders. The position requires collaboration with cross-functional teams and contributions to the enhancement of authoring practices and technologies.

Qualifications

• PhD or master’s degree in life sciences, natural sciences, or a related field.
• At least eight years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or CRO sector.
• Significant experience as lead author of complex clinical and regulatory documents, including major global submissions.
• Strong analytical skills for translating complex scientific information into clear regulatory narratives.
• Excellent written and spoken English.

Responsibilities

• Lead the development of strategic clinical and regulatory documents, such as briefing documents and Investigator’s Brochures.
• Analyze and synthesize clinical data into coherent regulatory narratives.
• Advise teams on document strategy, content, and regulatory expectations.
• Plan and drive document development, ensuring quality and adherence to timelines.
• Collaborate with various functions including clinical development and regulatory affairs.
• Contribute to the implementation of AI-enabled authoring technologies.

Skills

• Strong stakeholder-management skills and ability to influence in a global environment.
• Experience with AI-enabled authoring or digital medical-writing solutions is advantageous.

Education

• A PhD or master’s degree in a relevant field is required.

Tools

• Familiarity with AI-enabled authoring tools and structured content authoring is preferred.