Medical Writer
2 days ago
We are seeking a highly skilled Medical Writer with expertise in clinical research and a solid understanding of preclinical scientific work. The ideal candidate holds a PhD in a biomedical or clinical discipline and brings extensive experience developing scientific, regulatory, and clinical documentation.
In this role, the Medical Writer will work cross-functionally with Medical Affairs and Clinical Success teams, supporting communication across clinical development and translational research. This role is suited to someone who thrives in a detail-oriented but also business focused environment and can translate complex scientific concepts into clear, accurate and engaging written materials.
Key Responsibilities
- Planning, develop, write, and edit scientific and clinical documents, including:
- Clinical study protocols and clinical study reports,
- Investigator brochures
- Regulatory documents (e.g., ethics applications, informed consent forms)
- Manuscripts for peer-reviewed journals
- Scientific summaries, white papers, and conference materials
- Work cross-functionally with Medical Affairs, Clinical, Commercial, and Marketing departments to ensure alignment of clinical messaging, scientific accuracy, and documentation needs.
- Ensure all deliverables meet the highest regulatory and scientific standards.
- Support documentation needs for clinical trials across multiple phases.
- Maintain high-quality standards, ensuring accuracy, clarity, and consistency across all materials.
- Stay current with literature in relevant therapeutic areas, particularly musculoskeletal disorders and translational science.
Required Qualifications
- PhD in biomedical sciences, life sciences, medicine, or a related field.
- Demonstrated experience writing in clinical research (clinical trials, human subject studies, etc.) and regulatory documents.
- Strong understanding of research methodologies and translational frameworks.
- Excellent ability to communicate complex scientific information to varied audiences.
- Excellent ability to collaborate across functions and areas of expertise.
- Exceptional attention to detail with strong editing and project-management skills.
- Familiarity with ICH-GCP, clinical development processes, and regulatory/ethical expectations.
- Fluent in English, Swedish a bonus but not required.
Preferred Qualifications
- Experience in musculoskeletal disorders, orthopaedics, rheumatology, or related fields.
- Background in immunology or mesenchymal stem cell (MSC) research.
- Publication record in peer-reviewed journals.
- Experience in industry, CROs, academic clinical research units, or biotech/medtech organizations.
- Experience preparing documentation for ethics committees or health authorities.