Scientific Advisor | Medical Writer

Experienced Scientific Advisor and Medical Writer with extensive knowledge in clinical studies and oncology, including data analysis, scientific publications and regulatory documentation (ICH GCP, MedRA).

• Clinical studies
• clinical study reports
• Editing
• Gute Klinische Praxis
• ICH guidelines
• Lay summaries
• Literature searches
• medical Writing
• Translation EN/DE

Team leader and project manager with highly refined communication skills and excellent time-management. Independent coordination of translational research projects with national and international partners. Close collaboration and communication with academic and pharmaceutical partners as well as research staff. Provision of scientific and technical support within writing and research projects, building professional and credible relationships with key opinion leaders in the field of oncology.

• Strong publication background: high throughput of peer-reviewed scientific publications (with authorship on >30 publications and medical writing acknowledgement on many more)
• Regulatory writing, clinical study documentation (CSRs, interim reporting, study protocols, ICFs), maintenance of EU Clinical Trials Register
• Within the leadership role: performing peer review and editing of documents written by other team members and external partners
• Good knowledge of ICH and other regulatory guidelines
• EMWA certified medical writing and editing skills
• Proficient in results and concept presentations: Preparation of abstracts, posters, presentations, press releases for international oncology conferences
• Writing and coordinating annual scientific reports, website and social media content
• Translation of research results for lay audience
• Leading translational research projects, including development and review of statistical analysis plan and conduct of statistical analysis
• Proficient in MS Office and statistics software SPSS; knowledge of statistics reporting software, i.e. SAS, R
• GCP certificate
• Strong leadership and management competences including resource and timeline planning
• Very well organized, targeted and self-motivated
• Sociable, open and communicable
• Long-term work experience abroad and eager to collaborate internationally
• Fluent English and German