Dr. Marcin Dudek
Skills And Services Offered:
Medical Writer and Clinical Operations/Project Manager with over 20 years experience in Pharma Industry, working for small and large biotechnology/pharmaceutical companies and CROs. Offering flexible services in preparing and writing of various documents related to clinical studies (Phase I-IV, Bioequivalence, NIS, PASS, DUS), including, but not limited to the following:
• Study Protocols, informed consent forms & patient information sheets
• Patient leaflets & recruiting materials
• Clinical Study Reports - to ICH E3 standards
• SAE narratives
• Study/Protocol Synopses
• Investigators Brochures
• Manuscripts, journal articles
• Posters, abstracts & slide presentations.
Also offering consulting in the field of local law requirements for study documents as well as setting, management and co-ordination of clinical projects in Poland. Preparing documents in Polish language as required by Polish authorities and offering translation of study documents into Polish.
Key specialities include: cardiology, asthma and COPD, rheumatology, other internal diseases, oncology, infectious diseases, neurology and psychiatry. Flexible and happy to tackle other therapeutic areas as required.
Graduated from Medical University of Warsaw, Poland in 1994. Since then working for Pharmaceutical Industry. With strong clinical development background having worked for small and big pharma companies and CROs, in different positions, both on local and global basis. My portfolio includes trainings in clinical development, ICH requirements, Polish and international law requirements, medical writing and statistics. Lecturer at many trainings, symposia and conferences.