Jakub Rychter

**Medizinische Fachübersetzungen (DE/NL → EN)** Als promovierter Biomediziner mit über 12 Jahren Erfahrung bin ich auf die Übersetzung medizinischer Unterlagen ins Englische spezialisiert. **Meine Leistungen umfassen:** - Patientenakten und Krankenhausunterlagen - Arztbriefe und Entlassungsberichte - Radiologie- und Pathologiebefunde - Laborbefunde und OP-Berichte Alle Übersetzungen werden persönlich und medizinisch präzise angefertigt – ohne Outsourcing. https://medexpub.com/de/

Translation and proofreading of: - Marketing authorisation documents and communications - SOP on signal detection for veterinary medicinal products - Ethics Committee (EC) / Institutional Review Board (IRB) approvals & communications, regulatory authority correspondence (e.g., Swissmedic, BfArM, Paul Ehrlich Institute) - Site initiation documents, Case Report Forms (CRFs), source documents - Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction (SUSAR) reports - Round robin test repor

Translation and proofreading of: - Benefit-risk assessment for a serotonergic medication used to treat seizures - SOP on pharmacovigilance-relevant changes to product information for medicinal products - Study protocols, protocol amendments, Investigator Brochures (IB) - Discharge summaries - Laboratory test results – blood work, biopsies, imaging reports (X-rays, MRIs, CT scans, ECG, endoscopies) - DIN EN ISO 17025:2018 accreditation materials for human molecular genetics laboratories - Audit report for a

Translation and proofreading of: - SOP on pharmacovigilance training - Medical reports and diagnostic tests/procedures - Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction (SUSAR) reports - Product information for a wound irrigation solution and wound spray - Clinical Evaluation Report (CER) for an implantable polyesterurethane fleece - Marketing authorisation documents and communications - Site initiation documents, Case Report Forms (CRFs), source documents - Ethics Committee (EC

Translation and proofreading of: - Study protocols - Medical history and patient records - Medical reports and diagnostic tests/procedures - Pathology reports – microscopy, histology, cytology - Laboratory test results – blood work, biopsies, imaging reports - Ethics Committee (EC) communications, regulatory authority correspondence

In this role, I investigated how mast cells and the enteric nervous system communicate and how mast cell activation influences the motor function of the human gastrointestinal tract. My work involved both laboratory experiments and data analysis to better understand these mechanisms and their potential clinical relevance. Key Responsibilities: - Reviewed existing literature to assess relevant studies, evaluate methodologies, and identify knowledge gaps, providing a foundation for experimental design and a

In this role, I investigated how the immune system interacts with the cellular and neuronal components of the gastrointestinal tract, focusing on intestinal barrier function. My work combined in vivo techniques, imaging, and statistical analysis to explore the underlying mechanisms of cellular communication. Key Responsibilities & Training: - Conducted in-depth research on gut immunity and its cellular and neuronal interactions - Developed expertise in in vivo techniques to assess intestinal barrier funct

Oversaw compliance with pharmaceutical regulations and standard operating procedures for generic medicinal products within the Department of Pharmaceutical Affairs. Key Responsibilities & Activities: - Reviewed and revised quality documents, including Certificates of Analysis and other regulatory records - Completed and maintained quality assurance documentation to support compliance and audits - Investigated and resolved deviations by identifying root causes and implementing corrective actions - Prepared