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Meine Qualifikationen
Cardiology
Cardiology focuses on the diagnosis, treatment, and prevention of heart and vascular diseases. Accurate communication of clinical and regulatory data in this area requires precision and deep knowledge of cardiovascular research.
Experience Summary
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Over 10 years of experience in cardiology medical writing.
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Prepared clinical trial protocols, investigator brochures, CSRs, safety reports, and manuscripts for regulatory submissions and publications.
Key Projects / Achievements
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Lead writer for Phase II–IV heart failure and coronary artery disease studies.
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Developed KOL-facing scientific communications including abstracts, posters, and CME slide decks.
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Authored regulatory documents for FDA, EMA, and global submissions.
Document Expertise
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Protocols, CSRs, IBs, Safety Narratives, Clinical Overviews, Manuscripts, Publication Plans
Skills & Tools
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ICH Guidelines, FDA/EMA regulatory standards, MS Word, EndNote, eCTD, Project Management
Endocrinology
Endocrinology deals with hormone-related disorders, including diabetes, thyroid disorders, and metabolic diseases.
Experience Summary
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Drafted and reviewed protocols, CSRs, and safety reports for diabetes and metabolic syndrome studies.
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Worked with global sponsors to deliver accurate regulatory documents and publications.
Key Projects / Achievements
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Lead writer for insulin and GLP-1 receptor agonist studies.
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Developed patient education materials and KOL communication resources.
Document Expertise
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Protocols, CSRs, IBs, PSURs, Manuscripts, Clinical Overviews
Skills & Tools
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Regulatory compliance, EndNote, Cross-functional collaboration, Project management
Gastroenterology
Gastroenterology involves diseases of the digestive system, including liver and bowel disorders.
Experience Summary
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Prepared clinical and regulatory documents for inflammatory bowel disease, liver, and GI tract clinical trials.
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Supported KOL communication and publication planning.
Key Projects / Achievements
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Developed clinical overviews and CSRs for global submissions.
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Mentored junior medical writers in gastroenterology document preparation.
Document Expertise
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Protocols, CSRs, IBs, Safety Reports, Clinical Overviews, Manuscripts
Skills & Tools
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ICH and FDA guidelines, Project coordination, SOP development
Oncology
Oncology focuses on cancer diagnosis, treatment, and research. High-level regulatory and scientific communication is critical in this area.
Experience Summary
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Drafted and reviewed clinical trial protocols, CSRs, IBs, and safety narratives for various oncology studies.
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Experienced in publication planning and manuscript development for hematologic and solid tumors.
Key Projects / Achievements
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Lead writer for Phase II/III clinical trials in hematology and solid tumors.
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Developed safety reports, regulatory submissions, and KOL materials for oncology sponsors.
Document Expertise
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Protocols, CSRs, Safety Reports, IBs, Manuscripts, PSURs, iPSP/PIP
Skills & Tools
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FDA/EMA submissions, EndNote, SOPs, Cross-functional team leadership
Neurology
Neurology addresses disorders of the central and peripheral nervous system, including neurodegenerative diseases and epilepsy.
Experience Summary
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Prepared regulatory and scientific documents for clinical trials in multiple neurological conditions.
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Developed KOL communication materials, training decks, and manuscripts.
Key Projects / Achievements
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Authored CSRs and clinical overviews for CNS drug trials.
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Mentored medical writers in neurology documentation.
Document Expertise
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Protocols, CSRs, IBs, Safety Reports, Clinical Overviews, Manuscripts
Skills & Tools
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ICH Guidelines, FDA/EMA compliance, Project management, Team mentoring