Dr. Katrin Zaragoza Dörr

Regulatory Medical Writing Lead of high priority clinical development program. Oversight of regulatory deliverables (including forecast, budget, resources and vendor).

Regulatory & MedComm Medical Writing Services Trilingual writing services provided (English-German-Spanish), Briefing Documents, Clinical Study Protocols & informed consents; Clinical Study Reports; Investigator's Brochures; DSURs; Patients' narratives; Manuscripts for peer-reviewed journals (e.g., nonclinical and clinical research results) Publication plan management; Slide decks; Conference Communications.

Medical Writer in Clinical Oncology R&D: -Documents written: Investigator's Brochure, DSUR, manuscripts for peer-reviewed journals (Phase 1 and review), protocol synopsis, protocol amendment, Clinical Study Report Erratum, communications at medical congresses. -Therapeutic areas covered: Solid tumors, hematological malignancies, ovarian cancer, breast cancer, small-cell lung cancer. -Phases covered: 1, 2 and 3. -Extensive training in clinical study reports

-Medical support to Investigators for conception, design, implementation, conduct and reporting of trials -Medical Writing (study protocols/amendments, informed consents, communications at medical congresses, journals, synopsis for funding request, etc) -Publication plan strategy -Scientific point-of-contact for medical leaders, pharma, etc. -Responses to medical queries of EECC/RA -Scientific review of study documents -Development of SOPs -Support organization of clinical educational events

Clinical Trials in Oncology (Non-small Cell Lung Cancer); phase 2 and 3. -Coaching, training and mentoring of junior colleagues -On-site competency evaluation of entry level CRA -Organization and coordination of CRA task force team

Monitoring of multicenter, international studies, phase 2 and 3. Therapeutic areas of Rheumatoid Arthritis and HIV.

-Co-monitoring visits of phase 1, 2, 2b and 3b trials in the therapeutic areas of Alzheimer's Disease, Urology, Diabetes, Oncology and Osteoporosis (Monitoring Visits, pre-Study Visit, Site-Initiation Visit) -Autonomous query resolution in the transfer process between sponsors of a Leukemia study -TMF filing and QC

Position in basic and applied biomedical research center, in the Department of Cell and Developmental Biology.

Position in biomedical research insitute, in the department of Tumorigenesis and Cell Differentiation.

Position in comprenhensive cancer research center in the department of Experimental Oncology.

Research institute in the field of Molecular Biology, Department of Medical Biochemistry, cell signaling pathways

Advanced workshops with EPDP credits (EMWA Conferences 2018 and 2019)

-Literature Reviews for Medical Devices -Writing Clinical Evaluation Reports -Medical Writing for Non-interventional and Database Studies -Introduction to the Paediatric Investigation Plan -Serving Two Masters: Comparing and Contrasting US and EU Reg

-Clinical Study Reports: Mastering the Essential Skills -Scheduling and Proposal Writing: The Clinical Study Protocol and Report -Writing Global Submission Dossiers using the Common Technical Document -Managing the Clinical Study Protocol Writing Process -Manuscript Writing -Summarising