Advanced Medical Writer

• Managed the client by providing end-to-end support.
• Drafted and reviewed key regulatory documents SOP (IB, Protocols, CSRs, Modules 2.2, 2.4, 2.5, 2.6 and 2.7, briefing book, scientific advice).
• Manuscript writing.
• Collaborated with cross-fun

• Analytische Chemie
• Compliance Manager
• Klinische Forschung
• Medical Writing10 J.
• Projektadministrator
• Projektmanagement
• Regulatory Affairs5 J.
• Spss

• Support the medical and scientific input to clinical research programs including review preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting.
• Write, edit, and format a wide range of documents (of low to high complexity) required for research, non-clinical (Module 2.4, 2.6 and toxicity evaluation), clinical development (Module 2.5, 2.7, CSR, Protocol, IB) and post-approval life cycle management largely according to standard procedures.
• Coordinate the document preparation, review, and approval.
• Check and revise documents with regard to scientific content, completeness, consistency, and standards compliance.
• Support the implementation of role-relevant tools, guidelines, SOP documents and templates, instructions, and/or training materials.
• Perform with limited supervision complex medical writing tasks for programs and/or low to high complexity documents, where some adaptation of standard procedures is required.