プロフィール詳細

プロジェクトを作成

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Athalia M.に依頼

Israel

Medical Writer & Clinical Documentation Expert | MSc Clinical Trials | DE/EN | GCP/SOPs

プロフィール概要

I’m a remote-based Medical Writer and Clinical Documentation Specialist with over 15 years of experience in pharmaceutical development, working across regulatory authorities, CROs, biotech, and the pharmaceutical industry in Germany and Israel. My expertise covers the full spectrum of clinical trial documentation: SOPs, lab manuals, biosample management plans, CRFs, QA reports, and regulatory support content. I hold a Master of Science in Clinical Trial Management and a Bachelor of Science in Chemistry. I combine scientific accuracy with clear and concise writing that meets ICH-GCP and regulatory requirements. In my previous roles, I’ve contributed to oncology trials, supported biomarker and PK documentation, reviewed clinical sample sections for protocols, and co-managed QA systems and audits. I’m fluent in German and English and experienced in working across global teams. I’m available for freelance projects related to medical and regulatory writing, SOP development, QA documentation, and scientific content editing. I offer high-quality deliverables, fast turnaround, and strong communication. Let’s connect to see how I can support your team or project.

専門分野

• ★ Clinical Trials
• ★ Medical Writing
• ★ SOP & Protocol Writing
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trial Design
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Regulatory Affairs
• ☆ Supply Chain & Logistics
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Medical Content Writing
• ☆ Patient Education Materials
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing

職務経験

Senior Biosample Operations Manager & Associate QA Manager

Compugen Ltd.

5月 2022 - 現在

Biosample Operations Manager

Bayer Pharma AG

2月 2013 - 5月 2022

Clinical Trial Manager / Clinical Research Associate

Allied Clinical Management GmbH

9月 2012 - 2月 2013

Scientific Officer (Regulatory & Communications)

Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines)

1月 2010 - 8月 2012

学歴

Master of Science (MSc)

Beuth Graduate School of Life Sciences

10月 2010 - 7月 2013

Bachelor of Science - BSc, Chemistry

Free University of Berlin

10月 2004 - 3月 2009

認定資格

• Advanced Training Program: Clinical Research Associate - Clinical Logistics Manager

  Parexel Academy

  12月 2009 - 現在