Profile Details

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Hire Athalia M.

Israel

USD 85 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• Writing

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

Work Experience

Senior Biosample Operations Manager & Associate QA Manager

Compugen Ltd.

May 2022 - Present

Biosample Operations Manager

Bayer Pharma AG

February 2013 - May 2022

Clinical Trial Manager / Clinical Research Associate

Allied Clinical Management GmbH

September 2012 - February 2013

Scientific Officer (Regulatory & Communications)

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

January 2010 - August 2012

Education

Master of Science (MSc)

Beuth Graduate School of Life Sciences

October 2010 - July 2013

Bachelor of Science - BSc, Chemistry

Free University of Berlin

October 2004 - March 2009

Certifications

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

  Parexel Academy

  December 2009 - Present