プロフィール詳細

プロジェクトを作成

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Marko K.に依頼

Germany

Pharmacist & Regulatory Affairs Consultant | Expertise in Clinical Research & Medical Writing

プロフィール概要

Pharmacist | Regulatory Affairs & Clinical Compliance Specialist Experienced pharmacist with a background in GDP logistics, medical devices, and pharmaceutical operations, now specializing in Regulatory Affairs, Clinical Research, and Pharmacovigilance. With hands-on expertise in pharmaceutical supply chains, compliance, and patient care, I help companies navigate regulatory requirements, ensure safety monitoring, and optimize clinical documentation. 🔹 Expertise: • Regulatory Affairs: Dossier preparation (CTD), SmPCs, PILs, compliance strategies • Clinical Research: Protocol review, regulatory submissions, medical writing • Pharmacovigilance: Safety reports, risk management, compliance with EU regulations • GDP & Medical Devices: Quality assurance, logistics compliance, market access Bridging clinical practice and regulatory strategy, I transform complex data into submission-ready, compliant, and impactful documentation. Let’s collaborate!

専門分野

• ★ Pharmacovigilance/Drug Safety Monitoring
• ★ Regulatory Affairs
• ★ Medical Writing
• ☆ Data Analysis
• ☆ Data Management
• ☆ Pharmacy
• ☆ Medical Devices

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, General Proofreading & Editing, Translation

Research Market Research, User Research, Scientific and Technical Research

Consulting Business Strategy Consulting, Healthcare Consulting, Regulatory Consulting

職務経験

Regulatory Affairs & Market Access Consultant

PharmaFlex24 UG (haftungsbeschränkt)

4月 2025 - 現在

Regulatory Affairs Project Associate (later Project lead)

PharmaFlex24 UG (haftungsbeschränkt) - pre-establishment freelance projects

5月 2021 - 3月 2025

Regulatory Support Assistant (Freelance)

Freelance / Remote Projects

7月 2021 - 3月 2024

学歴

MBA

Faculty of Economics and Business, Zagreb, Croatia

9月 2011 - 9月 2014

Mag.pharm.

Faculty of Pharmacy and Biochemistry, Zagreb, Croatia

7月 2000 - 7月 2006

認定資格

• ICH Good Clinical Practice (E6 R2)

  ICH (International Council for Harmonisation)

  https://ichgcp.net/

  1月 2025 - 現在

• WHO Pharmacovigilance

  Pharmacovigilance: Ensuring the Safe Use of Medicines

  https://openwho.org/courses/pharmacovigilance

  1月 2025 - 現在

• EMA EudraVigilance Awareness

  EudraVigilance Awareness Training

  https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance

  1月 2025 - 現在

• Medical writing

  University of Chicago / Coursera

  https://www.coursera.org/learn/medical-writing

  1月 2025 - 現在

• Approbation as Pharmacist (Germany)

  Regierung von Oberbayern

  5月 2015 - 現在

出版物

DISSERTATION THESIS

Marko Kokot (2014). Strategic analysis of the retail pharmacy industry in Koprivnica - Krizevci County.

Marko Kokot (2006). Simulation of the spreading of the chlorine cloud after a catastrophe in the Ivanscak water source in Koprivnica.