Medical Writer

✨ Role & Responsibilities
As a Medical Writer at OPIS, you will:

• Collaborate with the Head of Medical Writing to set priorities and manage daily tasks
• Ensure all documents meet the highest scientific and quality standards
• Support the improvement of internal processes and workflows
• Safeguard confidentiality, privacy, and compliance at every step

📌 Job Summary
In this role, you’ll be responsible for creating and editing a wide variety of clinical and regulatory documents, such as:

• Study protocols & reports
• Patient information & informed consent forms
• Investigator’s Brochures, IMPDs, and other regulatory documents
• Abstracts, manuscripts, posters, and slide presentations

You’ll collaborate with multiple stakeholders across teams, always ensuring compliance with international guidelines and project timelines.

🛠 Duties & Tasks

• Draft, edit, and review clinical and regulatory documents
• Develop manuscripts, abstracts, posters, and presentations
• Prepare documents for drug development and regulatory submissions
• Work closely with Biometrics, Pharmacovigilance, and Clinical Operations
• Produce submission-ready deliverables for clients and regulators
• Conduct literature searches and reviews for scientific background
• Ensure quality, accuracy, and compliance with ICH-GCP and SOPs
• Maintain audit trails and properly archive all documents
• Keep systems (e.g. TRACK) updated with required information

🎓 Requirements

• Bachelor’s or Master’s degree in biomedical/scientific disciplines
• Strong knowledge of medical concepts and terminology
• Familiarity with ICH-GCP guidelines and clinical research methodology
• Fluent English, with strong biomedical/technical writing skills
• Excellent organizational and planning skills
• Strong communication and teamwork mindset

💡 What We Offer

• Competitive salary, benefits, and bonuses
• Opportunity to grow your career in a global CRO
• Continuous professional development in an expanding company

🌐 About OPIS
OPIS is an International CRO with 25+ years of experience in conducting Phase I–IV, non-interventional, and medical device studies worldwide. We combine scientific expertise with state-of-the-art technology to manage complex clinical trials and deliver high-quality results.

With global operations and expertise across all phases of drug development, OPIS offers a full range of clinical research services:
🧪 Scientific advice & medical writing
🚀 Study start-up & trial management
📊 Data management & statistics
🛡 Pharmacovigilance & quality assurance
💻 Electronic data capture & training

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