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