8 дней назад
Scientific Medical Writer (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientific Medical Writer (Clinical Research) (Phase 1 Clinical Research): Writing full Clinical Study Reports, clinical trial protocols, and regulatory modules for Phase 1 clinical pharmacology studies with an accent on inspection-ready deliverables, regulatory compliance, and document quality control. Focus on authoring Health Authority responses, creating document shells, coordinating QC timelines, and improving collaboration between clinical pharmacology and document services teams.
Location: Brussels, Brussels-Capital Region, Belgium
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Write full Clinical Study Reports for Phase 1 clinical pharmacology studies.
- Develop clinical trial protocols and regulatory modules 2.7.1 and 2.7.2.
- Ensure deliverables are inspection-ready and compliant with regulatory and internal guidelines.
- Plan document writing and quality control deliverables, including timelines.
- Create document shells, drive QC processes, and coordinate deliverable planning.
- Recommend process improvements to strengthen collaboration between CPP and document service teams.
Requirements
- Strong experience writing full Clinical Study Reports for Phase 1 clinical pharmacology studies.
- Strong experience in protocol writing and Module 2.7.1/2.7.2 writing, including SBAAM and SCP.
- Required experience authoring Health Authority responses.
- Proficiency with Microsoft Word templates and document formatting.
- Excellent oral and written English communication skills.
Culture & Benefits
- Full-time employment.
- Work focused on clinical research and regulatory deliverables for innovative medical treatments.
- Collaboration across clinical pharmacology and document service teams.
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