About The Position
Excelya is seeking a Senior Medical Writer with expertise in lay language writing to support their Medical Writing department. The role focuses on preparing patient-facing documents, such as lay summaries of Clinical Study Reports and plain language protocol synopses, ensuring scientific accuracy and adherence to EU CTR/CTIS plain-language expectations. This position involves coordinating authoring activities, document planning, and managing review cycles with stakeholders, while maintaining a patient-centric tone and respecting confidentiality.
Requirements
- Several years of clinical/regulatory writing experience
- Degree in Life Science, Pharmacy, Medicine, or a related scientific field
- Mandatory expertise in lay-language writing
- Mandatory expertise in Health literacy principles
- Mandatory expertise in Patient-centric tone
- Mandatory expertise in Neutrality and accuracy
- Mandatory expertise in Respect confidentiality, data protection, access controls
- Experience with EU CTR 536/2014
- Experience with CTIS deliverables
- Experience with Readability tools
- Experience with Health literacy approaches
- Autonomous writing in English
Responsibilities
- Drafting and revising lay summaries of Clinical Study Reports (CSR lay summaries)
- Drafting and revising protocol synopsis in lay language (Plain Language Protocol Synopsis)
- Coordinating authoring activities, document planning, and review cycles with stakeholders
- Maintaining scientific accuracy
- Meeting EU CTR / CTIS plain-language expectations
- Coordinating multi-stakeholder reviews within timelines
- Ensuring robust quality control and version management
- Content planning and outline proposal
- Drafting from CSR / protocol, supporting materials
- Incorporation of review comments
- Version management
- Final document preparation
- Contribution to terminology consistency, glossary, and readability
Benefits
- Opportunity to evolve through diverse projects
- Work alongside preeminent experts
- Environment that values natural talents
- Environment that pushes boundaries with audacity
- Environment that nurtures potential
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What This Job Offers
Job Type
Full-time
Career Level
Senior
