Medical Writer I ensuring data integrity and quality checks for clinical documents in a biopharmaceutical company. Collaborating with medical writing teams and participating in stakeholder meetings.
About the role
- Medical Writer creating impactful documentation for clinical studies and regulatory submissions. Collaborating with internal teams and ensuring clarity and compliance in scientific communications.
Responsibilities
- **Main Responsibilities:**
- Perform scientific literature surveillance in bibliographic databases, including search strategy development, publication selection, and critical analysis
- Compile relevant information into structured state-of-the-art sections covering the targeted pathology, therapeutic alternatives, and standard of care
- Contribute to CE marking submissions and renewals
- Draft and/or update Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), including critical appraisal of relevant clinical data in accordance with applicable guidelines
- Support Post-Market Clinical Follow-up activities (PMCF Plans and PMCF Reports)
- Collaborate closely with internal teams such as Regulatory Affairs and R&D/Engineering (clinical justifications to Notified Bodies, risk analyses, co-authoring of technical documentation)
- Contribute to the scientific valorization and dissemination of knowledge related to company products
Requirements
- **About You**
- We are looking for passionate professionals who are committed to delivering excellence and have a strong aptitude for scientific communication:
- **Education:** Degree in life sciences (MSc, Engineering degree, or equivalent), ideally complemented by specialization in clinical evaluation
- **Experience:** Experience in drafting Clinical Evaluation Reports under MEDDEV 2.7/1 rev.4 or EU Medical Device Regulation (EU MDR 2017/745)
- **Skills:** Strong understanding of clinical research processes and regulatory requirements.
- Excellent writing, editing, and organizational skills with meticulous attention to detail.
- Proficiency in Microsoft Office Suite and literature databases.
- **Languages:** Proficient in English (written and spoken); additional languages are a plus.
Benefits
- **Why Join Us? **
- At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- Here's what makes us unique—
- We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's **leading mid-size CRO **with the **best employee experience**. Our **one-stop provider service model**—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
- **Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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