Senior Medical Writer
il y a 6 jours
**Why Join Us?**
At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.
As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's **leading mid-size CRO**, delivering the **best employee experience**. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.
**About the Job**
We are seeking a Senior Medical Writer to produce medical writing deliverables (both regulatory and medical communication documents).
**Main Activities**:
- Ensure compliance with sponsors’ and Excelya’s SOPs, guidelines, and relevant legislation.
- Stay updated on changes in industry standards, laws, and procedures.
- Conduct literature reviews aligned with project and sponsor requirements.
- Write, edit, and review a wide range of medical documents (protocols, CSRs, ICFs, CTDs, manuscripts, etc.).
- Perform quality control for accuracy, consistency, and compliance with industry standards.
- Review statistical analysis plans, tables, and figures for clarity and correctness.
- Collaborate with cross-functional teams (data management, biostatistics, project management) to ensure timely and high-quality deliverables.
- Communicate with sponsors to manage document expectations and negotiate changes.
- Mentor and support junior and senior medical writers; act as backup when needed.
- Contribute to project coordination and assist other Medical Affairs team members as required.
**Requirements**:
**About You**
- Master degree in life sciences or equivalent
- A relative experience of a minimum of 3 years in medical writing.
- Has previous experience working a CRO
- Analytical skills and ability to interpret data
- A strong work ethic
- Intellectual curiosity and creativity
- The ability to work effectively in a team in a fast-paced and dynamic environment
- Advanced level of English
- Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines
**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.
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