10 ago
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Jobgether
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España
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior/Principal Medical Writer based in Spain.
Join a specialized medical writing team supporting the development of high-quality regulatory documentation for the integral pharmaceutical industry. In this role, you will contribute to clinical development programs across multiple therapeutic areas, partnering with scientific teams and industry stakeholders. You will take ownership of complex regulatory documents while combining scientific expertise, writing excellence, and project coordination skills. This position offers the opportunity to make a meaningful impact on healthcare innovation while working in a collaborative, remote environment. You will have the autonomy to lead projects, share expertise, and grow within a team focused on quality, precision, and scientific communication.
Accountabilities
- Lead the preparation of complex clinical and regulatory documents, including Clinical Study Protocols, Clinical Study Reports,
Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications.
- Collaborate with clinical development teams, subject matter experts, and stakeholders to produce accurate, compliant, and scientifically robust documentation.
- Provide document-specific guidance and strategic writing support to clients and project teams.
- Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.
- Coordinate and oversee contributions from other medical writers, quality control specialists, and supporting team members.
- Monitor project budgets, follow internal procedures, and ensure successful delivery within agreed timelines.
- Work effectively within client regulatory document management systems and maintain high standards of documentation practices.
- Act as a trusted partner throughout the clinical development proc
📌 Senior/Principal Medical Writer (España)
🏢 Jobgether
📍 España