Medical Writer (Madrid)

Medical Writer (Madrid)

02 oct
|
Crovelis
|
Madrid

02 oct

Crovelis

Madrid

We’re Hiring: Medical Writer & Medical Monitor
Are you passionate about clinical development and looking for a role where you can combine medical writing, medical monitoring, and scientific expertise?

At Crovelis, we are looking for a Medical Writer & Medical Monitor to join our team and play a key role across our clinical development programmes and studies.

? This is a unique opportunity to combine two key areas:
✍️ Medical Writing | ? Medical Monitoring
You will work closely with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and external investigators, contributing to both the scientific quality of clinical documentation and the medical oversight of clinical trials.

What will you be doing?
As a Medical Writer, you will:
• Draft, review, and maintain key clinical and regulatory documentation.
• Contribute to Clinical Study Protocols, Protocol Amendments, Investigator’s Brochures, Clinical Study Reports, and Informed Consent Forms.
• Prepare safety narratives and support regulatory submission documents.




• Contribute to development plans, briefing documents, and responses to regulatory authorities.
• Support the preparation of scientific publications, abstracts, posters, and manuscripts.
• Coordinate cross-functional document reviews and ensure scientific accuracy, consistency, and compliance with applicable regulations.

As a Medical Monitor, you will:
• Provide ongoing medical oversight for assigned clinical studies.
• Act as a medical point of contact for investigators and clinical sites.
• Review safety data, including AEs, SAEs, AESIs, laboratory results, ECGs, and other clinically relevant findings.
• Collaborate with Pharmacovigilance teams on the identification and assessment of safety signals.
• Review protocol deviations and assess their potential impact on patient safety and study integrity.
• Participate in Data Review Meetings, Safety Review Committees, and, where applicable, Data Monitoring Committees.
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📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid

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