17 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:
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 .
- Contribute to medical review of clinic
📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid