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 Co

📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid