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 o

📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid