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 clinical data ahead of

database lock .

Support the preparation and review of

DSURs, safety reports , and regulatory documentation.

What are we looking for? We are looking for a

scientifically strong, autonomous, and versatile professional

who can combine medical expertise, scientific rigor, and excellent communication skills.

Key requirements:

MD, PharmD, PhD , or equivalent advanced degree in Life Sciences.

3+ years of experience

in Clinical Research, Pharma, Biotech, or CRO environments.

Demonstrated experience in

Medical Writing and Medical Monitoring .

Fluent in

English and Spanish .

Strong knowledge of

ICH-GCP, FDA, and EMA

requirements.

Experience in clinical development and clinical trial methodology.

Knowledge of

drug safety and pharmacovigilance .

Ability to critically assess and interpret complex clinical and safety data.

Excellent scientific writing and communication skills.

Strong organisational and project management skills.

Ability to thrive in an

international, cross-functional environment .

A

proactive, analytical, and problem-solving mindset .

This is an opportunity to play an active role in

clinical development , collaborate with multidisciplinary teams, and contribute to projects that support the development of new therapies.

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Crovelis

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📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid