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 .
- 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 . ✨ Why join Crovelis? 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. ? Not the right opportunity for you? Follow Crovelis on LinkedIn and Instagram to stay up to date with our latest career opportunities. #Crovelis #Hiring #ClinicalDevelopment #MedicalWriting #MedicalMonitoring #ClinicalResearch #Pharma #Biotech #CRO #LifeSciences #DrugDevelopment #Pharmacovigilance #Talent

📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid