Medical Writer

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Clario

Site WebLinkedInTous les Emplois

5001 - 10000 employés

Fondée en 1973

🏥 Santé

💼 Conseil

📦 Logistique

💰 Private Equity Round en 2019-10

Healthcare • Consulting • Logistics

Clario est une entreprise spécialisée dans l'accélération des essais cliniques depuis leur lancement jusqu'à leur mise en œuvre grâce à des technologies et services avancés. Depuis 2018, Clario a révolutionné les analyses d'étape dans les essais cliniques en intégrant plus de 30 solutions équipées d'intelligence artificielle à travers plus de 600 essais actifs, améliorant la qualité des données et la confidentialité des patients tout en accélérant les processus de collecte de données. Clario propose une plateforme complète de gestion d'essais cliniques, offrant des solutions telles que eCOA, sécurité cardiaque, imagerie médicale, mouvements de précision et services respiratoires dans divers domaines thérapeutiques, dont l'oncologie, la cardiologie et la neurologie. Réputée pour sa portée mondiale, Clario soutient des essais cliniques dans plus de 100 pays, avec un fort accent sur les modèles d'essais décentralisés et hybrides. L'engagement de l'entreprise envers la sécurité des patients et l'innovation se reflète dans leurs plus de 26 000 essais et leur implication dans de nombreuses nouvelles approbations de médicaments.

Description

• Author, edit, proofread and finalise high-quality Expert Reports based on statistical outputs, study findings and scientific conclusions. • Partner with Statistical and Scientific teams to develop and maintain Statistical Analysis Plans (SAPs) for cardiac safety studies. • Ensure all written deliverables are scientifically accurate, clearly communicated and aligned with regulatory expectations. • Collaborate with internal stakeholders to interpret study data and effectively communicate results to sponsors. • Manage document timelines and priorities across multiple studies while maintaining exceptional quality standards. • Support the preparation of additional scientific and clinical study documentation as required. • Contribute to process improvements and best practices within scientific and medical writing activities. • Participate in client interactions and scientific discussions to support successful project delivery. • Partner with Statistical and Scientific teams to support sponsors in the development of study synopses, protocols and other clinical research documents related to cardiac safety. • Coordinate the timely delivery of Expert Reports, Statistical Analysis Plans and other key study outputs. • Maintain a strong understanding of FDA, EMA, ICH and other relevant regulatory guidance related to clinical trial reporting and documentation. • Stay current with developments in clinical research, cardiac safety assessment and scientific communication. • Support cross-functional initiatives within the broader Digital Physiology business.

🎯 Exigences

• Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Healthcare, or a related scientific discipline • Advanced degree (MSc, PhD or PharmD) preferred • Minimum 5 years' experience in medical, scientific or clinical writing within the pharmaceutical, biotechnology, CRO or clinical research sectors • Experience authoring scientific reports, statistical analysis plans, clinical study documentation and regulatory deliverables • Previous experience supporting Cardiology, Cardiac Safety, ECG analysis, electrophysiology or cardiovascular clinical trials is required • Strong understanding of clinical trials, ICH guidelines, and FDA and EMA regulatory requirements • Proven ability to interpret and communicate complex clinical and statistical data • Excellent written communication skills, attention to detail and document quality standards • Strong organisational and project management skills, with the ability to manage multiple priorities and deadlines • Experience collaborating with cross-functional teams, including statisticians, physicians and scientific experts • Proficient in Microsoft Office applications, particularly Word. • Able to work independently and effectively within a fast-paced global environment.

🏖️ Avantages

• Competitive compensation and incentive programmes • Private healthcare, pension and life assurance • Flexible working arrangements supporting work-life balance • Generous annual leave and wellbeing initiatives • Opportunities for professional growth within a global organisation • Access to collaborative global teams and innovative technologies • The opportunity to contribute to research that improves patient outcomes worldwide