Medical Writer

🕒 Julho 28

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Clario

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1973

🏥 Saúde

💼 Consultoria

📦 Logística

💰 Private Equity Round em 2019-10

Healthcare • Consulting • Logistics

A Clario é uma empresa especializada em acelerar ensaios clínicos desde a iniciação até a implementação por meio de tecnologias e serviços avançados. Desde 2018, a Clario tem revolucionado as análises de endpoints em ensaios clínicos, integrando mais de 30 soluções habilitadas por inteligência artificial em mais de 600 ensaios ativos, melhorando a qualidade dos dados e a privacidade dos pacientes enquanto acelera os processos de coleta de dados. A Clario oferece uma plataforma abrangente de gerenciamento de ensaios clínicos, oferecendo soluções como eCOA, segurança cardíaca, imagem médica, movimento de precisão e serviços respiratórios em várias áreas terapêuticas, incluindo oncologia, cardiologia e neurologia. Conhecida por seu alcance global, a Clario apoia ensaios clínicos em mais de 100 países com um forte foco em modelos de ensaios descentralizados e híbridos. O compromisso da empresa com a segurança do paciente e a inovação é refletido em mais de 26. 000 ensaios e participação em inúmeras aprovações de novos medicamentos.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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