Medical Writer

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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