Medical Writer

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November 25

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LivaNova

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LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems.

1001 - 5000 employees

📋 Description

• Prepare clinical evaluation plans (CEP) and reports (CER), Post Market Clinical Follow-up (PMCF) Plans and Reports, and performs ad hoc and systematic literature reviews • Ensure completion of clinical evaluation plans (CEP) and reports (CER) and Post Market Clinical Follow-up (PMCF) Plans and Reports per each product family within the Cardiac Surgery (CS) franchise • Perform ad hoc and systematic literature reviews on global scientific newly released data to support Product Market Surveillance reports • Provide writing skills to protocols and clinical study reports and all relevant clinical documentation • Collaborate with cross-functional teams to develop clinical evaluation strategies

🎯 Requirements

• Minimum of 5 years of other relevant experience in areas such as medical or clinical research activities (eg, clinical trial management support, data management, submission dossier, Clinical Study Reports, etc.) • Previous experience in medical writing/reading • Understanding of the impact factor and relevance of scientific journals and papers • Strong skills in data statistics and study design • Industry experience that includes the understanding of Clinical Development, Regulatory Affairs and Marketing activities, through different stages • Understanding of the international guidelines, US and European • Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment • Efficient writing of large documents per project deadlines • Excellent English oral and written (C2); excellent oral communication and medical writing skills • Familiarity with industry-wide good publication practices • Minimum of Bachelor's (4 year university) degree. Graduate degree preferred. Biomedical or medical or pharmaceutical industry degree is preferred, or a strong expertise in medical device.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities