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As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. The Medical Writer prepares clinical evaluation plans (CEP) and reports (CER), Post Market Clinical Follow-up (PMCF) Plans and Reports, and performs ad hoc and systematic literature reviews.
Job Responsibility:
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 in cooperation with all main internal and external stakeholders within the agreed timelines
Perform ad hoc and systematic literature reviews on global scientific newly released data to support Product Market Surveillance reports, Global Signal Detection meetings, Study Design Protocols, Global Market Value Dossiers, Regulatory Dossiers, Medical Affairs scientific summary documents
Provide writing skills to protocols and clinical study reports and all relevant clinical documentation (literature review plans/reports
study protocols/reports
scientific manuscript
congress abstracts/posters/presentations)
Collaborate with cross-functional teams to develop clinical evaluation strategies
Requirements:
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
Ability to work well with a diverse group of personalities, team player, flexible and adaptable
ability to build relationships, both internally and externally to the organization
Excellent English oral and written (C2)
excellent oral communication and medical writing skills
Familiarity with industry-wide good publication practices
Minimum of Bachelors (4 year university) degree
Graduate degree preferred
Biomedical or medical or pharmaceutical industry degree is preferred, or a strong expertise in medical device
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.)
Willingness to travel: up to 25% of the job may be travel