Skills

Communication Research Literature review Organization Marketing

Job Specifications

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.

Position Summary

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.

Knowledge, Skills And Abilities Required

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.

Education

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.

Experience

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

Welcome to impact. Welcome to innovation. Welcome to your new life.

About the Company

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. At LivaNova, we understand the importance of bringing both clinical and economic value to our customers. We are a strong, market-leading medical technology and services company, offering a diver... Know more