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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 :
1. 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.
2. 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.
3. 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).
4. 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
Valuing different backgrounds:
LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Notice to third party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
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