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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 :
- 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 manuscripts; 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 understanding of Clinical Development, Regulatory Affairs, and Marketing activities through different stages. Understanding of 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, be a team player, flexible and adaptable; ability to build relationships, both internally and externally to the organization.
- Excellent English oral and written communication (C2); excellent oral communication and medical writing skills.
- Familiarity with industry-wide good publication practices.
Education :
- Minimum of Bachelor’s (4-year university) degree. Graduate degree preferred.
- Biomedical, medical, or pharmaceutical industry degree is preferred, or strong expertise in medical devices.
Experience :
- Minimum of 5 years of relevant experience in medical or clinical research activities (e.g., clinical trial management support, data management, submission dossiers, Clinical Study Reports, etc.)
- Willingness to travel: up to 25% of the job may involve travel.
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 key demands/requirements for the role rather than bias or discrimination based on sex, gender identity, age, marital status, veteran status, disability, family status, sexual orientation, religion, ethnicity, race, or any other protected classification.
Notice to third-party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. Without a signed Recruitment Services Agreement, we will not consider or pay referral fees. Submissions without an agreement may be pursued and hired without obligation.
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Be cautious of fraudulent postings or suspicious activity by individuals posing as LivaNova recruiters. We will never ask for fees or banking information during the application process. Verify any suspicious offers by searching for “See Open Jobs” and ensure recruitment emails come from an @livanova.com address.
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