Join us today and make a difference in people's lives!
Clinical Evaluation Manager / Medical Writer Manager (m/f/d)
Essential Job Functions
- 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
- 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
- Manage a small team of internal and external medical writers
- Manage the medical writing project schedule and deadlines
- Provide strategic decisions on projects in the medical writing program
Knowledge, Skills and Abilities Required
- Minimum of bachelor’s degree; graduate degree preferred
- Biomedical or medical or pharmaceutical industry degree is preferred, or a strong expertise in medical device
- Several years of other relevant experience in areas such as medical or clinical research activities (e.g., 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
- 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
- Team leading experience or project management experience
- Excellent English oral and written (C2); excellent oral communication and medical writing skills
- Familiarity with industry-wide good publication practices
What we can offer you
In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:
- A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
- Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians
- Competitive base salary
- Variable short-term & long-term incentives
- Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements
If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!
Our commitment to Diversity & Inclusion:
LivaNova values equality and celebrates 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.
Beware of Job Scams:
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.
