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Field Clinical Senior Specialist CV, Japan - Chiyoda City, 日本 - LivaNova PLC
4日前
説明
Join us today and make a difference in people's lives
・Prepare and provide effective training programs both for LivaNova CP sales team and customers
・Assess the findings through the scientific/clinical study and support Marketing team how to use the findings in order to develop sound strategies to promote LivaNova products
・Support new product launch collaboratiing with Marketing
・Support JaSECT and other related medical congresses, then strengthen the relationship with LivaNova
・Support training/education activities led by JaSECT and other medical congresses
・Preparatory work for opening LivaNova Training/Education Center
・Design and drive scientific/clinical studies to demonstrate clinical benefits of LivaNova perfusion system
Promote strategically important concept and support customers to conduct scientific study to prove its clinical effectiveness/value, such as;
-GDP
-GME
-Irrelevancy between pressure drop and hemolysis
・Support and work with perfusionists to accelerate the execution of above studies
・Support Training and Educational initiatives of JaSECT
・Work with overseas KOLs and introduce the updated information and innovative ideas to Japanese customers
・Establish training programs and design its execution plan
・Deeply communicate with BU Marketing and Clinical team to get valuable information in overseas markets and get more support for Japanese Study/Training initiatives
・Plan and execute P2P events in collaboration with marketing
・Design training center (facility and location) and training program
・Support sales team promotion activities with deeper product/clinical knowledge
Medical Expert PDP and Compliance Activities
• Consult on defining clinical/user needs for product development inputs
• Provide expert input on Clinical Strategy and study design
• Clinical evaluation and post-market follow-up planning/reporting. Reviewer and approver.
• Promotional material reviewer and approver
• Consult on providing evidence for promotional claims/ claims matrices
• Risk documents (including harms, severity, occurrence) consultant, reviewer, and approver
• PMS Complaint reviewer
• Clinical study report reviewer and approver
• Clinical Analysis Report (for PMCF clinical activities) reviewer and approver
• Training of internal colleagues involved in product development and compliance activities
• Consult on clinical/medical questions coming from regulators
• Clinical Assessment for adverse events
Requirements for Clinical evaluation medical expert approver:
•Knowledge of EU-MDR
•Should have at least the following training and experience in the relevant field: a degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.
•Knowledge of: Diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).
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, and check that all recruitment emails come from an email address.
