Job Information
Cordis Medical Science Lead in Shanghai, China
概述
Job Profile and Position Summary:
Be responsible for medical and scientific data and information, product information, and disease areas communication with internal and external customers. Lead strategic decisions and develop clinical study plans and or alternate data collection pathways including coordination on IIS submission, review and feedback process; develop and maintain strong network and engage KOL through scientific interactions, gain valuable insights into existing knowledge gaps, scientific data gaps and clinical care gaps, and scientific activities in the therapeutic area and provide inputs to the company medical affairs strategy, plan, and business decision making. Support Professional education activities including but not limited to content review, HCP selection and or tiering process and any medical educational needs as directed.
The MSL will bring a background of scientific and compliance rigor, and excellent writing and communication skills. The MSL will be part of the Medical Affairs Department, and will report to Cordis Global Medical Director.
职责
Essential duties and responsibilities:
Develop an understanding of regional and national thought-leaders and the healthcare environments in which they work through effective professional engagement with Clinical and Scientific leaders that are centered on science and credible exchange of unbiased scientific information.
Interact with managed care organizations, healthcare professionals, clinical investigators, and other healthcare organizations providing fair, balanced, and scientifically rigorous medical and clinical information
Meet with healthcare professionals who might be interested in engaging in a scientific discussion regarding a product’s medical and clinical profile in the context of approved prescribing information as well as in response to unsolicited questions or requests for information which may involve off-label information. Lead the process of Investigator Initiated studies submission and approval process.
Identify and communicate key clinical and research insights from key opinion leaders to help formulate Cordis’ research and development strategies.
Lead execution of clinical studies and interface with regulators to clearly articulate the medical rational and data analysis as applicable
Develop and communicate in-depth clinical knowledge of the diseases of interest coronary artery disease (CAD) and peripheral vascular disease (PVD).
Establish relationships with opinion leaders , prominent academic and clinical investigators and leaders of medical and scientific organizations and assist with supporting relevant medical queries on approved products and or support new product development ideas as applicable
Educate healthcare professionals on the scientific safety and efficacy data for all of Cordis’ products.
Participate in informing relevant investigators regarding Cordis’ pipeline and research
Serve as a key inout to Professional education activities, speaker selection and /or tiering according to compliance guidelines
Upon request provide support for reimbursement dossiers and tendering activities.
Upon request, provide support for medical affairs activities such as advisory boards, key congresses and society meetings.
Assist in the development and deliver scientific training to field sales and other Cordis’ team members
Collaborate with company’s cross functions (incl. Complaint Handling, Quality & Regulatory Affairs) in facilitating medical safety evaluations and decisions.
Establishes and maintains good and effective working relationships with the Company’s Medical Director, clinicians, scientists, core-labs, clinical consultants, and internal clients.
Key role in compliance & ethics, maintains good relationships with internal and external compliance partners. Ensures a professional clinical approach which is in compliance with highest ethical and scientific standards in which patient safety and data accuracy are put first and considered as the highest goods.
Participates in the development, writing and review of clinical reports, for example clinical evaluation reports, periodical clinical updates, clinical justifications for regulatory filings, and slide presentations pertaining to Company’s clinical material.
资质
Essential qualifications:
Masters Degree or higher in clinical medicine or pharmacology or medicine relevant, MD, PhD preferred with a minimum of 5 years of relevant experience in a medical device industry
Understanding of clinical trial design principles, regulations and statistical rationale
Excellent oral presentation and written communication skills, medical writing experience preferred
Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders
Ability to initiate and maintain relationships throughout the medical community
Demonstrated ability to build positive constructive relationships with cross functional team members
Demonstrated high level of personal integrity, emotional intelligence, flexibility
Experience in relevant clinical practice a plus
Understanding of the highly regulated medical device industry environment in which we work
Ability and willingness to travel as needed
Understanding of the China legal and regulatory environment
Ability to assess clinical results summarize into reports, assist in authoring reports and justifications.
Operational processes, health care compliance, , regulatory requirements, as well as project management skills is required.
Extensive knowledge of GCP, GLP, and cFDA regulations.
Understanding of patient care cardiovascular and peripheral vascular procedures (especially Drug Coated balloon technologies)
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工作地点 CN-Shanghai
ID 2023-2310
类别 Clinical
类型 Regular Full-Time
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com