北京招聘

职位描述：
Medical issues
Is responsible for medical issue resolution understood as:
o Significant medical issues
？ Potential/actual critical medical qualifying quality issues
？ Complex safety issues
？ Corrective And Preventive Actions
o Other medical issues
？ Reactive medical support to facilitate ethics/regulatory approvals
？ Medical questions from investigator/monitor
？ Protocol Deviations with potential medical/safety implications
？ Addressing unusual data for major endpoints or for safety
？ Study interruption relating to benefit/risk
？ Review of study documents / translations only upon request due to significant changes to medical wording
？ Helping investigators to understand how patients in their medical practice can be recruited ie. align with protocol inclusion/exclusion criteria

Training (high risk studies)
? Attends investigator meetings of the protocols he/she is responsible for when possible
? Address specific investigator knowledge gaps during site visit
? Provide the retraining associated with significant medical site quality issues (e.g. as part of site based Corrective and Preventive Activities), ensuring investigators are engaged with the protocol and understand the importance of quality and rigour in collection of key data supporting the integrity of the study
? Site initiation visits when associated with a specific need to address risk to quality / patient safety
Site Visits/contact with sites
Targeted site visit (or other contact forms as needed) to address specific medical issue or need (high risk studies – but also for all studies for critical medical issue)
o Follow up on Serious Adverse Events to enable clear narrative
o Potential / actual Qualifying Quality Issues
o Protocol Deviations and/or Site Visit findings with potential medical impact
o Identified specific investigator re-training need
o Accompany auditor on targeted audit where specific medical expertise is required
o Other (e.g. need for medical review of patient notes, audit findings)
? Proactive site visit (or other contact forms as needed) based on the relevant risk factors identified to address potential site based risk (high risk studies)
o When consistent with specific risk mitigation plans
o Ideally conducted in conjunction with site monitor


Qualifications (Training, Education & Prior Experience):
Education
? The RMM must have a medical degree (MD or equivalent) and professional qualification from a recognized medical school, she/he must have training in ICH/GCP principles and in global and local policies relevant to the role (e.g. SOPs).
Experience
? Required: Be licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post “intern/houseman” year) and utilized that license to prescribe medicines in a patient care setting for an aggregate duration of at least one year, and always been in good standing with his/her licensing Health Authority. Experience in Phase 2 - 4 clinical development in the pharmaceutical industry and/or at a CRO, or in clinical / academic practice, including practical experience in clinical trial strategies, methods and processes.
? Preferred: Experience in regulatory audits.
Skills
? Deep knowledge of clinical development, principles of ICH/GCP, and experience in the management and reporting of adverse events (AEs) and serious AEs (SAEs).
? Thorough knowledge of local (and where appropriate) international regulations applicable to clinical development including Ethics Committees’ standards. Practical knowledge of clinical trial strategies, methods and processes.
? Be able to use various global computer system tools to facilitate medical oversight of clinical trials
Competencies
? Clinical trial expertise
o Expert in full drug development processes from phase I to IV
o Extensive medical knowledge and AE/SAE expertise
o Good relationship with a wide network of Key Opinion Leaders in different therapeutic areas
o Thorough knowledge of the company direction, investigational product(s) and its development plan, the protocol, applicable SOPs, GCP, data privacy laws
o Demonstrated potential or ability to initiate and conduct clinical studies in industry, academic, or research clinic setting
o Knowledge of the conduct of regulatory audits and requirements
o Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents
o Deep knowledge of region, culture, patient populations, specific Therapeutic Area nuances/standard practices of medicine within the region
? Medical skills and Scientific excellence
Understanding of the complexities and recent developments in the relevant therapeutic/ technical area, and the ability to apply such knowledge to drug development
? Presentation and analytical skills
o Strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data
o Speaks and writes English fluently 举报 分享

西藏晨泰医药科技有限公司成立与2017年1月，在上海、北京有办公室，目前主要从事肿瘤药物开发。