※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Reporting to the Medical Affairs Manager, Medical Affairs Dermatology, this position represents the affiliate's medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas. The position provides medical expert advice / guidance to key internal and external customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with external experts. It provides medical endorsement and medical input into marketing strategy and key commercial initiatives, as required, and medical support for medical department activities under the direction of the Medical Affairs Manager, Medical Affairs Dermatology.
■Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature.
■Provide expert medical advice for assigned products and related therapeutic areas, including responding to requests for scientific/technical information; contribute to the development, medical and scientific accuracy of core dossiers generated by the medical department.
■Establish and maintain professional and credible relationships with external experts and academic centers; this will involve participating in scientific congresses, coordinating advisory boards, round-table meetings, discussion forums, etc.
■Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups (meetings, clinical sessions, etc.), where requested. Develop and update medical education materials.
■Screen relevant literature and other information from relevant scientific societies meetings and conferences and develop summaries of key messages for use within the Company (e.g. key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc.)
■Contribute medically to the training for sales forces and other departments; develop and update relevant training materials.
■Medical Research Activities:
- Design and implement Medical research projects within defined standards and budgets (e.g. Phase IV, post marketing clinical activities such as registry/database projects, epidemiological surveys, and PMOS studies).
- Provide the required oversight to manage review, approval and conduct of IIS studies.
- Support the affiliate Clinical Research Department in the management of clinical studies, as appropriate (e.g. review new clinical study protocols, identifying potential investigators/sites, conducting feasibility surveys).
■Review and preparation of promotional material. Ensure the medical/scientific content is correct and fully compliant with company's internal policies and guidelines.
■Provide medical input into marketing strategy and key commercial initiatives, as required. Monitor the environment for competitive intelligence (e.g. product strategies, studies, commercial messages, positioning, etc.) and communicate, where appropriate, within the Company.
■Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, company's policies and procedures and accepted standards of best practice.
- Medical Doctorate (M.D.) and Ph.D. in Dermatology with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess excellent oral and written English communication skills.
※Experiences and skills will be considered
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