Basic purpose of the job
To contribute to execute CDMA activities in Japan according to TA strategy between start of preclinical development and late stages of commercialization
・Contribution to CDPs after proof of concept and late stages of commercialization.
・Prepare Integrated Customer Plan ＆ Detailed Annual Communication Plan to address Japan specific needs, together with Marketing and Market Access ＆ aligned with global IBP
・Build new scientific evidence by collaboration with external experts through clinical/pre－clinical researches, investigator initiated studies and RWE studies.
・Contribution to benefit/risk evaluations of products.
・Gain insight from external expert with MSL and propose medical strategy.
Regulatory and / or Organisational Requirements
Contribute to Strategy and Activity Review Committee meetings. Ensure ethics and compliance. Ensure re－examination by reviewing documents and process. Plan strategically to allow for effective, safe ＆ medically sound global preparation of drug commercialization efforts. Provide input and medical review of all in－ and external documentation prepared by Marketing and Public Relations. Define trials needed to answer relevant questions regarding the company's products and their related development projects to meet regulatory and payer requirements and the company commercial needs build upon from the trials concepts developed by the MST＆LPT. Provide medical input into epidemiology studies. Ensure communication with CPL. Support to obtain preferable pricing.
Full understandings of regulatory and compliance requirement in Medical Affairs
Minimum Education/Degree Requirements
Master of Science
Required Capabilities （Skills, Experience, Competencies）
・TA experience in clinical or research setting, ideally for heart failure and chronic kidney disease.
・Strong negotiation and communication.