As a manager for the grants projects activities:
・Ensure and improve the process / system for supporting and managing the grants projects, which designed to meet with global / local SOPs, associated instructions, forms and guidance documents, global / local requirements, and regulations.
・Take responsibility as a secretariat office for running the current process / system properly and ensure process / system is in place to be able to oversight the proper spending and using
・Creating application requirements, public offering via the company internet website, hosting in-house review meeting, spending from the fund, collect the interim update reports, performing reconciliation, and closing the projects
As an approver for PubliRC:
・Establish PubliRC process as the standardized and endorsed in-house process and system for publication activities in Japan affiliate
・Improve the process / system, and manage the secretariat office for the PubliRC
activities for proper local publication activities
・Developing and improving a local SOP for PubliRC activities, managing the secretariat office, reviewing and approving drafts for the publication
As one of the delegated main approvers for LCC（資材審査部門）:
・Continuously propose and implement the improvement of LCC scope and process to adjust with local business situation e.g. number of originator and/or materials, trends increasing digital contents, and collaborate to evolve the in-house system for scalable review and approval.
・Review and approve the assigned type of communication materials in accordance with company policies, the code of standards for Promotional (sop-ai-008517) or
Educational (sop-ai-008518) or Press Communications (sop-ai-012672), and also Local SOP (sop-102204).
・B.A. or Master
・In depth knowledge and understanding of Medical Affairs tasks in the pharmaceutical industry and of applicable regulations and guideline, GVP/GMP principles, and practice. Able to apply theoretical knowledge in practical situations
・Familiarity with statistical principles and data analysis.
・Effective verbal and written communication skills. Action oriented. Should be able to adapt communication style to suit different audiences/cultures.
・Fosters a compliance culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
・Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
・High level of personal integrity with a strong commitment to medical compliance and ethical behavior.
・Fluent in written and spoken Japanese / English for business use
・Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
【就業時間】 フレックスタイム制 （フレキシブルタイム 6:00-22:00、コアタイム無し、一日当たりの所定労働時間は 7 時間 30 分）
Grant ProjectとMedical project management両方ができる希少なポジションです！Medical Operations Lead Japanの後任候補者となります。ご興味がございましたら、是非お早めにお問い合わせください！