※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] Medical Manager (Rare Disease)
[Salary] 8〜14 million JPY ※Experiences and skills will be considered
Job Scope: The purpose of the Medical Manager- Rare Disease position is to support the Rare Disease Medical Head to establish, implement, and execute on strategic objectives, operational and project budget planning and reviews, as well as coordination and project management of transversal projects, whether franchise/product-team specific or across teams. Within the Franchise assignment, specific responsibilities include, but are not limited to:
Lead and monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables.
- Communicate the details and progress of the Medical Plan to local Medical Team, the JPAC/ Global Medical and all parties responsible for execution.
- Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/ projects.
- Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.
- Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/ industry regulations.
- Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to local health authority).
- Review, approve and supervise all aspects of clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data.
- Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
- Lead the review and approval of the concepts/protocols of Post-Authorization Safety/Effectiveness Studies (PASS/PAES), Investigator Sponsored Study (ISS) and Diagnostic Testing Programs, according to applicable SOP(s).
- Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community.
- Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with JPAC Medical).
- Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
- Conduct situational analysis, lead/create a medical and cross functional plan, and execute activities that relates to newborn screening of lysosomal storage diseases and other rare disease related activities to improve disease diagnosis and patients` access to medications.
- 8-10 years. Relevant experience in Medical Affairs. MD/DO preferred. Doctorate (PhD, PharmD or advanced degree) with relevant experience.
- Excellent communication and presentation skills with the ability to present scientific data in a credible manner.
- Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena.
- Strong understanding of the pharmaceutical / biotech drug development and commercialization process.
- Leadership skills; personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances.
- Collaborative and proactive, with a hands-on, roll-up-the sleeves style and attitude.
- Highest integrity; committed to ethics and scientific standards.
- Working knowledge of English as a second language
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider