Tokyo,10.0M ～ 13.0M

Essential Job Functions/Duties:
- Develop and execute an annual medical education plan for the assigned specialties and geography, in partnership with Medical Education, Division & Marketing leadership/stakeholders based on current and future product portfolio and procedural trends.

- Collaborate with relevant Divisional & Marketing stakeholders and resources to develop content to support educational programs with appropriate messaging that meets customer and company needs, as well as compliance and regulatory standards.

- Develop, implement, and maintain policies, procedures, criteria, and qualifications for attendees, programs, and divisional representatives.

- Responsible for annual budget projections and tracking of activities for medical education training programs.

- Review, approve, and manage the calendar of educational events to ensure structure and alignment with Medical Education and divisional goals.

- Identify HCP consultant partners that support education initiatives in collaboration with division stakeholders. Work closely and maintain regular communication with identified HCP consultants on all initiatives while maintaining compliance and legal standards.

- Coordinate and support the implementation of medical education training programs, providing an overview of training course goals and learning objectives, course criteria, and processes as part of a needs assessment for customer programs.

- Continuously evaluate and improve the strategy for Medical Education by monitoring metrics and listening to feedback from customers and employees. Take action and resolve issues and gaps quickly and effectively.

- Report transparently and timely to Medical Education leadership.

- Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc., in a timely manner.

- Willingness and availability to travel on company business.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.

- Within the scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.

- Demonstrate a clear understanding of and adherence to compliance and legal standards and regulatory processes relative to technical and procedural education delivery and materials.

- Understand and be accountable for conducting business with integrity and in compliance with applicable standards, including the company's policies.

- Maintain our culture, values, and commitment to Ethics and Compliance by recognizing, demonstrating, and enforcing appropriate and compliant behavior.

Tokyo,Osaka,10.0M ～ 12.0M

Job Description
Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.

Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.

Skill-set
- Excellent Communication and relationship building skills
- Proven ability to prioritize and manage multiple tasks with conflicting deadlines
- Excellent interpersonal skills and proven ability to facilitate team building and team work
- Proactively identifies risks and issues and possible solutions
- Demonstrates ability to prepare and deliver study related training materials
- Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
- Demonstrates professionalism and mutual respect
- Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
- Proven learning agility
- Basic knowledge and experience of quality management

Nice to have
- Project management certification
- Ability to interact widely and effectively within the company at all levels. Good networking skills
- In-depth knowledge of clinical and drug development process
- Fiscal and financial awareness

Tokyo,Osaka,10.0M ～ 14.3M

Leads the creation of the strategic global medical plan for Pharma Therapeutic Area product, in alignment with the countries’ medical planning and in alignment with the global business function and other internal stakeholders

Executes some strategically important parts of the global medical plans, like KOL relationship management activities

Oversees and monitors the execution of the global medical plans

Contributes to / provide the medical strategy for global Phase IV medical affairs studies to support the commercial success of our Pharma Therapeutic Area products

Plans and coordinates the design, conduct, analysis, reporting and publication of Phase IV Studies

Contributes to / Provides the strategic review of our Pharma Therapeutic Area ISS and NIS studies

Provides medical affairs input to global clinical development programs

Ensures all regional studies are consistent with agreed medical strategy

Oversees and monitors the long-term communication plans; this includes the long term medical affairs study and data generation plans

Interprets information from clinical development studies, medical affairs studies, and from external sources, to generate communication materials and documents for internal and external use, including slide decks, training material, Q&As and others

Leads the Global Content Network for medical information document generation. Updates, organizes and maintains the global medical information documents within the proprietary repository

Provide Medical review of promotional material from the GBT for global use e.g. product monographs, brochures, press releases, Q&As, field communications

Contributes to the Global Brand Team’s work by providing medical expertise and insight on commercial issues

Provides Medical Affairs input to core labeling and pharmacovigilance documents for marketed products

Ensures excellence in medical governance activities, including the collaboration with co-development partner companies

Establishes professional relationships with global clinical investigators, opinion leaders, and consultants in the medical community

Represents our company's viewpoint on products to key opinion leaders, scientific advisors, health authorities and to other external stakeholders

Plans and monitors the global medical affairs budget, in collaboration with the global business function and our external co-development partners

Maintains and develops relationships with scientific communications agencies, clinical research organizations, and other service providers as required to support excellence in global launch and post-launch medical affairs operations