Perform Medical Affairs (MA) activities to maximize the value of compounds in the hematology field (Multiple Myeloma, B-cell lymphoma, Acute Myeloid Leukemia) and promote proper use. Analyze Unmet Medical Needs and Medical Gap and work with therapeutic area leaders to develop product strategies for each therapeutic area. Furthermore, create a medical affairs plan (MAP) that includes tactics.
Lead to successfully manage and execute the progress of each tactics in collaboration with relevant stakeholders such as therapeutic area leaders, Medical education, Medical affairs operations and MSL. Facilitates collaboration with regional/global counterparts and R&D.
It is preferable to meet all of 1 to 5. It is desirable that 6 has basic knowledge/experience that can be supported under appropriate guidance.
Lead/Support Identifying Medical Gaps and Developing Strategies for Evidence
Lead/Support development and execution of therapeutic area strategies and MAP for assigned compounds
Ensures timely and quality MA deliverables (e.g. medical education, advisory boards) as assigned and in alignment with MAP
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 publication, 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.
Communicate to regional/global MA and other functions on the implication of the study findings in a clear and effective manner
Clinical Research Activities:
Design and implement clinical research projects within defined standards and budgets (e.g. Phase IV, post marketing clinical activities such as registry/database projects, epidemiological surveys, etc.).
Provide the study-related documents (Protocols, management reports, etc.)
Provide the required oversight to manage review, approval and conduct of CSS/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)
Mandatory: At least 5 years of experience in a pharmaceutical company
・Experience of MA work at a pharmaceutical company
・Experience of R&D work at a pharmaceutical company
・Experience of clinical study related work and/or writing of papers at pharmaceutical companies or CROs
Essential Skills & Abilities:
Ph.D. is required. M.D. is preferred. Firmly grounded in the scientific fundamentals of experimental protocol development and methodology, data interpretation and scientific communication. Capable of implementing Medical Affairs tactics with oversight. Proven track record of strategic thinking, operational excellence and good communication skills.
Business level English communication skills (TOEIC ≥ 700 or equivalent) and Japanese skills
Cross-functional, smooth communication skills with a wide range of stakeholders in Japan and overseas
Knowledge of medical science and regulations – Required: Knowledge of each area of expertise required to perform Evidence Generation activities and ability to understand and comply with relevant laws and regulations.
Experience of clinical practice and basic research – Desirable
Project management skills: Skills to engage related parties in cross-functions and lead projects without delay
Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, J&J’s policies,“Our Credo ”, and procedures and accepted standards of best practice.
PC skills such as Word, Excel, Power Point, etc
・Master's degree or higher
・Ph.D. doctors in natural science: Firmly grounded in the scientific fundamentals of experimental protocol development and methodology, data interpretation and scientific communication.
A person who can proactively communicate with and engage with domestic and overseas stakeholders including KOLs.
A person with management skills who can demonstrate leadership and lead projects independently
Willingness to contribute not only to criticism but also to process improvement
Has the ability to solve problems and challenges with a wide range of ideas in complex business situations.
Have interest in and knowledge of Hematology (MM, B-Cell lymphoma, AML)
Primary Location Japan-Tokyo-To-Chiyoda-
Organization Janssen Pharmaceutical K.K. (7195)
Job Function R&D
Requisition ID 2105894977W