Medical Affairs Manager, Neurovascular Japan

POSITION SUMMARY: 

The purpose of the position is to strategically provide medical supervision, support business activities, evidence generation/dissemination, educational activities and engage with internal/external stakeholders. Leading with an outside-in vision to assimilate opportunities identifying market unmet needs, this role provides medical/scientific insights. Additionally, this position has a role as an SRP (study responsible physician) for clinical studies. 

Essential / Principal duties and responsibilities: 

• Medical Governance: To ensure health care compliance on promotional material and health care professional qualification in accordance with J&J policy, company GOP/SOP and related working procedure. To ensure the contents and medical claim in following parts, including Indication, contraindication potential complications, clinical trial related contents, caution/precaution and adverse event are accurate, fair and objective. 

• SRP (Study Responsible Physician): To be responsible for performing safety review and making a recommendation about continuation or termination of clinical trials based on medical expertise. Play a role of the study safety lead as a medical doctor. 

• Safety Vigilance: To work with vigilance safety members as a team to ensure that the information regarding adverse events in the field, facilitate an accurate and transparent communication on adverse events and complaints internally and properly review them. 

• To assess device performance including clinical benefits and safety profiles. Evaluate the appropriate risk-benefit balance to support market registration and throughout life cycle. 

• MIR: To provide scientific and medical information to internal stakeholders and external customers, including unsolicited requests from healthcare professionals to ensure clinically appropriate and safe use of company products. 

• To collect the Investigator Initiated Study (IIS) ideas/proposals for research grant, ensuring that specific evidence needs are assessed through medical science liaison and the proposals are discussed within local or global internal committees collaborating with clinical affairs members. Regarding non-clinical studies, coordinate and track the progress on contract, execution and publication for studies.   

•  For clinical studies, to provide medical insights on clinical question and study design, address the inquiries in internal committees, review manuscripts and provide timely feedback to the study team. 

• To plan non-clinical studies internally for local evidence generation. Coordinate internal committee approval process to execute them collaborating with external investigators. Coordinate contract, execution and publication for studies. 

• In accordance with the company strategy, to engage with external stakeholders by medical science liaison. Build and maintain professional relationships with external experts to gain understanding, insights, and opinions on treatment patterns, including scientific activities and healthcare professionals needs within disease areas.  

• To work with cross-functional partners, providing strategic clinical/medical support for evidence activities related to the conducting clinical studies (e.g. protocol preparation, safety review, study report writing and publication). Maintain scientific contacts with local investigators. Provide medical strategic plans and solutions to support business team on product and/or procedure management for related therapeutic area in terms of evidence generation/dissemination and other related activities. 

• To support educational activities for internal or external stakeholders, 

• To input into risk management processes for hazard/harm identification & risk mitigation in cross functional team. 

• To develop an understanding SOPs and proper working instructions to ensure the internal process follow company policy and related regulation if applicable. 

• Initiative/support for publication of developed evidence.  

Education and Experience Requirements:

• M.D. or D.D.S. (mandatory) with Ph.D. (preferable)
• Preferably a Neurointerventionalist/Neurosurgeon

Required:

• Business level of English communication skills
• Deep clinical and medical knowledge in certain disease areas

Preferred:

• Experience/expertise in scientific/medical/clinical research.
• Medical doctor (MD) with Neurovascular experience.

Other:

• Proficient in the English and Japanese languages.
• Ability to communicate effectively with external and internal stakeholders across the world based on medical and scientific expertise.