Medical Affairs Manager

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Medical Affairs Group

Job Sub Function:
Medical Affairs

Job Category:
Scientific/Technology

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

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.

Key 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. 


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