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＜Position Summary＞

From investigational phase through post-marketed phase, take full accountability to provide functional expertise, leadership, support, and assistance to cross-functional teams and managements to achieve functional goals and objectives.

Implement safety risk management related activities from investigational phase through post-marketed phase including the preparation and implementation of risk management activities including aggregate reporting and safety measures of Janssen Japan portfolio and products such as risk assessment and risk minimization planning within responsible therapeutic area by liaising with J-PSC members, Safety Control Manager as appropriate to facilitate compliant, quality, timely and efficient safety risk management.

＜Responsibilities＞

Take full accountability to create, implement and verify J-RMP activities including EPPV, risk communication activities and aggregate reporting under GCP and GVP and all activities related to Clinical study.

Lead and facilitate J-PSC meeting in collaboration with JPKK’s key stakeholders.

As an extended member of Global Safety Management Team(G-SMT), liaise with G-SMT of responsible products/compounds. Join NPI and other related committee with license partner companies as a representative for J-PSC of responsible products/compounds and proactively lead safety risk management related discussions and take necessary actions by covering early stage of clinical development though post-marketed phase of products.

Lead and contribute to the prevention and rapid resolution of local safety risk management related issues including timely stake holder management (internal and external) of responsible products/compounds.

In all discussions including planning of safety measures and J-RMP, scientifically and logically discuss with a view to the final landing and conduct layer based stakeholder management base on the discussion, and facilitate the members to discuss from the same perspective.

Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with LT members.

Contribute to the implementation of continuous process improvements from advanced safety management point of view by utilizing latest technologies while enhance sustainable efficiency.

Understand and comply with the rule and principle of the relevant regulations such as PMD Act., GCP and GVP and ensure compliance to those regulations, within own responsibility.

＜Requirements＞

- Experience/Knowledge

8-year or more experiences in pharmaceutical industries are generally recommended.

Scientific & medical knowledge including local regulations, GCP and GVP.

- Skills/Capabilities

Must have strong leadership including decision making, management, negotiation, and stakeholder management and communication skills necessary.

Ability/competency to show contentious proposals to responsible teams and groups.

English communication skill (TOEIC 800 point and above), verbal, writing, presenting and facilitating.

Ability to demonstrate leadership skills per “J& J leadership standard” for “Directors and Managers”.

- Qualification/Certificate

BA degree in a biological or medically related field is preferred.

＜For Internal Applicants＞

Based on your experience and interview evaluation, the position title and level may vary.

If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.