Key Responsibilities Include:

• Responsible and accountable for Medical Affairs strategy of therapeutic/disease area (TA/DA) including compounds/product development/business plan.

• Collaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall Medical Affairs strategy for product lifecycle aligned with company brand strategy.

• Responsible for people development and operational budget management of TA/DA group.

• Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC rules.

• Manage the high-performing organization and to provide the healthier working environment.

• Evaluating, developing and implementing training programs designed for further improvement of strategic capability by assessing needs, skills and scientific knowledge

• Providing advanced scientific information on Janssen products (incl. reactive off-label information) to HCPs in compliance with internal and external regulations

• Supervise all activities of each member in the group; Supervise to manage and utilize medical information for business; Supervise to handle inquiries from internal as well as external customers; Oversee the maintenance of product FAQ portfolio on Janssen products; Supervise providing appropriate information to relevant dept; Overseeing of Handling call center operation; Supervise reviewing materials to be distributed to external customers

• Driving functional excellence and alignment

• Managing operational TA budget and allocating human resources based on brand strategy and product life cycle

• Developing & managing TA strategy aligned with other critical functions/regions (R& D/BU/AP/GL); Supervision of Medical Affairs Plan (MAP)

Provides input into early development through core membership of TASTe; Assigning members for TA activities & product teams (JCoT, CVWG, IEGP etc ); Provides input into brand strategy

• Leading entire TA activities by providing clinical direction and strong leadership

• Accountability and supervision of MAP and monthly report by products

• Accountable for execution of all TA activities

• Collaborates with functional directors to improve the functional excellence and alignment

• Leading members in TA/DA departments

• Accomplishing TA objectives by establishing plans and KPI measurements with functional directors.

• Establishing good relationship with internal stakeholders (BU/R& D/AP; group level, individual issue or task oriented)

• Developing professional capabilities for TA departments including TA knowledge, data generation capability, and leadership.

• Managing TA/DA budget and human resources

• Managing operational budget and allocating human resources upon Medical Affairs plan

• In collaboration with finance controller and alignment with AP/GL MAF

• Managing MAF initiated clinical/non-clinical study

• Evaluating new IIS proposals

• Develop close relationship with Thought Leaders in the TA (TOP KOL Management)

• Developing KOL management plan with MSL team in collaboration with R& D/BU

• Maintains strong scientific collaborations with thought leaders within TAs to efficiently collect medical needs.

• Driving customer focus

• Accomplishing functional objectives by developing MAF plans

• Setting appropriate benchmarks and develop KPIs

• Tracking and evaluating functional activities with KPIs

• Developing the DA strategy aligned with the brand strategy under supervision of TA Director

• Creating Medical Affairs Plan in disease areas based on brand strategy under supervision of TA leader

• Gathering and analyzing the unmet medical needs from internal & external stakeholders

• Managing evidence generation / publication in align with brand strategy in a compliant manner of internal and external regulations

• Developing MAF study and publication plan aligned with brand strategy/IEGP

• Driving and executing MAF study in collaboration with KOLs and MAO

• Generating publications of MAF study collaborating with KOLs and MAO

• Day to day project management (lead) for MAF activities, report the progress to internal stakeholders

• Create a detailed work plan and determine the resources (time, budget, FTE etc) required.

• Develop a schedule for project completion that effectively allocates the resources to the activities

• Review the project schedule with the team affected by the project activities, revise the schedule as required.

• Monitor the progress of the project including budget management and make adjustments as necessary to ensure the successful completion of the project.

• Update to internal stakeholders in the company on the progress of the project.

• Review the quality of the project completed on a regular basis to ensure that it meets the project standard.

• Gathering and analyzing medical needs through communication with HCPs

• Gathering insights from HCPs and identifying new unmet medical needs

• Assessing medical needs/gaps in collaboration with TA department

• Analyzing medical needs and gaps based on inquiries and providing appropriate information to product strategy

• Support MR medical knowledge trainings in collaboration with SL& T

• MSL activities

• Leading MSL group members

• Accomplishing group objectives by establishing plans (MSL activity and KOL engagement) and KPI measurements with functional directors

• Managing operational budget and allocating human resources upon Medical Affairs plan

• Establishing good relationship with internal stakeholders (BU/R& D; group level, individual issue or task oriented)

• Developing professional capability for MSL (including TA knowledge, leadership and people management skills)

• E2E execute MAF studies in collaboration with TA and MAO

• Developing strong relationship with KOLs in collaboration with TA (lead) and internal stakeholders (KOL Engagement)

• Developing the KOL engagement plan aligned with Medical Affairs strategy

• Executing scientific communications effectively with KOLs based on KOL engagement plans

• Managing scientific knowledge and medical information

• Collecting and analyzing scientific knowledge and medical information (incl. scientific competitive intelligence)

• Disseminating the analyzed scientific knowledge and medical information to internal stakeholders (scientific slide set, congress analytical report, evidence book, product FAQs, and reply to inquiries)

• Secure scientific quality of medical and promotional materials the company issues through review processes from scientific/medical points of view

• providing the analyzed scientific knowledge and medical information to internal stakeholders (scientific slide set, congress analytical report, evidence book, product FAQs, and reply to inquiries)

• Responding to customer inquiries escalated by internal stakeholders.

• Conduct training sessions for staffs so that they can gain optimal use from the Information Services. These sessions should focus on accessing the information, feeding back local information into a central database, and the importance of timely and accurate delivery of information as a competitive advantage.

• Supervise handling inquiries from external customers

• Handling medical information center operation under supervision of MIC Group Manager

• Creating and maintaining of product QA section on Janssen website

• Planning MAF organizational strategy and support functional excellence and alignment with tracking KPIs

• Support MAF head for planning MAF strategy

• Implementing and analyzing the KPIs with functional directors

• Conduct internal Medical Affairs Event (e.g. Town hall meeting)

• Support managing operational division budget and allocating human resources based on TA strategy and product life cycle

• Assigning member for record coordinator of Medical Affairs

• Oversee managing and filing the all contracts in Medical Affairs

• Supervise managing the databases (CTMS/TMS) and support management of trial master files

• Supervise a role of secretariat

• Supervise monitoring changes in local regulations related Medical Affairs activities

• Ensure Medical Affairs SOP in place and updated to reflect any changes in local regulations as well as any changes in regional / global policies

• Managing MAF initiated clinical/non-clinical study operation

• Providing advanced scientific information on Janssen products (incl. reactive off-label information) to HCPs in compliance with internal and external regulations

EXTERNAL AND INTERNAL INTERACTIONS

The role involves extensive interactions with:

• Domestic and international KOLs in responsible therapeutic area.

• Regional leadership team

• Other local management board members

• Sales and Marketing leaders in JPKK

• R& D, PV, PMS and Regulatory Affairs leaders in JPKK

• All Medical Affairs leaders and members Qualification:

• MD, PhD, MBA is desirable
• Work experience of 2-3 years as a people manager in MA, R& D, and MKT of pharmaceutical industry.
• Work experience of 3-5 years in specific TA is preferred.
• Deep understanding of local regulatory policy and industry's code of practice related to drug registration, pharmaceutical promotion and clinical study is preferred
• Understanding on operations and execution of clinical studies is preferred.

Competency Requirements:

• Integrity and adherence to Johnson & Johnson Credo values.
• Collaboration, strategic thinking, and attention to detail.
• Strong communication skills in Japanese and English, with the ability to interact across functions.
• Advanced analysis of complex business situations and trends.

LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED:

Business level of Japanese and English communication

Interpersonal flexibility to effectively interact with a broad range of personnel in a cross-functional team environment.

Presentation skills and business acumen as a necessity

Demonstrated ability to analyze complex business situations and identify trends and creative business solutions.

Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide

Possess GLP competencies as Senior Leaders