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 **Qualifications** 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: 1. Business level of Japanese and English communication 2. Interpersonal flexibility to effectively interact with a broad range of personnel in a cross-functional team environment. 3. Presentation skills and business acumen as a necessity 4. Demonstrated ability to analyze complex business situations and identify trends and creative business solutions. 5. Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide 6. Possess GLP competencies as Senior Leaders