[Janssen] Medical Affairs TA (Therapeutic Area) Specialist -Manager Pulmonary Hypertension-

POSITION SUMMARY ・Responsible to develop the Medical Affairs product strategy through the analysis of medical needs collected from all internal & external stakeholders of the therapeutic area ・Responsible for managing MAF study / publication portfolio in alignment with brand strategy ・Responsible for people and operational budget management of PH (Pulmonary Hypertension) therapeutic area ・Day to day project management for activities based on the Medical Affairs Plan in responsible disease areas ・Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC (Healthcare Compliance) rules. Driving functional excellence and alignment Driving customer focus -Accomplishing functional objectives by developing MAF (Medical Affairs) plans -Setting appropriate benchmarks and develop KPIs -Tracking and evaluating functional activities with KPIs Leading entire TA activities by providing clinical direction and strong leadership -Accountability and supervision of MAP (Medical Affairs Plan) and monthly report by products -Accountable for execution of all TA activities -Collaborates with functional directors to improve the functional excellence and alignment Develop close relationship with Thought Leaders in the TA (TOP KOL) -Developing KOL management plan with MSL team in collaboration with R&D/Business Unit -Maintains strong scientific collaborations with thought leaders within TAs to efficiently collect medical needs. Developing the DA (Disease Area) strategy aligned with the brand strategy under supervision of TA (therapeutic area) 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 (Integrated Evidence Generation Plan) -Driving and executing MAF study in collaboration with KOLs and MAO (Medical Affairs Operation) -Generating publications of MAF study collaborating with KOLs and MAO Managing MAF-initiated clinical/non-clinical study -Evaluating new IIS(Investigator Initiated Study) proposals 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 (Health Care Professionals) -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 inqueries and providing appropriate information to product strategy Evaluating, developing and implementing training programs designed for further improvement of strategic capability by assessing needs, skills and scientific knowledge Managing operational TA budget and allocating human resources based on brand strategy and product life cycle Developing and Managing TA strategy aligned with other critical functions/regions (R&D/Business Unit/Asia Pacific Region/Global) -Supervision of Medical Affairs Plan (MAP) -Provides input into early development through core membership of x-functional project team. -Assigning members for product development teams (JCoT/Japan Compound Team, IEGP/Integrated Evidence Generation Plan etc ) -Provides input into brand strategy 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 (Janssen Japan) •R&D, Pharmacovigilance, PMS and Regulatory Affairs leaders in JPKK •All Medical Affairs leaders and members Qualifications 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 LIST JOB SPECIFIC EXPERTIES/EXPERIENCE Candidate needs to meet at least one of the below requirements. (and/or) -At least 5 years working experience related with PH TA and have deep knowledge. -5 years or more working experience in Medical Affairs organization as TA specialist or MSL. -5 years or more working experience in pharma company in Marketing, R&D or other strategic functions related with PH or cardiovascular therapeutic area. RELATED EXPERIENCE 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. EDUATION/CERTIFICATION: Required: BS/BA Preferred: MS, MBA, PhD, Medical doctor license *Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances). Primary Location Japan-Tokyo-To-Chiyoda- Organization Janssen Pharmaceutical K.K. (7195) Job Function R&D Requisition ID 2206019541W