[Janssen] Medical Compliance Lead

POSITION SUMMARY To continue the drive for quality of all medical business by increasing compliance with relevant Global and Local quality standard through continuous local procedure development, training and quality check in Japan. To strengthen enforcement on Medical Compliance, by leading and facilitating the endorsement, training and monitoring process of Medical Compliance procedure. PRINCIPAL RESPONSIBILITIES may include but not limited to Medical Affairs Compliance(70%) Lead medical team to implement all the projects and events aligned with the SOPs, WI, and company policy in Medical Affairs division. Coordinate audit and inspection with HCC and Business quality team, medical affair colleagues, and other stakeholders to conduct audit readiness, audit interview, and CAPA/MAP if needed. Responsible for training management timely for MAF core training curriculum, company level training based on company policy. Organize trainings on appropriate medical related SOP/WI to medical colleagues. Develop, maintain and optimize the local process for Medical Affairs Division, consistent with Global SOP requirements or company policy. Responsible for arranging trainings to Medical staffs on the relevant policy, procedure and SOPs. Medical Affairs Quality(15%) Play a leading role in building quality culture and performing quality tasks initiated by Japan MAF. Actively communicate and share quality related information with functional team Work with functional head and key quality Subject Matter Experts (SMEs), i.e. Training Coordinator, Record Coordinator, etc. to ensure inspection readiness of function. Conduct the local impact assessment of global procedural documents and if applicable, support development and management of associated local procedural documents. Facilitate inspections/office audits and support timely CAPA setting and implementation. Perform risk assessment of function, work out remediation plan and monitor progress and effectiveness through periodic review. Support to perform impact assessment of new/revised local regulations, guidance and standards if needed. Oversight and monitor functional compliance metrics, audit findings and issues (including appropriate escalation). Compliance management on cross-functional collaboration platform and system(15%) As a SME, collaborate with cross-functional teams (R&D QM team, BQ and HCC/legal/Privacy Policy/IT) to ensure medical activities and trials are implemented in high quality aligned with compliance and audit response timely Collaborate with AP and Global medical team to learn the best practice from them. Collaborate with HCC, legal, finance, procurement and other stakeholders to ensure well understand and familiar with the most updated regulatory, SOPs and guidelines and project timeline on track Qualifications Education Bachelor degree or above, medical compliance is preferred At least 5 years’ working experience in pharmaceutical company. Rich experience on medical affair, SOP and quality management (audit and CAPA) are preferred. A good understanding of the varying medical and marketing practices and perspectives across Japan, regional and overseas experience is a plus. LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED: Proven skills at developing and managing varied relationships within and outside the company. High customer and external industry insight High responsibility and ownership. Very strong and demonstrable presentation, communication and influencing skills that can impact at all levels. Excellent organizational skills, good communication skill. Good project management, time-management skills Strong leadership, motivated to develop, guide and reward high performance teams Good oral and written skills in both Japanese and English. Adherence to Johnson & Johnson Credo and have the right compliance mind-set EXTERNAL AND INTERNAL INTERACTIONS The role involves extensive interactions with: Health Care Compliance Sales and Marketing team in local Operating Company Legal, Privacy Policy, IT and other stakeholders in local Operating Company Business Quality in local Operating Company Medical Affairs Operation (MAO) All Medical Team leaders and members Global and AP medical team ======================= 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 2206042093W