Johnson & Johnson Careers
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Medical Compliance Manager
Requisition ID: 1805642096W
Lead medical team to implement all the projects and events aligned with the SOPs, WI, and company policy in Medical Affairs department. 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 China Medical Affairs Department, consistent with Global SOP requirements or company policy. Responsible for arranging trainings to Medical staffs on the relevant policy, procedure and SOPs.
Copy Review Committee (CRC) Management
Manage all Copy Review Committee (CRC) SOP and workflow to ensure medical compliance in all educational and promotional events
· Make sure all in-scope materials are properly reviewed and approved
·Improve CRC material quality from development phase
·Improve CRC review efficiency and accuracy
· As a SME, collaborate with cross-functional teams (R&D QM team, BQ and HCC/legal) to ensure medical activities and trials are implemented in high quality aligned with compliance and audit response timely
· With GCO team to get the clinical trials update timely
· With AP and Global medical team to learn the best practice from them.
· 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
ESSENTIAL KNOWLEDGE & SKILLS:
· 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 organisational 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 Chinese and English.
· Adherence to Johnson & Johnson Credo and have the right compliance mind-setEXPERIENCE:
· Master 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).
· A good understanding of the varying medical and marketing practices and perspectives across China, regional and overseas experience is a plus.
Xian-Janssen Pharmaceutical Ltd. (7043)