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The PositionExternal Job Ad TextJob Summary:
Empower clinical research and external clinical collaboration to assure the success of product registrations.
Streamline local clinical evidence generation in a Total-Product-Life-Cycle manner to satisfy diverse business purposes.
Main Tasks & Responsibilities:
Within MRA, build up and optimize clinical capabilities in line with regulatory dynamic, including HGARC, DM, Statistics, clinical evaluation and Real World Evidence/initiatives etc., empowering clinical research and enhancing cooperation with different teams/functions.
Foster team culture of striving for excellence, promote talent pipeline to reflect the entire MRA strategy.
Explore or expand new opportunities with NMPA and academic associations in shaping clinical requirements, enriching approaches of evidence generation etc.
Strengthen the relationship and collaboration with GCP offices and HGARC through a long-term plan.
Stay strategic thinking in across-function collaborations leading a step-wised transition to the futuristic digital clinical trial era.
Explore a good and constructive working relationship with BAs and other departments to support the cross-functional projects
Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection
Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)
Basic Requirements of the Job:
Education& Qualifications:
Doctor degree in medical science, preferred to public health, medical laboratory or related majors
Understand pharmaceutical and/or medical device regulation and ICH/GCP
Language requirement: Mandarin (Native), English (Fluent)
Experience:
At least 15 years of working experience and 10 years of people leader experience in pharmaceutical or medical device industry with a focus on medical, clinical research, regulatory and related work. Preferred to versatile talents with varied experience beyond medical and Regulatory Affairs.
Proved team leadership and talent development skills. Excellent across-functional communication and collaboration.
Broader external connections and strong bonds with KOLs. Proved records in propelling business long-term growth.
Global view, steering execution excellence, and being presentable.
Travel Requirements:
Approximately 40% of time local and/or international travel.
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.