J&J Family of Companies Manager 2, Medical Affairs MD in Shanghai, China
Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
General Summary （基本概况） The purpose of the position is to provide preclinical support to business activities and internal/external customers in terms of preclinical study/testing and evidence.
Responsibility ( 工作职责 )
To provide strategic preclinical support to the business and collaborate with external customers/users/investigators in leading and/or implementing preclinical activities relating to animal study and bench-top testing. Activities include but not limited to preclinical strategy development, evidence gap analysis, study protocol preparation, new animal model and technology/methodology development, study/testing execution, quality control, on-site technical support, data collection and analysis, report writing and publication.
To collect investigators’ proposals (i.e., IIS) for local and regional preclinical activities, to ensure that these proposals are discussed within the local review committee, to coordinate Global Franchise approval processes, and to provide timely feedback to investigators. Coordinate and track the progress on contracting, project conduction and reporting after approval.
To provide preclinical input to the Regulatory and/or R&D teams on animal study and bench-top testing as Subject Matter Expert (SME), in terms of preclinical study/testing protocol design, result interpretation, veterinary medicine, GLP, animal welfare, etc. in NPI and NPD processes. Maintain scientific contacts with global Preclinical counterparts, external experts and local regulators.
To develop and maintain professional relationship with external experts, in accordance with the company strategy to further understand and gain both insight and/or input into treatment pattern and device use/development, including the scientific activities taking place within the disease area, and the preclinical study/evidence needs.
To partnership with internal stakeholders (e.g., Marketing, Regulatory Affairs, global Preclinical) to deeply understand unmet needs and hurdles from business and regulatory sides, and develop preclinical strategies, solutions and plans to support product adoption, market access, and regulatory approval.
To develop SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation, if applicable.
Other responsibilities defined in written procedures. （流程中规定的其它职责）
Principle Relations (inside & outside company) 主要工作关系 ( 公司内部和外部 )
Business team, incl. Marketing, Sales, ProfEd and Training
Preclinical Research organizations, global
Medical Affairs team in China, regional, global and source companies
Regulatory Affairs team in China, regional, global and source companies
R&D team in China, regional, global and source companies
Finance business partners
Health Care Compliance and Legal teams
Key Opinion Leaders and surgeons
China health authorities, incl. China and provincial food and drug administrations
Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和 / 或知识和 / 或培训和 / 或相关工作经验）
Personal Requirements ( include experience, knowledge ， skills and education)
At least master’s degree of veterinary medicine, animal science or relevant background
At least 5 years’ industry practicing experience in pharmaceutical/medical device marketing, preclinical operation, veterinary R&D or animal laboratory/service
A National Veterinarian License is preferred
Good communication skills in English, both orally and in writing
Having good co-operation abilities and a positive character
Required Competencies 胜任能力要求 (Level 1-4, see Appendix A)
Managing Complexity and Change 3
Stakeholder Engagement 3
Project Management 3
Communication and Presentation 2
Business Acumen 3
Scientific and Technical Leadership 2
External Focus 2
Preclinical Study Execution Expertise 3
Preclinical Study and Model Design 3
Statistical Knowledge and Analysis 2
Product/Medical Procedure Development 2
Medical Writing 2
Johnson & Johnson Medical Shanghai Ltd. (7055)
J&J Family of Companies
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