职位描述
JOB SUMMARY
The individual will serve as a (key) scientific contributor for the development and execution of preclinical strategy. The individual will contribute to/independently complete the design, execution, analysis and interpretation of preclinical studies to understand the safety and efficacy of products.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable China and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Liaison with Business Partners
Provides preclinical scientific input on and assist to develop preclinical strategy as needed.
Communicates progress and milestone status to key stakeholders.
Preclinical Sponsor Oversight
Provides input and reviews for study protocols and reports from external preclinical studies.
Oversight of the study implemented in external labs to ensure compliance, scientific soundness, and integrity of the study.
Preclinical Study Execution
Planning and executing preclinical animal studies as needed.
Responsible for design of preclinical animal studies as needed.
Performs the role as designated Study Director as needed.
Responsible for ensuring compliance with all country, local and Company regulations, policies, and procedure.
Performs other duties assigned as needed
Requirements:
Doctorate degree preferred in veterinary medicine, medical, biological sciences, biomedical engineering, and related major. Master’s degree required. At minimum 3 years of experience in preclinical research experience in a medical device or pharmaceutical setting. GLP background is preferred.
Experience with large animal preclinical studies as study director is preferred.
General knowledge of Preclinical Research is required. Knowledge of NMPA regulations related to preclinical research is highly desired.
General knowledge of animal and human anatomy and physiology, surgical principles & theory, as well as biological systems is highly desired.
Skills to develop tactics to successfully complete programs/projects/studies is required including trouble shooting skills.
Able to articulate scientific basis for decisions to project team partners.
Good communication skills to facilitate smoothly work cross functionally.
Good English communication (both written and verbal) skill is required.
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