商丘招聘

I. Purpose of this job:
To enhance the medical competence of Clinical & Medical & Regulatory (CMR) Dept. and make biggest contribution to the business of company via clinical trial design and giving medical supports to clinical study, medical reporting, medical affairs & regulatory affairs in CMR Dept.

II. Area of responsibilities:
a)Main Tasks:
1. Responsible for phase 3 and phase 4 clinical trial/study design initiated by Novo Nordisk in align with regulatory requirement and/or marketing strategy
2. Prepare extended protocol synopsis for clinical trials and studies and prepare full protocols when necessary
3. Take medical responsibility to ensure appropriate trial execution and evaluation, e.g. medical support for investigator meeting, handling medical related issues during operation, etc.
4. Prepare relevant material to answer questions raised by HA officials and professionals from clinical point of view
5. Review labelling of new products.
6. Review and approve medical content of study reports and publications based on result of clinical studies.
7. Protocol review for investigator initiated studies
8. Provide medical expertise in a therapeutic area with focus on a specific project and be the internal spokesperson for medical aspects of a given project.
9. Responsible for preparation of high-level medical activities, e.g. external result meeting, Advisory Board meeting
10. Provide training of updated knowledge of products and diabetes to improve the internal medical capability.
11. Provide instruction and technical coaching for others for specific clinical programme

b)Supervision:
None

c)Main customers:
Internal: colleagues from CMR Dept., MKT
External: doctors and investigators, health care professionals and officials.

III. Education and Experience Requirements of the Position:
1. Master degree or above of clinical medicine
2. At least 3 years working experience as practicing physician, preferably in diabetes or with working experience in global pharmaceutical companies
3. Working experience of clinical trial is preferred
4. Have good understanding of requirements for protocol preparation
5. Have good understanding of requirements from SFDA on registration trial
6. Be good at interpersonal communication
7. Proficiency in oral and written English
8. Good computer using skills

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