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- 职位介绍
- Your role: 1. Related to marketing or other business activities • Develop medical plan with medical & BU independently. • Initiate strategic studies of marketed products to come out medical opinion. • Responsible for publication. • Initiate strategic portfolio evaluation and provide medical support for business growth. • Work as internal advisor to MA and marketing. 2. Related to Clinical Development • Primary contact person for all medical/safety aspects within a given study. • Protocol/amendment (related to medical sciences) development and finalization. • Planning, development and execution of Phase 3 and 3B through Phase 4 clinical research, RWE trials, ensuring the clinical program includes a robust holistic evidence package. • Medical training for entire study team, investigators and CRO staff (if applicable). • Medical and disease state education, publications, medical information, and medical affairs advisory boards. 3. Related to Regulatory Affairs • Involved in the preparation for the medical sections of regulatory submissions. • Prepares the medical section of briefing documents for CDE evaluation meeting, pre-meeting with regulatory authorities. • Develops scientific reports or responses to study-specific medical issues that may be raised by regulatory agencies. Who you are: 1. Master or advanced degree in clinical medicine. 2. At least 2 years multi-national pharmaceutical companies experience in medical. 3. Good English at listening, speaking, writing and reading. Able to communicate with global by TC. 4. Good communication skills (written and oral) of both scientific and non-scientific information. 5. Strong medical knowledge in the therapeutic area. 6. Professional knowledge on clinical medicine, metabolism is preferred. 7. Knowledge of policies and procedures in Clinical Trials and drug Registration. 8. Ability to face challenges. 9. Self-learning ability. Functional Area: Regulatory & Medical Affairs
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