天津招聘

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.

HR: 95601

Functional Area: Regulatory & Medical Affairs

默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。

默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。