天津招聘

KEY TASKS & RESPONSIBILITIES
1. Related to marketing or other business activities
1) Collaborate with marketing for the organization of KOL meetings and advisory boards meetings
2) Initiate, conduct IST and PMS of marketed products to come out medical opinion in order to support marketing needs
3) Responsible for publication:
？ Develop the domestic and global (when requested) publication strategy
？ Authors/reviews abstracts and publications of domestic IST or PMS , and global (when requested) studies
4) Represents Merck Sereno Medical to KOL and medical organizations
5) Provide medical training for sales and marketing , review and update the relative training materials yearly based on needs
6) Evaluation scientific aspects of in- and out-licensing products
7) Provides medical support for Internal Marketing Teams in the relevant therapeutic area (like: promotion material development and check etc.)

2. Related to Clinical Development
1) Primary contact person for all medical/safety aspects within a given study
2) Any medical aspects having global implications (e.g. safety updates, important medical decisions regarding the study indication) will be discussed between MA and Global Project Leader
3) Protocol/amendment (related to medical sciences) development and finalization
4) Medical check for site selection
5) Medical discussions with investigators
6) Medical training for entire study team, investigators and CRO staff (if applicable)
7) Answer all medical related questions during the study, e.g. questions from EC-committees, investigators, etc.
8) Ongoing data review in clinical trials for patients’ safety, efficacy, validity
9) Gives safety updates to Global Project Leader
10) Reviews or writes medical narratives and ensures that the narratives meet an acceptable medical standard in the Medical Research Report
11) Supports the coding team for medical history, concomitant medications and adverse event coding
12) Reviews the statistical tables and interprets clinical data for the Medical Research Report
13) Develop, reviews and approve the final study Medical Research Report both in English and Chinese

3. Related to Regulatory Affairs
1) Involved in the preparation for the medical sections of regulatory submissions (IND and NDA)
2) Prepares the medical section of briefing documents for CDE evaluation meeting, pre-meeting with regulatory authorities
3) Develops scientific reports or responses to study-specific medical issues that may be raised by regulatory agencies

4. Related to the project management
Responsible to track the project the status and complete the monthly report

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。