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Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Beijing, China

Job Description:

Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.) 主要工作职责（基本概况，主要功能，权限等）
General Summary（基本概况）

The purpose of the position is to strategically provide medical supervision and support to business activities and internal/external customers.
 

Responsibility(工作职责)

• Medical Governance: To ensure Health Care Compliance on promotional material and Health Care Professional qualification in accordance with J&J policy, company GOP/SOP and related working procedure.
• To ensure the contents and medical claim in following parts of IFU, including Indication, contraindication, potential complications, clinical trial related contents, caution & precaution and adverse event, are accurate, fair and objective.
• MIR: To provide scientific and medical information to internal and external customers, including unsolicited requests from healthcare professionals, to ensure clinically appropriate and safe use of company products.
• Safety Vigilance: To work with other stakeholders as a team to ensure that all the information regarding Adverse Events in the field is collected to facilitate a correct and transparent communication of Adverse Events internally, and properly review the Adverse Events. Evaluate and submit the reportable Adverse Events to the competent Health Authorities in compliance with the company’s procedures and the local regulations. Keep good documentation on Adverse Event reported to the competent Health Authorities.
• To provide medical strategic plans and solutions to support business team on product and/or procedure management for related therapeutic area, in terms of evidence generation plan and proposal, evidence publication and dissemination, and other related activities.
• To collect investigators’ proposals (IIS) for local and regional clinical activities，to ensure that these proposals are discussed within the local clinical trial review committee, to coordinate Global Franchise approval processes, and to provide timely feedback to investigators. Coordinate and track the progress on contracting, project conduction and reporting after IIS approval.
• To develop and maintain professional relationship with external experts, in accordance with the company strategy to further understand and gain both insight and/or input into treatment patterns，including the scientific activities taking place within the disease area，and the needs and behaviors of healthcare professionals.
• To provide strategic medical support to the clinical research operation team on medical activities relating to the conduct of a trial or survey，e.g. protocol preparation, safety review, study report writing and publication. Maintain scientific contacts with local investigators.
• To partner with other functional stakeholders, to prepare Clinical Evaluation Report to support product registration.
• To develop an understanding SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation, if applicable.

Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required 基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
Personal Requirements ( include experience, knowledge，skills and education)
个人背景要求 （包括经验，知识，技能和教育背景）

• At least master degree of medicine, bioengineering or life science
• At least 4 years’ experience practicing medicine or products develop experience
• Industry experience in pharmaceutical marketing, clinical operation, or medical affairs would be preferred
• Good communicate skills in English, both orally and in writing
• Having good co-operation abilities and a positive character

Required Competencies 胜任能力要求

• Refer to SMA Competency Model

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization of Tasks, Product Strategies, Scientific Research, Strategic Thinking, Team Management