Sr MA manager, Scientist

Beijing - China

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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 companys 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 activitiesto 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 patternsincluding the scientific activities taking place within the disease areaand 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 surveye.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 knowledgeskills 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

Required Experience:

Manager

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 companys 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 activitiesto 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 patternsincluding the scientific activities taking place within the disease areaand 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 surveye.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.

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:

Required Experience:

Manager

Key Skills

Laboratory Experience
Immunoassays
Machine Learning
Biochemistry
Assays
Research Experience
Spectroscopy
Research & Development
cGMP
Cell Culture
Molecular Biology
Data Analysis Skills

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About Company

Johnson & Johnson

About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

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