Medical Affairs Manager for Depuy- BeiJing-00000MKQ
Description
1. Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
General Summary
The purpose of the position is to strategically provide medical support for business development and ensure the health compliance from the aspect of medical governance of JJMC/JJMS/HCS.
Responsibility
To ensure Health Care Compliance on promotional material and Health Care Professional qualification in accordance with J&J policy, JJMC/JJMS/HCS GOP/SOP and related working procedure.
To work with appropriate JJMC/JJMS/HCS personnel to guarantee 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 collect investigators' proposals (IIS) for local and regional clinical activities，ensure that these proposals are discussed within the local clinical trial review committee，manage Asia Pacific and Global Franchise approval processes，and provide timely feedback to investigators. Coordinate and track the progress on contracting, project conduction and reporting after IIS approval from local, regional and global level.
To develop and maintain contacts with external experts，in accordance with the strategy developed by the company 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 health care providers.
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 provide strategic input on clinical evidence generation and dissemination to support franchise business development by utilizing EBM tool.
To develop an understanding SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation.
Other responsibilities defined in written procedures.
Principle Relations （inside ＆outside company）
- Clinical research team in JJMC/JJMS/HCS, regional, global and source companies;
- Medical affairs team in JJMC/JJMS/HCS, regional, global and source companies
- Regulatory affairs team in JJMC/JJMS/HCS, regional, global and source companies
- Quality assurance team in JJMC/JJMS/HCS, regional, global and source companies
- Clinical Quality Control/Assurance team in JJMC/JJMS, regional, global and source companies
- Franchise people, incl. marketing, sales, ProfEd and training;
- Finance business partners;
- Professional Education team;
- Health Care Compliance team
- Clinical research organizations, global, regional and local
- Key opinion leaders and investigators
- SFDA technical reviewers
Qualifications
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
Personal Requirements ( include experience, knowledge，skills and education)
- At least master degree of medicine，bioengineering or life science
- At least 4 years experience practicing medicine or product 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 (Level 1-4, see Appendix A)
- Clinical trial expertise 3
- Statistics & data analysis 2
- Disease area knowledge 4
- Product/Procedure/Therapeutic area knowledge 4
- Scientific presentation & publication 3
- Customer & market insight 3
- Managing customer & internal partners 3
- Cultural diversity 3
- Project Management 3
Primary Location:Asia Pacific-China-Beijing
Other Locations:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Medical Affairs
Description
1. Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
General Summary
The purpose of the position is to strategically provide medical support for business development and ensure the health compliance from the aspect of medical governance of JJMC/JJMS/HCS.
Responsibility
To ensure Health Care Compliance on promotional material and Health Care Professional qualification in accordance with J&J policy, JJMC/JJMS/HCS GOP/SOP and related working procedure.
To work with appropriate JJMC/JJMS/HCS personnel to guarantee 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 collect investigators' proposals (IIS) for local and regional clinical activities，ensure that these proposals are discussed within the local clinical trial review committee，manage Asia Pacific and Global Franchise approval processes，and provide timely feedback to investigators. Coordinate and track the progress on contracting, project conduction and reporting after IIS approval from local, regional and global level.
To develop and maintain contacts with external experts，in accordance with the strategy developed by the company 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 health care providers.
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 provide strategic input on clinical evidence generation and dissemination to support franchise business development by utilizing EBM tool.
To develop an understanding SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation.
Other responsibilities defined in written procedures.
Principle Relations （inside ＆outside company）
- Clinical research team in JJMC/JJMS/HCS, regional, global and source companies;
- Medical affairs team in JJMC/JJMS/HCS, regional, global and source companies
- Regulatory affairs team in JJMC/JJMS/HCS, regional, global and source companies
- Quality assurance team in JJMC/JJMS/HCS, regional, global and source companies
- Clinical Quality Control/Assurance team in JJMC/JJMS, regional, global and source companies
- Franchise people, incl. marketing, sales, ProfEd and training;
- Finance business partners;
- Professional Education team;
- Health Care Compliance team
- Clinical research organizations, global, regional and local
- Key opinion leaders and investigators
- SFDA technical reviewers
Qualifications
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
Personal Requirements ( include experience, knowledge，skills and education)
- At least master degree of medicine，bioengineering or life science
- At least 4 years experience practicing medicine or product 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 (Level 1-4, see Appendix A)
- Clinical trial expertise 3
- Statistics & data analysis 2
- Disease area knowledge 4
- Product/Procedure/Therapeutic area knowledge 4
- Scientific presentation & publication 3
- Customer & market insight 3
- Managing customer & internal partners 3
- Cultural diversity 3
- Project Management 3
Primary Location:Asia Pacific-China-Beijing
Other Locations:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Medical Affairs