HireDiversity

Shanghai, CN

Assistant Medcial Affairs Manager-Shanghai-000009TK

Description

1. Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)

??????(????,????,???)

General Summary(????)
The purpose of the position is to provide high-quality scientific data as well as medical governance in accordance with health compliance to enhance business development, to ensure medical device safety vigilance according to company policies and local regulations and to provide value-added medical support to healthcare professionals and assist in building and maintaining customer relationships through professional interactions.

Responsibility(????)

? To be the expertise in the knowledge of products,patient treatment trends,clinical trials and scientific activities within the disease area and must continuously update this expertise and knowledge.

? Ensure promotional materials are in label, accurate, fair, objective and in compliance with local regulations, scientific and ethical standards, HCC policies and ICH GCP.

? Ensure the qualification of Health Care Professional by evaluating the authenticity and accuracy of KOL's Curriculum vitae.

? 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.

? Provide evidence-based medical information, clinical evaluation, publication support, professional trainings and presentations or any other value-added programs in a certain area per requests from internal or external customers.

? Prepare medical letter to address unsolicited requests from healthcare professionals for information on the efficacy and safety of all marketed products in China.

? 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 and submit the reportable Adverse Events to the competent Health Authorities in compliance with the company's procedures and the local regulations.

? Collect medical device safety vigilance information regarding either JJMC/JJMS/HCS products or competitor's products, from public resource regularly, evaluate and share it with Franchise marketing team.

? Assist in collection of investigators' proposals for local and regional clinical activities, ensure these proposals are reviewed within the local clinical trial review committee, manage Asia Pacific and Global Franchise approval processes, and provide timely feedback to investigators.

? Assist in protocol and CRF design in a JJMC/JJMS/HCS-sponsored clinical trial.

? Develop an understanding and competence of SOPs,ICH/GCP,as well as ethical standards.

? Build up and maintain healthy relationships with internal customers and external experts.

? Take on any other task as assigned by line-manager/medical affairs manager.

? Other responsibilities defined in written procedures.( ??????????)

Principle Relations (inside &outside company)??????(???????)
- MA&CR team in JJMC, regional, global and source companies
- RA and QA team in JJMC, regional, global and source companies
- JJMC HCC, Legal, Finance team,
- JJMC Franchise Marketing/Sales/Training and ProfEd team,
- Key opinion leaders and investigators

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 clinical medicine,pharmacology or life science
- At least 3 years experience in practicing medicine or medical product develop
- Industry experience in pharmaceutical/medical device marketing,clinical operation,or medical affairs would be preferred.
- Be able to communicate in English,both orally and in writing.
- Good presentation skill
- Having good co-operation abilities and a positive character.

Required Competencies ??????(Level 1-4, see Appendix A)
- Clinical trial expertise 1
- Statistics & data analysis 2
- Disease area knowledge 2
- Product/Procedure/Therapeutic area knowledge 2
- Scientific presentation & publication 2
- Customer & market insight 2
- Managing customer & internal partners 2
- Cultural diversity 2
- Project Management 1

Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Clinical Research MD