Johnson & Johnson Careers
Medical Affairs Manager
Requisition ID: 1905758862W
1. Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
The purpose of the position is to strategically provide medical supervision and support to business activities and internal/external customers.
Evidence Generation (20%): To provide medical strategic plans and solutions to support product registration, and 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.
Company Initiated Study (20%): 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.
Investigator Initiated Study (20%): 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.
Clinical Evaluation Report (10%): To partner with other functional stakeholders, to prepare Clinical Evaluation Report to support product registration.
KOL Management (10%): 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.
MIR (10%): 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 (5%): 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.
Medical Governance (<5%):
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.
2. 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.
– At least 2 years’ experience practicing medicine, in surgical department and cardiovascular department. Or related working experience in industry (R&D, MA, MSL, medical MKT) in above mentioned specialty.
– Good communicate skills in English, both orally and in writing.
– Having good co-operation abilities and a positive character.
Johnson & Johnson Medical Shanghai Ltd. (7055)