Medical Affairs Manager
Medical Affairs Manager
Posted on :
23-08-2025
Employer Active
1 Vacancy
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Job Description
Duties and Responsibilities (General summary essential functions and authorities etc.)
General Summary
The purpose of the position is to strategically provide medical supervision and support to business activities and internal/external customers.
Responsibility()
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 surveye.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 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.
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 patternsincluding the scientific activities taking place within the disease areaand 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 companys 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.
Requirement including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
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Personal Requirements ( include experience knowledgeskills 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.
General Summary
The purpose of the position is to strategically provide medical supervision and support to business activities and internal/external customers.
Responsibility()
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 surveye.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 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.
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 patternsincluding the scientific activities taking place within the disease areaand 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 companys 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.
Requirement including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
///
Personal Requirements ( include experience knowledgeskills 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.
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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