Objectives:

• Reporting to Medical Director

• To provide medical and scientific support to healthcare professionals through scientific communications and support for clinical research to facilitate a medical and scientific bridge between company and the healthcare community.

• To provide specialist medical and scientific advice to colleagues to drive the appropriate use and commercial success of company products/ medicines.

Responsibilities:

• Medical Affairs function

• Provides medical and scientific inputs for the development of launch plans, plans of actions and activities of responsible products

• Provides scientific advices in the organization of major symposia and medical advisory board meetings

• Provides medical supports for any medical issues related to responsible products

• Provides medical comments/advices to concerned colleagues in developing relevant promotional materials and product advertising activities according to relevance SOPs

• Provides medical inputs, including relevant document for the development of hospital formulary listing packages

• Provides appropriate training on medical part of responsible products and related diseases

• Continually updates sales staff on medical/scientific aspects of responsible products

• Provides scientific comments for submitted Investigator Initiated Research (IIR) from HCPs as per relevant SOPs and other processes

• Responsible for preparing study protocol, study budget, executing study and completing the study report as a study leader for local clinical study

• Provides medical input on program/protocol feasibility surveys

• Provides medical input in completing Adverse Event report

• Provides medical input to local Outcome Research staff on products and disease within responsible therapeutic areas

• Scientific discussion with investigator-author in preparing IIR study publication

• Reviews translated Local Package Documents/Patient Information Leaflets to ensure accuracy and optimal medical standard of practice

• Reviews submission packages for unconditional approval by Thai FDA

• Functional Administration

• Develops and initiates working system pertaining to responsible medical affairs activities in order to improve and enhance work efficiency

• Handle correspondences – related with responsible medical affairs activities with overseas and local both internal and external parties

• Ensures the maintenance of relevant medical affairs related information/documents/correspondence etc. in confidentiality, accuracy and easy retrieval system

• Submits Medical Affairs monthly operating report to Medical Director

• Standard Operating Procedures (SOPs) and Company Compliance Regulation

• Ensures and monitors the scientific parts of company educational activities such as Symposium, Local education program, speaker development program to be complied with relevant SOPs and company regulation

• Ensures the medical and scientific parts of promotional materials and product advertising activities of responsible products to be compliance with relevant SOPs and company regulation

• Medical Support, Advice and external partnership

• Provides guidance on company’s position against adverse drug publicity and issues

• Assists regulatory affairs in answering queries from local FDA staff and medical experts on registration recommendations to overseas and local both internal and external colleagues as needed

• Keep abreast of local medical regulation changes and ensures the company policy is aligned with those changes if relevant

• Maintains awareness of competitor intelligence and provides information to relevant colleagues

• Develops and enhances partnership with relevant Medical Associations and Royal Thai Medical College

• Liaises with KOLs to build rapports when applicable