Medical Affairs Manager (Doctor of Medicine degree only)

Job Description

• The Medical Affairs Manager (MAM) is responsible for supporting scientific and clinical knowledge of all medical affairs activities and its related in Thailand/Indochina as assigned. MAM lead medical affairs strategy and execute value-creating medical activities and also provides scientific/clinical supports for all assigned activities pertaining to medical marketing and other related activities.

MAM ensures all activities under responsibility complies with relevant regulation and company SOPs. MAM provides professional advice including updated medical information such as national guideline for treating specific disease, as well as medical rules and regulation. The MAM also represents the company position on medical affairs-related matter in dealing with health authorities concerned.

1. Medical Affairs Function
   • Provides medical and scientific inputs for the development of launch plans, plans of action (POAs), and activities of responsible products
   • Provides scientific advices in the organization of major symposia and medical advisory board meetings
   • Provide medical supports for any medical issues related to responsible products
   • Provides medical comments/advices to concerned BU colleagues in developing relevant promotional materials and product advertising activities according to relevant SOPs and coordinate with Center of Excellence for material review
   • Provides medical inputs for the development of hospital formulary listing packages
   • Provide appropriate training on medical part of responsible products and related diseases
   • Continually updates commercial team on medical/scientific aspects of responsible products
   • Ensures consistent, balanced, and accurate responses to internal/external medical information queries.
   • Provide scientific comments for submitted Investigator Sponsored Research (ISR) from health care professionals, as per relevant company SOP and local 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 Manager on products and diseases within responsible therapeutic areas
   • Scientific discussion with investigator-author in preparing ISR study publication.
   • Reviews translated Local Package Documents (LPDs)/Patient Information Leaflets (PILs) to ensure accuracy and optimal medical standard of practice.
   • Reviews submission packages for unconditional approval by Thai FDA

2. 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/document/correspondence in confidentiality, accuracy and easy retrieval system.

3. Standard Operating Procedures (SOPs) and Company Compliance Regulation

• Ensures and monitors the scientific parts of company educational activities such as company symposium/local educational program/speaker training program to be compliance 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

4. Medical Support/Advice and External Partnership

• Develops and enhances partnership with relevant Medical Associations and Royal Thai Medical College
• Liaises with key opinion-leaders to build rapport, when applicable
• Provides guidance on company's position against adverse drug publicity and issues
• Assists Regulatory Affairs team in answering queries form local FDA staff and medical experts on registration dossier/labeling/safety/efficacy of responsible products.
• Provides medical information, comments, advices, and recommendations to overseas and local both internal and external colleagues.
• 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 BU colleagues

Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.