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
Qualifications:
Degree in Doctor of Medicine (M.D.) at minimum or equivalent or higher than post grad degree in Pharmacy
Experience of clinical practices experience and knowledgeable in clinical study process and protocols, and outcome research is preferable
Minimum 2 years of equivalent experience in Medical affairs from Pharmaceutical Industry is strongly preferred
Well-reserved in medical ethics and regulations
Proven business acumen to balance with scientific points of view
Strong analytical skills with experience in project management and training
Good interpersonal and presentation skills
Fluent command of English
Computer literacy (MS Word, MS Excel, MS PowerPoint as standard requirements)
Excellent negotiation and presentation skills
Good planning/organizational skills
Very strong Project Management
Thai nationality
If you would like to apply for this position, please send your resume to wmarlow@utcthailand.com or fill in your information on the section below.
*All applications will be treated in strict confidentiality. All material submitted in connection with your application will become part of our confidential recruitment files. We regret that only shortlisted candidates will be notified.