PRIMARY OBJECTIVE:

The position represents the affiliate’s medical/ scientific voice of expertise for assigned relevant therapeutic areas and special task assignment. The position provides medical / scientific expert advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with key opinion leaders. It provides medical / scientific input into marketing strategy and key commercial initiatives, as required, and medical / scientific support for medical department activities under the direction of the Head of the affiliate medical function.

CORE JOB RESPONSIBILITIES:

• Develop and maintain in depth knowledge for assigned product(s)/ relevant therapeutic area(s)
• Provide expert medical/scientific advice for assigned products and related therapeutic areas
• Provide medical/scientific input into marketing strategy and key commercial initiatives, as required. Deliver scientific and medical education programs to healthcare professionals
• Review and approve promotional materials. Ensure that it is based on good clinical practice, is of the highest standards of medical accuracy and is fair, objective and balanced
• Develop scientific material and initiates its request for approval
• Co-operation on clinical research activities with the global and regional by taking responsibility for the implementation/ manage of local clinical trials, including IIS, BE, feasibility studies and non-interventional clinical research activities throughout project
• Assures that clinical research program design meets scientific objectives and is aligned with our Medical Affairs Strategy
• Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies
• Building relationships with Investigators and applying their inputs to enhance study design and protocols
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
• Collaborate and liaise with study team members for project execution support as appropriate
• Serves as scientific expertise on clinical research matters and govern regulatory requirements
• Administer and maintain appropriate documentation such as protocol approval and related study expenditure to internal stakeholders
• Accountable for supporting sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
• Manage internal TARC review and approval of local clinical activities in assigned therapeutic area(s)
• Lead local clinical trial application through central research committee (if required)
• Complete data entry to monthly metric
• Manage CLIMATE and Clinical Tracker Sharepoint
• Responsible and accountable for coaching and management of MA specialist performance including monitoring monthly metrics ensuring excellence in execution of his/her role towards achieving strategic and tactical Medical Affairs goals

EDUCATION/QUALIFICATIONS/EXPERIENCE:

• Bachelor’s degree in a pharmacy plus a higher education in a master’s degree.
• Minimum 2 years Medical Affairs Manager experience in pharmaceutical company
• Excellent ability to prioritize and handle multiple tasks
• Good project management, analytical, decision-making
• General knowledge on drug development and clinical research an advantage
• Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general
• Excellent communication skills including strong presentation skills
• High customer orientation
• Excellent skills to set stakeholders relationship, networking, tact and diplomacy
• Fluent in English and Thai (both verbal and written)
• Good computer skills and ability to learn and to adapt working with IT systems
• Knowledge of ICH, GCP, regulations, industry practices and applicable standards
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
• Willingness to travel upcountry and oversea