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
Qualifications
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
