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.
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 companyExcellent ability to prioritize and handle multiple tasksGood project management, analytical, decision-makingGeneral knowledge on drug development and clinical research an advantageKeen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in generalExcellent communication skills including strong presentation skillsHigh customer orientationExcellent skills to set stakeholders relationship, networking, tact and diplomacyFluent in English and Thai (both verbal and written)Good computer skills and ability to learn and to adapt working with IT systemsKnowledge of ICH, GCP, regulations, industry practices and applicable standardsStrong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrityWillingness to travel upcountry and overseaCORE 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 areasProvide medical/scientific input into marketing strategy and key commercial initiatives, as required. Deliver scientific and medical education programs to healthcare professionalsReview 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 balancedDevelop scientific material and initiates its request for approvalCo-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 projectAssures that clinical research program design meets scientific objectives and is aligned with our Medical Affairs StrategyEnsure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studiesBuilding relationships with Investigators and applying their inputs to enhance study design and protocolsProvide monitoring visits and site management for a variety of protocols, sites and therapeutic areasCollaborate and liaise with study team members for project execution support as appropriateServes as scientific expertise on clinical research matters and govern regulatory requirementsAdminister and maintain appropriate documentation such as protocol approval and related study expenditure to internal stakeholdersAccountable for supporting sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictabilityManage 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 metricManage CLIMATE and Clinical Tracker SharepointResponsible 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 goalsFUNCTIONAL COMPETENCIES:
Project Management
Able to plan organize, assess and monitor the projects with team, stakeholders and sponsors to ensure delivery on timelines. Monitors and controls project performance
Stakeholder Management
Initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization (e.g., customers, peers, cross-functional partners, external vendors, regulatory bodies, alliance partners) who are willing and able to provide the information, ideas, expertise, and/or influence needed to advance understanding of business issues and achieve business goals. Proactively foster appropriate relationships with key external stakeholders and senior level agency officials
Analytical and Insights Driven
Collects, integrates and analyses all relevant data and information and draws logical and objective conclusions from the data and validates them to enable sound decisions
Direction
Provides direction to commercial team and projects to develop successful Medico-Marketing strategies and to meet business objectives
Scientific prominence
Provides strategic direction based on most up to date scientific knowledge / medical practice. Act as a scientific / medical liaison to cross functional teams