Cardinal Health Nakhon Pathom Mueang Nakhon Pathom District Thailand
2 months ago
ROLE SUMMARY 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. ROLE RESPONSIBILITIES Provide Medical Supports, to the business unit from scientific point of view Review regulatory, medical and safety materials from scientific point of view to ensure full... compliance with local medical, regulatory and legal requirements. In compliance with ethical business principles provides scientific support and expertise to cross-functional team and other internal stakeholders with respect to materials creation and approval, advertising and educational programmes, clinical research, medical information, regulatory issues. Manage issues that may adversely affect business. Challenge competitors' claims and defending Pfizer products and promotional materials when challenged Support Country Medical Director in shaping and executing the local annual COVID-19 Protease Inhibitor (Paxlovid) Medical Budget, owning responsibility for appropriate spending in full alignment with local annual Paxlovid Medical Plan. Provide educational support inside cross-functional team as well as Field Force training in appropriate therapy area medical knowledge. When applicable, participates in processes of local COVID-19 medical colleagues development and supervision Interact with medical affairs, internal colleagues, and external healthcare communities in a professional, scientific-based manner In compliance and close coordination with the Regional Medical Lead develop key projects to drive products through proper dissemination of medical and scientific information in the country. Coordination of administrative procedures in accordance with Pfizer polices. Maintenance of all relevant and required MAPP documents, procedures and conditions External stakeholders relations, safety reporting and medical information Target and develop ongoing relationships with relevant bodies, institutes and opinion leaders for COVID-19 to ensure that they always have the accurate, updated and comprehensive medical information aligned with Pfizer strategies and to foster Pfizer's efforts to establish and maintain its therapeutic leadership position, including but not limited to: Development working relations with key establishments (i.e. patient organizations, professional organizations, medical societies) Development and maintenance support and relationships with Key Opinion Leaders Participation in advisory/advocacy boards and develops the advocacy of the company brand and product brands Participation in activities related to building public relations between Pfizer and external stakeholders Provides responses to medical inquiries coming from field force for specified therapeutic area, being responsible for tracking and maintenance of needed information related to medical inquiries Provide Medical Support, research-wise Contribute to development of Regional and Global Clinical Development plans with CTSC, iSDL and RMMs ensuring local clinical needs are addressed. Support CTSC, iSDL, RMMs in clinical trial associated issues in Taiwan (protocol/site feasibility questionnaires, recommend and assess clinical trials centers assessments) Provide scientific comments for submitted Investigator Initiated Research (IIR) from health care professionals, as per relevant Pfizer SOP and local processes. Development of support for Investigator Initiated Research grants (IIRs) and management of associated relationships, including contacts in the appropriate therapy area, assistance in publication preparation of results of IIR. To be consistent with Safety Reporting Plan, perform and document regular review of individual subject safety data and perform review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide – for Clinicians and SAF09 SOP QUALIFICATIONS Education & Experience Medical, or postgraduate level science. Fluent English spoken and written Therapeutic area experience in Infectious Disease and/or Vaccines Professional experience in hospitals, research or pharmaceutical industry desirable. Managerial An understanding of the compliance framework for medical interactions in relation to local regulation i.e SI 54, IPHA code of practice. High degree of cross-functional collaboration, teamwork. Ability to clearly communicate information and concepts which may be complex in Good understanding of the local healthcare environment at national and regional level. Good knowledge of pharmacovigilance and regulatory legislation and how it impacts the product portfolio. Able to review, evaluate, interpret, and present complex scientific data. Excellent verbal and written communication skills including scientific writing skills and strong interpersonal skills 2 years-experience in Pharmaceutical Industry Project and process management: ability to manage projects and cross-functional Administrative excellence: attention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc. Organizational skills: Works independently. Receives instruction #LI-PFE Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical #LI-PFE Karrieren bei Pfizer sind einzigartig. In unserer Kultur der individuellen Verantwortung glauben wir an unsere Fähigkeit, die Zukunft der Gesundheitsversorgung zu verbessern und an unser Potenzial, viele Millionen Leben zum Besseren zu wandeln. Wir suchen stets nach neuen Talenten für unsere globale Gemeinschaft, um gemeinsam neue innovative Therapien zu entwickeln, die die Welt zu einem gesünderen Ort machen
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