Role Purpose : Serve as the Senior Physician in TA leading the Medical Role internally and representing the company externally in Area Medical Institutions and Healthcare Authorities. Lead the Medical Governance for the team and providing team Medical staff critical support in ensuring implementation, monitoring and enforcement of ethical standards. Ultimately Responsible for ensuring compliance with clinical trial standards within the team and, in partnership with the Business Unit Head, compliance with relevant Promotional & Marketing Codes. Leverage the team Medical Affairs role by ensuring commercially focused Medical input into strategic market development including Mergers & Acquisitions (M&A), and ongoing market support, whilst balancing the highest ethical standards in corporate medical governance. Provide consolidated product or disease input into International and Global Clinical Development strategies for Phase II through IV clinical plans to ensure central understanding of regulators / payors requirements in Key Area Markets; ensure efficient and effective study conduct locally. Drive Epidemiological & Health Outcome programs as well as responsible local studies (including Phase IV) to proactively ensure provision of reimbursable files and support both Market Access and Market Shaping strategies. This will be done in compliance with all appropriate systems, including e-track, the Clinical Trial Register, and Clintrial.gov. Lead the Scientific / Medical partnerships with Key External Stakeholders including Area Scientific Societies, National and Regional Healthcare Authorities and Regional External Experts to leverage GSK ethical / scientific reputation and access to medicines. Direct team-based shared resources and services which enable team to advance the strategic and operational proficiency in clinical development and medical activities e.g. Microbiology, Epidemiology, Health outcomes, SOP/GCP training, etc. Provide oversight to Medical Information functions, and ensure appropriate representation via the Medical Information Network and/or Council.
Key Accountabilities/Responsibilities :
Main Responsibilities Governance Be responsible for integrated governance oversight for team. Support TA Medical Affairs Director in implementation of appropriate Pharmaco-vigilance systems and training. Be responsible for governance in the team for all commercial activities and, risk management of commercial practices. Support TA Medical Affairs Director in implementation of adequate roll out and training of promotional code, relevant Policies and SOP’s, as well as providing guidance in governance issues. Be responsible for Medical Governance oversight during M&A activities; ensure appropriate integration of Governance systems (Pharmacovigilance, Clinical Research, Medical Information, Promotional Code). Provide medical review for all marketing and promotional campaigns, materials and activities, donations and contributions in accordance with the International Marketing and Promotional Code. Ensure appropriate processes are in place to enable compliance, and that breaches and risks are escalated to the MGC. Be responsible for medical review of external communications.
Main Responsibilities – Medical Affairs Drive the Medical Affairs Role to support product commercial goals wrt IP and non-IP products, by providing strategic medical input in pre-launch, launch and lifecycle management activities. Partner with EMAP Therapeutic Heads CoEs to resource activities and provide strategic direction to Regional activities such as: Key Opinion Leader activity Advisory Boards Treatment Guideline Development Patient Interest Groups Publications/Communications Regional Symposia Product Optimisation Plans Provide input to the development and implementation of the medical plan which is consistent with the country business plan for Business Unit. Assess product commercial strategies for designated markets and advice and influence EMAP Therapeutic Heads of ‘key’ Area-specific requirements in global clinical development strategies. In partnership with the BU Manager, provide guidance on proposed promotional activities. Ensure the effective relationship of Medical, Marketing and Regulatory through defined TA matrix teams; contribute to broader International and Regional discussions of key success factors. Develop scientific interactions with external stakeholders: Experts & Scientific Societies, Non Government Organisations (NGOs), Healthcare Authorities, Regulators and payors Drive with the BU Manager an integrated strategy for partnerships with external stakeholders in disease awareness, disease management, education, research and public health that serve GSK reputation and access to medicines.
Main Responsibilities – Market Access Support the optimal access to market for New Chemical Entities (NCEs) as well as new therapeutic indications; ensure provision of appropriate Epidemiological, Clinical and Pharmaco-economic data in a timely manner to expedite pricing and reimbursement processes. Establish and implement a blueprint A-Z process from POC to market entry to ensure World Class execution of Medical and Medico-Marketing activities in support of new product introduction: clinical gap analysis and input into clinical development plans, set up of Advisory Boards, conduct of relevant epidemiological and pharmaco-economic studies and models and interaction with regulators and payors in key markets.
Main Responsibilities – R&D Critically assess and communicate current and future clinical trends to ensure global development decisions are both comprehensive and opportunistic. Provide input and dissemination of Global/Regional strategic and operational activities.
Qualifications/Requirements: (Education / Experience / Competencies)
Knowledge & Experience Medical Master Degree or above in Clinical Medicine Knowledge of clinical development process, and regulatory requirements At least 5-8 years experience in medical practice or industry medical team.
Skills Good command of English (written and spoken); Knowledge of PC (WORD, EXCEL, POWERPOINT); Interpersonal communication skill; Team player Presentation skill Project Management Leadership and people management
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