Country Medical Lead, Established Medicines Business

The Country Medical Lead has single point of accountability for strategic and operational medical activities in the assigned medium size country. He/She is responsible for overall governance and medical compliance of the EMB Medical activities in country to ensure quality standards and efficient execution. The CML pro-actively provides medical leadership and medical input in all aspects of EMB products development, enhancing value to ensure successful implementation of medical strategy in compliance with internal SOPs and external regulations and align with company objectives. As such, a good understanding of the therapeutic area, related products knowledge and local clinical research and practice environment is necessary
Medical governance of EMB Country Medical affairs in general
• Acts as general medical representative of Pfizer in the Country for internal and external facing of medical related matters
• Oversees medical compliance standards across business unit and medical functions
• Responsible for the development and management of EMB medical affairs departmental operating plan and budget
• Represent as country medical lead in the Cluster EMB Medical Leadership Team
Key Opinion Leaders (KOLs) Development and Engagement
• Develop strategic relationship/partnerships with KOLs
• Act as an interface between medical and marketing in order to facilitate interaction/partnership with KOLs from medical point of view
• Share KOLs' insight/feedback with country and regional medical/marketing team to strengthen internal strategies
• Provide medical support in Advisory Board Meetings, CMEs, etc.
Medical Alignment with Marketing and Sales
• Work cohesively with marketing team to develop country medico-marketing strategies and ensure implementation of medical plan
• Review and approve promotional material and CEP (Customer Engagement Program) from medical point of viewwhile ensuring promotional compliance standards are met
• Provide medical insights towards development of commercial strategy for EMB portfolio as required
• Provide therapeutic area/product training to sales representatives as required
• Provide medical support in formulary listing process from medical point of view
People management
• Develop strong Medical team with bench strength, good succession and development planning
• Strengthen Medical Team by building team and developing colleagues and to develop new capabilities to address current skill gaps
Clinical Research
• Play a pro-active role in identifying and developing research strategies and opportunities that optimally support defined TA (Therapeutic Area)
• Review and approve local research proposal such as IIR (Investigator Initiated Research), research grant, educational grant, etc. according to the relevant SOPs (Standard Operating Procedures)
Health Outcomes
• Provide medical guidance on the development and implementation of local research programs including pharmacoeconomics studies, outcomes research, and health technology assessment for the TA
• Provide direction and local needs on the development of health outcomes strategy as required
• Provide medical input and review of data for submission to relevant body as required
Regulatory Affairs
• Provide medical support during the process of product registration/new indication approval in the country as required
• Review and approve LPD (Local Product Document) and PI (Package Insert) of assigned products in accordance with the corporate and local regulatory requirements as required
Medical Information
• Work closely with local medical information team and EMB regional/global medical team to respond to unsolicited medical request as required
Reporting of Spontaneous Adverse Events
• Report adverse events according to local and global guideline in response to written or verbal information including local publication
• Ensure the correct reporting format to Brazil regulators is used in accordance with criteria and guidelines
• Provide medical support to follow up adverse event cases as required
• Ensure full compliance to all local, global and international safety reporting requirements
Regulatory/Legislative Monitoring
• Maintain a current awareness of regulatory development, both locally and internationally to ensure Pfizer is addressing relevant requirements
Government and Corporate Affairs
• Facilitate the interactive communication between KOLs, academic societies and Pfizer
• Provide medical input in review of local Press Release