Medical Advisor - Rare disease

• Medical StrategyDevelopment /Policyshaping 

• To develop and lead the implementation of the medical strategy for the Business Unit (BU) across diverse therapeutic areas.  

• Provide medical support towards business development and new product launches. Will be ultimately accountable for the medical and regulatory strategy to support BD and new launches for the concerned BU. 

• Liase and engage with key external stakeholders such as Key opinion leaders, medical / HCP associations and regulatory bodies for advocacy and relationship building in alignment with Pfizer policies. 

• Customer Engagement and Insight Generation to close the gap in unmet medical needs, through facilitating local guideline/policy update and implementation  

• Establishes the engagement with external stakeholders such as medical/ HCP societies, academic institutions and opinion leaders including   government (MOH, FDA, policy makers, etc.), to bridge Pfizer’s business goals with the external healthcare environment. 

• Focuses on Insight generation through the customerengagements(country stakeholders) and translate these into medical strategies to meet the needs of customers.  He/she will collect, analyze and report local customer medical insights to assist business decision making and will report local competitive intelligence in clinical research and medical positioning and share internally and externally as post-meeting deliverables. 

• Conduct advisory board meetings with different stakeholders as needed, to gain insights for key strategic value adding programs 

• Stakeholder focus to improve quality patient care through partnerships in continuing medical education and capability development in healthcare professionals 

• Develops key partnerships. The Medical Advisor develops partnerships with country stakeholders (such as medical societies, government, academic institutions, KOLs)  to implement key programs to improve the quality of healthcare.  

• Support channel initiativesand support country  access initiatives. 

• Collaborate with commercial and other colleagues to actively support business strategies, particularly those that support priority stakeholders 

• Data Generation for shaping healthcare policy and for regulatory compliance. 

• The Medical Advisor helps in the development and implementation of local data generation programs and other research programs, including but not limited to, real-world data generation and  outcomes research that will support initiatives for  health policy development, guideline development and other TA/channel initiatives in the country to facilitate scientific decision making in healthcare coverage and patient access. 

• To implement regulatory data generation requirements (eg. NIS, Post-marketing surveillance studies  and other clinical trials for regulatory submissions) 

• Medical Operational and Compliance Oversight  

• Periodic review of the quality / outcomes of medically driven programs  

• Provide inputs to the New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products (e.g., licensing, acquiring, co-promotion, etc.) for the assigned BU/cluster of TAs.) 

• Wherever required should also provide subject matter expertise to cross geography medical projects such as digital strategy in medical education, health outcomes research etc 

• Be accountable for complying to all local policies, procedures and regulations for self in all activities relevant to the medical BU 

• Early Pipeline responsibilities 

• Assist in planning, organizing, and preparing Investigational New Drug Applications (NDAs) 

• Develop and execute evidence generation (clinical studies and publications) plan for the pipeline assets; review/approve/write manuscripts for local/regional/global publications and locally sponsored studies 

• For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to “prepare” internal and external stakeholders for commercialization. These include assistance with market research, stakeholder mapping, and early access programs 

• Support New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on commercial opportunities with new products (e.g., licensing, acquiring, co-promotion, etc.) 

• Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication. 

• Write, revise, and review labeling documents for pipeline/local products per relevant SOPs 

• Identify key external stakeholders relevant for the pipeline product/Indication to explore the therapy areas and gather related insight  

• Work cross functionally on country strategy partnering with other key functions such as: Clinical Development, Commercial, Evidence and Value Development, Market Access, Patient Advocacy, and Regulatory Affairs and global teams  

• Contribute to Target Product Profile (TPP) and Study Designs/variables 

• Provide balanced medical information about our pipeline assets to both internal and external customers on request and in a timely manner 

• Provide medical support for clinical development activities and represent India requirements for study designs of drugs in the pipeline  

• Identifying new opportunities for research & development collaborations with leading institutions and external experts 

REQUIRED SKILL SET  

• Medical Degree, Degree in Sciences or Medical Sciences (e.g. Pharmacy, Nursing, Medical Technology, Psychology and other allied health disciplines.) 

• Previous experience in medical affairs, clinical affairs or regulatory affairs in the pharmaceutical industry preferred 

• Degree in advanced sciences or post-graduate courses preferred  

• Good medical and scientific background 

• Proficiency in English and good computer usage