Pfizer Looking For Medical Advisor at Mumbai, Maharashtra, Full Time

• Medical Strategy Development/Policy shaping
• To develop and lead the implementation of the medical strategy for the entire BU across diverse therapeutic areas.
• Lead the 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.
• Liaise 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 updates and implementation
• Establishes the engagement with external stakeholders such as medical/ HCP societies, academic institutions, and opinion leaders including government (MOH, FDA, policymakers, etc.), to bridge Pfizer’s business goals with the external healthcare environment.
• Focuses on Insight generation through the customer engagements (country stakeholders) and translates 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.
• The Medical Advisor will also 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 initiatives and support country access initiatives.
• Collaborate with commercial and other colleagues to actively support business strategies, particularly those that support priority stakeholders
• The Medical Advisor develops advocates and key opinion leaders among the key customers and stakeholders of the company to support the business needs.

Data Generation for shaping healthcare policy and for regulatory compliance.

• The Medical Advisor leads 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)
• In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e.g., investigators’ brochure (IB), informed consent form (ICF), patient information sheets, etc) for, Phase IV, PMS, Observational studies/surveys,
• Pharmacoeconomic / Outcomes Research studies, and other clinical projects/programs. In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc
• Review/interpret data generated; write final reports for locally sponsored studies as required and review/approve/write manuscripts for publication of locally sponsored studies.

Medical Operational and Compliance Oversight

• Budget planning, prioritization and tracking for all medical projects for the concerned BU
• Review and approve the research proposals (IIRs) and medical projects for the concerned BU in alignment with the overall medical/business strategy
• Review and approve the publication plan for all locally sponsored studies/review articles for the concerned BU.
• Periodic review of the quality/outcomes of medically driven programs and take appropriate decisions to modify/amend in alignment with commercial BU leaders.
• Lead the exercise towards portfolio evaluation at a regular interval and 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 ultimately accountable for complying to all local policies, procedures and regulations for self and team in all activities relevant to the entire medical BU
• Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies
• Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives and provide pre-launch and launch training to sales staff for new products

Regulatory

• Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through the delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
• Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
• Write, revise, and review labeling documents for pipeline/local products per relevant SOPs
• Provide medical support towards the processing of spontaneous/solicited AE reports, per relevant SOPs and/or working practices

Required Skill Set

• Medical Degree, Degree in Sciences or Medical Sciences (e.g. Pharmacy, Microbiology, etc) MD Pharmacology / MBBS
• Candidates with previous experience in therapy areas
• Previous experience in medical affairs, clinical affairs or regulatory affairs in the pharmaceutical industry preferred
• Good medical and scientific background
• Proficiency in English and good computer usage

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical