Early Pipeline Medical Advisor

4 months ago

Mumbai, India Pfizer Full time

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 expert
- 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.
- 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.
- 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
- Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical

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