Job Description

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. 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 . 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. 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 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, 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. Interpersonal skills, internal & external networking and the ability to impact and influence Education Postgraduates in Medicine Experience minimum 3 years of medico marketing experience with preferable oncology experience. Work Location Assignment:On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical #LI-PFE

foundit