Job responsibilities:
- To actively contribute to the organization/business unit (BU)/TA cluster by taking responsibility for the scientific, technical and ethical soundness of all policies, statements and endeavors. To lead the BU medical team in all activities medically related to the allocated Pfizer Business Unit portfolio and provide high quality and timely service in the areas of medical initiatives/support to the assigned portfolio, Interactions with Healthcare Professionals, Continuing Medical Education, Clinical Research, Sales Force Training, Medical Information, and Performance/People Management, and support in the areas of New Product Development/ Branded Value Offerings, Regulatory Affairs, Quality Standards, and Business Technology
- A. Strategic/Policy:
- Provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed
B. Operational: - Medical Initiatives/support for the Allocated Portfolio (New/Key Detail/In-line Products)
- Provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines
- Initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices
- Participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc.
C. Clinical Research : - 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.
- Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs)
- Review/interpret data generated; write final reports for locally sponsored studies as required
- Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies
- Develop and execute Information Dissemination Plan/Program
- Medical Information
- Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies
- Provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed
D. Sales Force Training:
- Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives
- Provide pre-launch and launch training to sales staff for new products
E. New Product Planning/Development: - For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to “prepare” internal and external stakeholders for new product launches. 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 opportunities to launch new products (e.g., licensing, acquiring, co-promotion, etc.)
- Support organization efforts at developing local formulations/line extensions through literature search/recommendations. Function as custodian for coordinating internal and regional approvals through the RFD (Request For Development) process
F. Regulatory:
- 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
Apply: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/jobs/details/Medical-advisor–Oncology_4927064-1?q=clinical%20research&locations=e2d3979e3af