Junior Associate - Evidence Synthesis, Clinical Outcome assessments (COA)

Job description

Job title: Junior Associate – Evidence Synthesis: Clinical Outcome Assessment (COA)   • Hiring Manager: Head/Group Lead//Team Lead/Manager • Location: Hyderabad • % of travel expected: Travel required as per business need • Job type: Permanent and Full time     About the job About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.   Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, Consumer Health Care (CHC), Chief Medical Officer (CMO) and Research and Development (R&D), and Data & Digital functions​. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, R&D, Health Economics and Value Assessment (HEVA), and Commercial organizations​ in Sanofi, globally.   About the Job: The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients’ perspective (and other subjective perspectives) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods. The Global COA team is part of Sanofi’s Global Research and Development (R&D), and reports into the Patient Driven Medicines Development (PDMD) department. The COA evidence generation team from Hyderabad hub will diligently work with PDMD and support the team in evidence generation for making strategic decisions. The evidence generation activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties for a COA instruments; support in the development and validation of new COA instruments; support in development of briefing books or dossiers for regulatory consideration of COAs, etc. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We are also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?   Main responsibilities: The overall purpose and main responsibilities are listed below: Assist at different levels in execution of assigned Evidence Synthesis projects (including but not limited to search strategy development, screening, data extraction) to generate robust evidence to maximize the value propositions in support of programs/products for Global/Local markets • Generate a comprehensive understanding of a disease and treatment paradigm through secondary research • Generate evidence in collaboration with senior team members in support of the use and/or development of Fit-for-Purpose COA instruments in clinical research projects: including gap analyses, implementation, statistical analyses, psychometric validation and dissemination • Prepare the scientific documents in collaboration with senior team members (reports, regulatory documents, publications, etc.) for internal and external communication • Contribute to a successful strategy for innovative products by an optimized COA endpoint strategy aligned with Sanofi’s Best in Class/First In Class approach • Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging • Seek opportunities to innovate, COA value identification, evidence generation and dissemination process/plan to increase the relevance and impact of COA on regulatory and reimbursement decision making   Maintain adherence to the evidence generation guidelines and other standards relevant to COA evidence generation processes Develop and maintain expertise People: • (1) Support the internal Sanofi Global Hub COA team in effective delivery of evidence generation projects Performance: • (1) Assist at different levels in execution of assigned Evidence Synthesis projects (including but not limited to search strategy development, screening, data extraction): Support activities for research plan which includes literature reviews, Qualitative research, COA landscape analysis, development and analysis of COAs; Provide support with individuals and institutions, which may serve as resources for evidence generation purpose, etc. • (2) Supports the COA lead to manage and execute research studies associated with COA strategy development; Studies include but are not limited to literature reviews, qualitative research which includes but not limited to elicitation of patient experience and preference, validation of COA instruments etc… in collaboration with the senior team members Process: • (1) Assist in development of COA strategic evidence generation processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with regulatory guidelines (FDA and EMA) and COA contributions as appropriate to other submissions in collaboration with the senior team members • (2) Ma