**Job title** **:** **Associate – Evidence Synthesis: Clinical Outcome Assessments (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, 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-Informed Development & Health Value Translation (PID&HVT) department. The COA evidence generation team from Hyderabad hub will diligently work with PID & HVT 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 of 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:** Contribute 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 primary and 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 product 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 Clinical Outcome Assessment (COA) value identification, evidence generation and dissemination process/plan to increase the relevance and impact of COA on regulatory and reimbursement decision making_ _Develop and maintain expertise_ People: (1) Support and maintain effective relationships with key stakeholders (2) Work effectively with COA leads across the globe at various time zones along with the senior team members Performance: (1) Contribute 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) Support execution of and manage ongoing study(s) if required: 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 (3) Support development of COA dossier and provide strategic direction in collaboration with the senior team members Process: (1) Contribute to 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) Maintain adherence to the evidence generation guidelines and other standards relevant to evidence generation processes Stakeholder: (1) Work with COA, HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs and Market Access global or local teams in regions/areas to identify evidence generation and dissemination needs and assist in developing assigned deliverables (2) Assist COA team to prepare relevant & customized deliverables for these Teams (3) Support development of COA dossier and provide strategic direction in collaboration with the senior team members **About you** + **Experience** : _3+ years of experience in COA science such as COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation for the pharmaceuticals industry, CRO consultancy or academia._ + **Soft skills** : _Stakeholder management; writing/communication skills; external engagement and ability to work independently and within a team environment._ + **Technical skills** : Strong analytical skills to synthesis qualitative and quantitative data and to translate COA information and key messages into evidence strategies. + **Languages** : _Exceptional knowledge of English language (spoken and written)_ **Pursue progress, discover extraordinary!** Better is out there. Better medications, better outcomes, better science. But progress does not happen without people – people from diverse backgrounds, in distinct locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)