Senior Associate Evidence Synthesis Clinical Outcome Assessments COA

Job Title

Senior 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
• Independently generate evidence 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 (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
• Support the team members in executing the allocated project by acting as SME and guiding the team in execution of the projects driven by robust scientific expertise
• 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
• Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging
  
  

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
  
  

Performance

• (1) Lead and contribute at different levels in execution of assigned Evidence Synthesis projects (including but not limited to search strategy development, screening, data extraction): Lead 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…
• (3) Support development of COA dossier and provide strategic direction
  
  

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
• (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
  
  

About You

• Experience: 5+ 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 to lead and deliver the projects
• 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

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