RWE Study and Operations Lead

Job title: RWE Operations & Study Lead

• • Hiring Manager: Head, Scientific communications
  • Location: Hyderabad,
  • % of travel expected: Travel required as per business need
  • Job type: Permanent and Full time

About the job

Our Team:

Sanofi Business Operations is an internal Sanofi resource organization based in India, Hungary and Spain and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and

functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally.

Main responsibilities:

To provide program/project management expertise and operational support for Real-world evidence studies and projects undertaken by the SBO RWE team; To help implement and manage solutions for an innovative and rapidly growing team of RWE experts, data scientists, methodologists, and data analysts, and to help create an efficient and impactful delivery engine; Drive the execution and delivery of RWE solutions, including project/study team design, project/study monitoring, and play an important role in operational and project budget planning; To be familiar with the details of all prioritized RWE studies and projects, and work as a member of Study/Project Teams to ensure that they are closely monitored to identify risks that can be mitigated, allowing projects to be completed on time and on budget; To ensure smooth day-to-day operation of RWE Project/Studies, help to resolve program issues, and facilitate alignment within sub-teams and, as necessary, provide critical interface between cross-functional stakeholders. To provide support to the Global Head of Real World Data and Evidence Science leader on critical initiatives that advance the

impact of RWE within and outside Sanofi.

• • People/Performance/Process: (1) Provide operational leadership of RWE projects and studies; design and implements solutions that support project and study management (including milestones and budgeting), ensuring that the RWE portfolio is managed efficiently and that solutions are delivered on time and on budget; (2) Design and implement a crisp and clear operational process that supports RWE objectives and enable it to drive impact across the GBU; find ways to streamline execution of projects/studies, proactively identifying issues and proposing mitigations plans when needed; (3) Form Study Teams, organize and facilitate kick off meetings, and ensure that work-steps and compliance documentation (Study Outline, Protocols, etc.) are completed on time/on budget; (4) Help research non-platform data sources and confirm vendor capacity to meet RWE team needs; (5) Provide critical interface between the Global RWE team and MedsOps during the FM2 and MMC activities, and support routine prioritization, reporting, and budgeting exercises; (6) Provide critical interface between the Global RWE team and the SBO Hub or external vendors and project teams; (7) Maintain accurate and current project/study tracker (reflecting prioritized RWE activities for MAx, Medical, and Commercial teams), and ensure that every prioritized initiative has an eSTRA or SmartSheet identifier; provide project owner and key stakeholders with regular updates on portfolio health, and flags issues/risks; (8) Prepare for pre-MPB and MPB meetings, highlighting projects/studies at risk; (9) Manage interface with procurement and contacting, and ensure that contracts are in place before project begin; (10) Lead and partner in the development and maintenance of project timelines and associated budgets to ensure project and action item completion; (11) Lead and closely monitors cross-functional work-streams to ensure integration and prioritization of activities; (12) Oversee the RWE budget, identifying and managing variances, and addressing strategic resource re-allocation/budget challenges to ensure accurate forecasting and expense recognition; support cross-charge process with SBO Hub; (13) Provide analyses of projects to proactively identify potential risks or efficiencies; identify issues and propose mitigation plan; (14) Facilitate positive interactions with internal stakeholders and external partners, including KOLs, data producers, and third-party vendors (15) support the management and the effectiveness of the SBO Operational team and support the continuous management, hiring and performance of

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• the SBO teams in Hyderabad, Budapest and Barcelona. (16) Develop and implement initiativesaiming towards the modernization and building a data -driven approach for Evidence generation by supporting the following activities: coordinate with the vendors the initiative on the continued Evidence Intelligence activities of monitoring the use of RWE by regulators, payers in their decision making, coordinate the development of an RWE training and awareness strategy (ex: monthly webinars, annual RWE summit, etc) not only for the Global functions but also to support the RWE affiliate training efforts,

About you

• • Experience: Overall 10 plus years’ experience with 3-5 years of experience in expanding roles in operations roles supporting clinical research or a closely related field, including the current environment (pharmaceutical, vendor, R&D environment, CRO); Knowledge of real-world evidence and real world data; Ability to track a wide range of parallel activities and to hold stakeholders accountable to meet timelines; Expertise in supporting and managing end-to-end large and complex projects, budget management and oversight, and in managing cross functional teams; Experience providing oversight and coaching; Expertise in project management with a delivery mindset and highly detail-oriented
  • Soft skills: Excellent written and oral communication; Excellent organizational and project management; Ability to facilitate complex discussions with a wide range of stakeholders; Warm, friendly, upbeat, can-do profile with a desire to take on complex tasks and help drive innovation; Ability to network and communicate across diverse functions to gain consensus and clear actions; Critical thinking - ability to challenge the status quo with strong problem-solving skills; Anticipate risks and propose mitigation plans; Influencing skills to motivate team members and external stakeholders for best performance and outcomes
  • Education: Degree in a scientific discipline (e.g., BS, MS, PhD, PharmD) or a related degree, with substantial project management or RWE/RWD experience
  • Languages: Excellent knowledge of English language (spoken and written)