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Externally Sponsored Research Manager

BioSpace

Job Title:Externally Sponsored Research Manager Location: Morristown, NJ About The Job Within Sanofi, we are committed to supporting medically and scientifically sound research aimed at the advancement of disease knowledge and potential treatments in therapeutic areas of interest to Sanofi with the goal of advancing patient care. Sanofi receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for Externally Sponsored Research (ESR) support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC). The ESR Manager is responsible for operational oversight of unsolicited research support requests submitted through the company web portal, to ensure they are appropriately routed for scientific review. This position will ensure timely and compliant study review, start-up, execution, completion, and tracking of key research milestones as per research agreement, for ESR approved by the Scientific Review Committee (SRC). The role reports directly to the Sanofi Senior Manager, ESR Operations. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives. Main Responsibilities Manages the overall study operational activities for all ESRs from initial proposal submission to study closeout including (but not limited to) SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation and cross-reference letters, transfer of value reporting, tracking payments, and overall ESR program reporting. Executes all ESR process-related activities compliantly per Sanofi SOPs, policies & procedures and local laws& regulations. Contributes to program audit readiness and provides accurate and rapid responses to audit inquiries. Collaborates cross-functionally to ensure efficient and timely delivery of research agreements, product supply, purchase orders and other deliverables. Collaborates closely with SRC providing necessary information and support to ensure compliant, timely, efficient reviews of concepts, study outlines, protocols, and protocol amendments. Supports the development of metrics, KPIs and other business analytics to measure progress and inform investment decisions; ensures study updates are collected, documented, tracked, and communicated to stakeholders. Oversees ESR system of record; maintains data integrity by enforcing standards, controls & permissions. Works with system vendor and Systems & Process Ops team on issue resolution and enhancements. Collaborates with Product Supply teams to ensure product demand forecasts are maintained and updated to reflect current needs for adequate supply of active studies. Collaborates and provides information for CMO reporting and cross-GBU initiatives related to ESR. Supports dissemination of safety updates and Dear Investigator Letters (DILs). Ensures stakeholders are trained and have access to ESR system of record and other ESR related tools. About You Basic Qualifications Education: Bachelor's degree in life sciences or a related scientific discipline Experience: Minimum 2 years of relevant experience in clinical operations, hospital settings, pharmaceutical, or another regulated medical environment Preferred Qualifications Project management experience, certification (e.g., PMP) is a plus Familiarity with Investigator Sponsored Studies program requirements and the external regulatory environment (e.g., GCP, ICH standards, compliance codes) Proven track record of driving efficiency in processes Ability to proactively anticipate obstacles and work independently with minimal direction Experience managing diverse stakeholders across different functions and seniority levels Strong verbal and written communication skills Strong quantitative, analytical, and problem-solving skills Proven cross-functional collaboration skills across multiple teams and seniority levels Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. Help improve the lives of millions of people globally by making drug development quicker and more effective. Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr BioSpace

Vacancy posted 4 days ago
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