Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

POSITION DESCRIPTION

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 SGZ Scientific Review Committee (SRC).

The role reports directly to the Sanofi Senior Manager, ESR Operations.

KEY RESPONSIBILITIES INCLUDE

• 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, KPI’s 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 R&D and Local 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.

QUALIFICATIONS

• 3+ years of relevant experience in Medical, regulated pharmaceutical environment, or other relevant experience.

• Bachelor’s education at minimum.

• Project management experience, certification preferred.

• Knowledge of Medical Investigator Sponsored Studies program requirements and understanding of the external environment and regulations that impact the conduct of such programs, including GCP, ICH standards, OIG, PhRMA code, etc. preferred.

• Strong quantitative, analytical (technical and business) and problem-solving skills.

• Strong verbal and written communication skills; proven cross-functional collaboration skill and experience.

• Proven self-starter with experience driving efficiency in processes highly desirable.

CORE COMPETENCIES

• Stretch – to go beyond the level we have operated at up until now:

  • Constantly challenges the status quo to achieve better outcomes

• Focuses on priorities that deliver the best outcomes and stops activities that won’t

• Strives for excellence; does not tolerate mediocrity

• Take Action – instead of waiting to be told what to do:

  • Takes smart and informed risks based on available information, even if it is not 100% complete

  • Makes bold and impactful decisions to move us forward

  • Focuses on what we can constructively do in any situation, despite the constraints

  • Constantly asks how we can take action without waiting for direction

• Act for Change – embrace change and innovation by supporting the evolution of the ESR Operations function, driving improved effectiveness.

• Cooperate Transversally – collaborate effectively with peers, stakeholders and partners across the organization to positively impact ESR program efficiency and execution.

• Strategic Thinking & Decision Making – ability to think broadly and long-term to drive excellence in execution and timely decision making based on information available to support compliant and efficient delivery of study milestones.

• Develop People – take responsibility for self-development to improve performance and positive impact to the organization along with driving individual career progress.

• Commit to Customers – Understand, meet and excel internal and external customer expectations to create positive impact through the evolution of the ESR Operations function.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.