Sanofi Group Trial Supply Operations Manager, Bridgewater, NJ in Bridgewater, New Jersey

The role of TSOM is to perform study set-up and follow-up tasks related to Clinical Supply Chain Operations (CSCO). The TSOM is leading the study at CSCO

He or she is the key contact for CTOMs in charge of the study.

  • Receives the ES/protocol, comments and contributes on IMP/NIMP sections

  • Captures the requirements (countries list, recruitment curveā€¦) in order to translate the ES into:

  • IMP/NIMP/Devices forecasts

  • Packaging specifications with the CSPM,

  • IP/ancillaries and/or devices needs,

  • Survey to define strategy for supplying comparators and ancillaries,

  • Distribution specifications and strategy depending on participating countries

  • Manages the study risks and appropriate mitigation plans

  • Set-up IRT if needed.

  • Provides Documentation input: protocol/monitoring plan/Pharmacy manual/Instructions for Use/ CRA presentations

  • Initiates label process (form1) and supports addition labeling process when needed

  • Manages treatment list.

  • Generates master study plans for packaging and distribution

  • Monitors the variance between realization versus forecast and adapt the master study plans

  • Supervises TSOM support activities

Required skills

  • BAC+5 (Engineer or equivalent)

  • 2-3 years of experience in Pharmaceutical Industry

  • Experience in Supply Chain

  • Ability to work under tight deadline

  • A good relational sense,

  • Teamwork,

  • Strong organization skill,

  • Work autonomously

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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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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life