Talent.com
Bu iş teklifi ülkeniz için geçerli değil.
Investigation Product Manager

Investigation Product Manager

SanofiIstanbul
30+ gün önce
İş tipi
  • Tam zamanlı
İş tanımı
  • The IPM is responsible for overseeing per study allocated the management of Investigational Medicinal Product (IMP) / Auxiliary Medicinal Product (AxMP) / Medical Devices (MD) and other activities associated, to ensure that reception, handling, storage, distribution, reconciliation, returns, and destruction operations are performed on time and under conformance with Sanofi standard and local & international regulations. It is the main point of contact at country level for IMP management.
  • The IPM has responsibilities per study allocated during the study setup, study conduct and study closure
  • Identifies & implements efficiencies in IMP / AxMP / MD processes management, including continuous training and creation of quality documents at local and site levels ().
  • Budgets IMP LCSR per study at country level.
  • Organizes local kick of Meeting per study for monitoring teams oriented to specific doubts for IMP management and accountability and IMP Check list review at IMPACT System.
  • Manages Importation and Exportation process for all studies (eg -
  • Oversees Depot activities ().
  • Manages quality issues regarding IMP ().
  • Ensure the continuity of the local distribution of the IMP / AxMP & Ancillary material for all sites of all studies.
  • Cooperates with internal and external areas at a local and corporate level ().
  • Supports continuously sites participating in the studies for different topics such as TMD uses, temperature excursion management, log accountability filling, and equipment searching.
  • Attends Audits and Inspections for Study internally and from MoH.
  • Performs IRT Reconciliation at country level and destruction coordination with the depot.
  • Organizes Study file and archive per study.
  • Organizes Study Closure at depot level.

    • Education :

    • Pharmacist or scientific field of study in related departments of the universities

      • Languages :

    • Advance level of both Turkish and English

      • Experience :

    • A minimum of 3 years in the Pharmaceutical Industry with at least 2 in IMP management and distribution

      • Soft skills :

    • Excellent oral and written communication skills
    • Negotiation & problem-solving skills
    • Strong ability to analyze data
    • Project management is a plus (experience in working in a project team and in complex environments, dealing with leading international and / or multi-cultural teams)
    • Risk Management orientated
    • Proactive and innovative mindset

      • Technical skills :

    • Strong knowledge in clinical trial management and Clinical Supply chain
    • Thorough understanding of GMP, GCP & GDP
    • In-depth knowledge of Turkey and EU regulations and guidelines applicable to R&D IMP / AxMP / MD management
    • Experience in successful vendor management and oversight
    • Familiar with Sanofi IP management tools & systems is a plus

      • Pursue , discover

      Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different 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, ability or gender identity.

      Watch our and check out our Diversity Equity and Inclusion actions at !