Mumbai, IND
2 days ago
Investigational Product Manager
**Main responsibilities:** + 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 _Study Setup_ + Identifies & implements efficiencies in IMP/AxMP/MD processes management, including continuous training and creation of quality documents at local and site levels ( _local manual*_ ). + 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. _Study On-Going_ + Manages Importation and Exportation process for all studies (eg - _IMP, AxMP,)._ + Oversees Depot activities ( _Study set-up, receptions, inventory management, shipments scheduled, labeling, returns, destruction, and equipment returned_ ). + Manages quality issues regarding IMP ( _eg - recall, temperature excursions, product technical complaints, local depot issues_ ). + 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 ( _eg – CSMM, CQH, purchase, legal, outsourcing vendors_ ). + 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. _Study Closure_ + 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. + **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 + **Education** : Pharmacist or scientific background + **Languages** : EN **Pursue** **_progress_** **, discover** **_extraordinary_** 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 ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! 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. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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