Job Title: Investigational Product Manager (IPM)
Location: Mumbai, India
Job Type: Permanent
Date Posted: January 24, 2025
Application Deadline: February 28, 2025
About the Job:
Sanofi is seeking an experienced Investigational Product Manager (IPM) to manage all aspects of Investigational Medicinal Product (IMP), Auxiliary Medicinal Product (AxMP), and Medical Devices (MD) management. As the primary point of contact at the country level, the IPM will ensure seamless operations for reception, handling, storage, distribution, reconciliation, returns, and destruction, adhering to Sanofi standards and local and international regulations.
Key Responsibilities:
Study Setup:
Identify and implement efficiencies in IMP/AxMP/MD processes, including continuous training and creation of local manuals and quality documents.
Develop and manage IMP Local Clinical Study Report (LCSR) budgets at the country level.
Organize local kick-off meetings for monitoring teams, addressing IMP management questions and reviewing IMP checklists within the IMPACT system.
Ongoing Study Management:
Manage import and export processes for IMP, AxMP, and related materials.
Oversee depot activities, including study setup, receptions, inventory management, shipment scheduling, labeling, returns, destruction, and equipment returns.
Handle quality issues related to IMP, including recalls, temperature excursions, product technical complaints, and local depot issues.
Ensure continuous local distribution of IMP/AxMP and ancillary materials for all study sites.
Collaborate with internal and external stakeholders, including Clinical Supplies Management, Quality Assurance, Purchasing, Legal, and Outsourcing teams.
Provide ongoing support to study sites, including TMD usage, temperature excursion management, accountability log maintenance, and equipment tracking.
Prepare for internal and external audits and inspections, including those by the Ministry of Health (MoH).
Study Closure:
Perform Interactive Response Technology (IRT) reconciliation and coordinate destruction activities with the depot.
Organize study files and archives per study.
Manage study closure activities at the depot level.
Qualifications:
Education:
Pharmacist or scientific background required.
Experience:
Minimum of 3 years in the pharmaceutical industry, with at least 2 years focused on IMP management and distribution.
Experience in successful vendor management and oversight.
Technical Skills:
Strong knowledge of clinical trial management and clinical supply chain processes.
Thorough understanding of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP).
In-depth knowledge of Indian, Turkish, and EU regulations and guidelines applicable to R&D IMP/AxMP/MD management.
Familiarity with Sanofi IP management tools and systems is a plus.
Key Competencies:
Soft Skills:
Excellent oral and written communication skills.
Strong negotiation and problem-solving abilities.
Proficiency in data analysis.
Project management experience in complex environments with international and multicultural teams is a plus.
Risk management expertise with a proactive and innovative mindset.
Language:
Fluent in English (verbal and written).
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Birmingham |Alaska :
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New Hampshire |Ohio :
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Mitte |Brandenburg :
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Rostock |Munich :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Ringaskiddy |County Dublin :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Capital of Netherland :
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Austria |Vienna :
Vienna |Antwerp :
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Brussels |Flemish Brabant :
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Sofia |Canada :
Canada |Ontario :
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Croatia |Zagreb :
Zagreb |Bohemia :
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Sheffield |United Kingdom :
Harlow | England | United Kingdom | London | Leeds | Maidenhead | Stevenage | Salt Lake City | Stirling |Estonia :
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North Ostrobothnia :
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Yavne | Be'Er Sheva | Netanya | Kfar Saba | Tel Aviv |Italy :
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Rho |Japan :
Japan |Tokyo :
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Remote Korea |Republic of Korea :
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Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Manila |Mazovia :
Warsaw |Remote :
Remote, USA | Switzerland | Remote - South America (Latin Americal) | Remote - Middle East | Remote - Africa | Remote - Europe | Remote |Bucharest :
Bucharest |Makkah :
Rabigh | Riyadh | Jeddah | Khulais | Najran | King Abdullah Economic City |Nišava District :
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Midrand | South Africa |Brazil :
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Taipei |Williamson :
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Ho Chi Minh City |