OneMain Financial Jobs

• Job title: Investigational Product Manager

• Location: Budapest, Hungary

• Job type: Permanent, full-time

• Hybrid working (60% office, 40% home)

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our global Clinical Supply Chain Operations (CSCO) team as an Investigational Product Manager and you'll oversee end-to-end management of Investigational Medicinal Products (IMP), Auxiliary Medicinal Products (AxMP), and Medical Devices (MD) within our HUB model. Operating within Clinical Supply Chain Operations (CSCO), you'll ensure the global supply of investigational products to study participants worldwide, serving as the primary country contact for all IMP-related matters across your assigned studies.

Main responsibilities:

Study Setup and Implementation

• Identify and implement efficiency gains in the management of IMP/AxMP/MD processes

• Assist Global Regulatory Affaris with CTA documentation related to product imports in accordance with country requirements (if applicable)

• Support CSU and local study teams in creating budgets related to IMP activities

• Participate in national and study meetings to provide expertise in IMP management

Management of Imports and Exports

• Supervise the import and export process for all studies

• Manage additional import submissions to the relevant agencies

Vendor Management (local/regional depots and local service provider)

• Coordinate study set up, local procurement, receipts, and shipments

• Manage inventory, additional labeling, returns, and destruction

Quality and Issue Management

• Manage study IMP quality issues with dedicated quality contact (e.g., recall, product technical complaint, local depot event)

• Support the monitoring team for product-related topics such as storage equipment issues, temperature excursion management, and any other product-related issues resolution

• Involve in deviation and change control management follow-up activities

Coordination and Communication

• Cross-functional cooperation with internal departments and vendors at local and corporate level

• Interact with ISS & the Investigational Product Support (IPS) Hub teams to ensure smooth management of dedicated activities

• May be assigned as Country Point of Contact for a country of reference, serving as the primary liaison and overseeing country-related IMP management activities and processes

Compliance and Audits

• Participate in audits and inspections for dedicated studies and the CSU system

• Support and attend local vendor audits with the assigned auditor

Study Closure

• Organize reconciliation at the country level and coordinate destruction

• Manage IMP study file archiving

• Ensure study data closure in all CSCO systems

Training and Documentation

• Ensure that documentation on the IMP management processes at country level is updated

• Provide the required additional training to the local monitoring team on IMP/AxMP/MD processes on an ongoing basis

About you

Experience:

• A minimum of 3 years in the Pharmaceutical, healthcare, or logistic environment

• Experience in IMP management and in clinical trials distribution is a plus

Soft Skills:

• Strong oral and written communication skills

• Analytical approach to resolving challenges

• Ability to reach agreements with stakeholders

• Taking initiative and anticipating needs

• Working effectively with international and multi-cultural teams

• Anticipating and mitigating potential issues

Technical skills:

• GxP knowledge

• Understanding of supply chain in clinical trial context & management of products from study set up to reconciliation

• Ability to interpret and analyze digital data

• Experience in vendor oversight and management of invoices

Education:

• University degree in Scientific or logistic field

Language(s):

• Strong English skills (verbal and written), ability to exchange fluently in a global environment

• Strong German skills (verbal and written)

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment

• Work from an "Office of the Year 2023" award winner with flexible home office policy

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks

• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue Progress . Discover Extraordinary .

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, 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) !

Discover our Code of Conduct (https://www.codeofconduct.sanofi/) , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

#Sanofi #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#SanofiBudapestHub #Budapest

#R&D #LI-EUR #LI-hybrid

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) !

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

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)