• Location:  Budapest, Hungary
• Job type: Permanent, Full time
  

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 Sciences and Operation (CSO)’s Clinical Documentation department as Records & Translation Management Lead and you will oversee the Trial Master File (TMF) Managers and Clinical Translation Services Project Managers in Sanofi’s Budapest Hub. Core accountabilities include the oversight of TMF/eTMF archival and completion monitoring, timely delivery of certified translations of submission documents from 3rd party providers.

Your commitment and enthusiasm about people development and adept at fostering robust relationships with global functional leads will be desired.

Main responsibilities:

• Oversee the Records Management activities ensuring smooth functioning and overall completeness of the TMF / eTMF.
• Oversee the Clinical Translation Services activities ensuring the project managers are effectively managing timely deliverables from 3rd party language service providers.
• Act as liaison to global functional leads on business topics such as metrics, prioritization, and performance.
• Provide mentorship, manage hiring and training processes, and ensure performance goals are met effectively.
• Foster employee development to build subject matter expertise and encourage collaboration with global functions to enhance knowledge sharing and drive process improvements. Promote teamwork, quality, operational efficiency, and innovation. 
• Stay updated on evolving industry practices and regulatory requirements to maintain industry leadership. Foster a change-agile environment and act as key change agent for new processes and technologies.
• Manage budgets and oversee initiatives to support legal requests, mergers, audits, inspections, and other organizational needs.

About you

Experience:

• Min. 3-5 years of industry experience, including building and leading teams in a matrix environment.
• Working knowledge of drug laws, regulations, and guidelines. Familiarity with drug development, regulatory or other guidelines pertaining to document standards and submission requirements are advantageous.
• Organizational and process change management experience.
  

Technical skills:

• Strong computer software skills- MS Office Suite.
• Knowledge of electronic document management systems would be preferred.

Soft skills:

• Strong management skills including leadership, prioritization, team inspiration, cross-cultural sensitivity, delegation, empowerment, and accountability coupled with strategic and innovative thinking.
• Proven ability to manage changes, negotiate and influence others, and resolve conflict.
• Understanding of business considerations (basic finance, human resources).
• Ability to adapt to needs of an evolving business environment (e.g., regulatory requirements, corporate structure and processes, customer focus, technological advances).
• Ability to work across time zones and cultures.

Education:

• At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience.
  

Languages:

• Fluency in English, oral 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. DiscoverExtraordinary.

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, 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.

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