• Job title: Clinical Documentation and Quality Lead, R&D Hub Budapest
• Location: Budapest
• Flexible working: 60% home, 40% office
• 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.

Join our global Clinical Documentation and Quality team as Clinical Documentation and Quality Lead and in this leadership role you will oversee clinical documentation and quality activities aligned with the Global R&D Hub, ensuring high-quality submissions and inspection readiness. You will play a pivotal role in driving strategic initiatives that support the growth and evolution of the Hub, focusing on optimizing processes and enhancing efficiency. Accountabilities include, but are not limited to, medical writing, trial transparency, translations, records and quality document management, and training compliance.

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?

Main responsibilities:

• Lead the Hub Clinical Documentation and Quality activities, with commitment to delivering high quality results and overcoming challenges with successful execution.
• Act as liaison to global functional heads on business topics such as metrics, prioritization, and performance.
• Develop team leaders and employees to enhance skills and promote collaboration across functions, optimizing resource allocation.
• Implement technology and process improvements to streamline document preparation and reduce costs effectively.
• Stay updated on evolving medical writing practices, regulatory and inspection readiness requirements to maintain industry leadership.
• Manage budgets and oversee initiatives to support legal requests, mergers, audits, inspections, and other organizational needs.
• Provide mentorship to staff, managing hiring and training processes, and ensuring performance goals are met effectively.

About you

Experience:

• At least 5 years of industry experience, including building and managing teams.
• Working knowledge of drug development, laws, regulatory or other guidelines pertaining to document standards and submission requirements.
• Project and/or clinical operations management experience in a global environment.
• Collaborative experience with external partners providing resources or expertise (CROs, Consultants, Experts).

Soft skills:

• Management skills including, but not limited to 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) with the ability to adapt to needs of an evolving business environment (eg, regulatory requirements, corporate structure and processes, customer focus, technological advances,).
• Diplomacy, negotiation skills, and ability to network.
• Ability to work across time zones and cultures.

Technical skills:

• Good knowledge of MS Office Suite (Word, Excel, PowerPoint)
• Knowledge of electronic document management systems and resource planning

Education: At least a bachelor’s degree, or equivalent, in life sciences, or related areas of study, and relevant experience.

Languages: Fluency in English (written and spoken).

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)

PursueProgress. 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 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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