Vaccine Clinical Documentation Lead

About the job

As a Vaccines Clinical Documentation Lead within our Global Clinical Documentation & Quality organization, as a dynamic leader you will oversee the Vaccine’s Clinical Documentation focused employees in the Budapest Hub.

In this role you will focus on delivering high-quality documentation and ensuring TMF excellence across clinical studies. You will lead the medical writing deliverables, provide strategic direction for TMF management, and be enthusiastic about developing team capabilities.

The core accountabilities include oversight of clinical documentation, medical writing activities, TMF / eTMF quality and completeness, while fostering robust relationships with global stakeholders and functional leads.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale - and shape the future of immunization.

About Sanofi :

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities :

• Oversee the Medical Writing team and activities in the Hub, with commitment to delivering high quality results and overcoming challenges with successful execution
• Oversee the Records Management activities in the Hub, ensuring smooth functioning and overall completeness of the TMF / eTMF
• Act as liaison to global functional leads on business topics such as metrics, prioritization, and performance
• Promote teamwork, quality, operational efficiency, and innovation
• Foster employee development to build subject matter expertise and encourage collaboration with global functions to enhance knowledge sharing and drive process improvements
• Ensure team activities compliance with health authority requirements, Sanofi SOPs, and departmental standards
• 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
• Provide mentorship to staff, manage hiring and training processes, and ensure performance goals are met effectively

About you

Experience :

• At least 3 years’ experience in medical writing of clinical and / or regulatory documents
• Track record of managing teams delivering clinical documentation
• Strong leadership ability coupled with strategic and innovative thinking
• Proven ability to manage changes, negotiate and influence others, and resolve conflict

Knowledge, soft skills and competencies :

• Knowledge of drug development, regulatory or other guidelines pertaining to document standards and submission requirements
• 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)
• Management skills including, but not limited to leadership, prioritization, team inspiration, cross-cultural sensitivity, delegation, empowerment, and accountability

Technical skills :

• Skilled in MS Office Suite
• Knowledge of electronic document management systems

Education :

• Minimum Bachelor’s degree in Life Sciences or equivalent. Advanced degree preferred.

Languages :

• Excellent written and verbal communication skills in English

Why choose us?

• Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology
• Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare
• 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 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.

#Sanofi #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#Sanofi_Budapest_Hub #Budapest

#R&D #recordsmanagement #eTMF #Medicalwriting #clinicaldocumentation #leadership #peoplemanagement #teamlead #clinicaljobs #vaccine

#LI-EUR #LI-hybrid

null