Location: Budapest, Hungary

Flexible working: according to local hybrid working policy

Job type: Fixed-term , 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 subgroup as Medical Writer (MW) and you will be an essential team member to produce high-quality clinical documents (content and format), including submission activities. We are involved in all clinical document preparation steps, while ensuring that the content conveys the scientific medical information with consistency. You will oversee operational oversight of CRO outsourced deliverables: to guarantee content quality and adherence to Sanofi quality standards.

Medical Writers work cross-functionally with multiple development functions (for ex. Clinicians, Biostatistics, Regulatory, Pharmacovigilance) or partners (for eg. CROs) and within multiples therapeutic areas or with development partner companies. Medical writing skills are also required for the development or validation of digital writing tools, using artificial intelligence.

Please note this is a Fixed-term, maternity cover position until cca. 31st December 2026.

Main responsibilities:

This is a position for an entry level medical writer who can take responsibility for the preparation of clinical documents:

• Study protocols of low or medium complexity

• Clinical Study reports of low or medium complexity

• Package preparation for P70 and Health Canada dossiers

• Coordination of narrative production

• Operational oversight for P70 and Health Canada dossiers, lay summary results, Phase 1 and Phase 4 protocols, redacted documents

Key activities for the document preparation include:

• Writing, summarizing, editing of documents

• Coordinating different functions contributing for a given deliverable

• Defining or proposing timelines and ensuring that timelines and quality control performed per defined process

• Organizing team reviews including comment resolutions meeting and implementation of comments for all assigned documents

About you

Experience:

• Experience as a medical writer (or equivalent) or presenting relevant specialist qualifications

• Background documenting a basic understanding of, preferably also experience in basic statistics and clinical research

• Knowledge of clinical development processes is preferred
  

Technical skills:

• Technical comfort with electronic document management and word processing software is required, particularly good with Microsoft Word, Excel and PowerPoint

• Knowledge / experience on Artificial Intelligence is advantageous

Soft skills:

• Excellent interpersonal skills

• Ability to work in an accurate, meticulous manner; is detail- and deadline oriented

• Possesses a solid work ethic, professionalism, organizational and follow-up skills

• Ability to interact with a variety of personalities and to work effectively in an international environment

• Adaptable to changes in priorities, working on multiple projects simultaneously, while maintaining priorities and high-quality results

Education:

• Scientific advanced degree, a Ph.D. in life sciences, PharmD, or medically qualified or with equivalent relevant experience

Languages:

• Fluency in English, including understanding of English language usage and also standardized writing styles 

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 2024" 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.DiscoverExtraordinary.

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, gender identity or Veteran status.

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

#clinicalsciencesoperations

#medicalwriter

#medicalwriting

#regulatorywriting

#LI-EUR #LI-hybrid