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Clinical Medical Writer- maternity cover
Posted 6 hours 19 minutes ago by Sanofi EU
Location: Budapest, Hungary
Flexible working: according to local hybrid working policy
Job type: Fixed-term , Full-time
About the jobAre 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
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
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)
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 !
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 EU
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