Medical Writer (Budapest)

Medical Writer (Budapest)
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About the job

Our Team:

Medical Writers (MW) are essential team members to produce high-quality clinical documents (content and format), including submission activities. We operate within CSO (Clinical Sciences and Operations)-Clinical Documentation subgroup.

We are involved in all clinical document preparation steps, while ensuring that the content conveys the scientific medical information with consistency. MWs are also involved in operational oversight of CRO outsourced deliverables: to guarantee content quality and adherence to Sanofi quality standards.

MWs 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.

Medical Writer

Main responsibilities:

This is a position for medical writers 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 with, basic statistics, experimental research and clinical development process
  • Knowledge or interest on Artificial Intelligence

Technical skills:

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

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, or medically qualified, or with equivalent relevant experience

Languages:

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

When joining our team, you will experience

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
  • An attractive, market-oriented salary and cafeteria benefits
  • Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
  • Work from an "Office of the Year 2020" finalist office
  • Collective life and accident insurance
  • Yearly medical check-up
  • Exposure to training and certification pathways for technical and functional skills from AWS, SnowFlake, Informatica and others
  • 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
  • Your own career path within Sanofi. Your professional and personal development will be supported purposefully
  • Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue progress, discover extraordinary

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.

Budapest

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