Scientific Writer in Pre-Clinical Development- Romainville, FR

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden) and in the United States, Boston.

 

We’re in the business of changing lives.  In our quest to discover and develop life-improving medicines we go where no one has ever gone before.   In every challenge we face, we see new opportunities.  We want to challenge the impossible.  We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.  Collaborative innovators and perseverant idealists. We need the best-in-class.  In other words, we need you: The ‘make-it-happeners’. 

 

We are looking for a Scientific Writer in Pre-Clinical Development (based in France).

                       

Your role

You will support the development and writing of nonclinical sections of regulatory documents. You will provide to the preclinical teams a scientific and writing expertise, in order to deliver documents and electronic files timely, and at the right quality level, which meet all regulatory requirements


The ideal candidate has broad experience with the development and writing of different types of nonclinical section of key regulatory documents, all in the end contributing to successful conduct for a complete and concise submission dossier. The job requires:    

  • Writing activities (preclinical and regulatory documents)
  • Adequate planning of writing activities
  • Participation in project teams
  • Oversight of external writer(s), when a document is prepared by a CRO

Requirements

Who are you ?

  •  The successful candidate has at least an MSc degree in sciences, with at least 5 years of hands-on medical writing experience within the life-science / pharmaceutical industry
  • You are used to write documents like protocols, preclinical study reports, briefing books, investigator brochures, and other regulatory documents (response to questions from authorities, …).
  • Furthermore you have profound understanding and working knowledge with respect to the preparation of documents for submission for marketing approval.
  • You show proficiency with MS-Word and preferably with document management systems.
  • You should be able to organize and plan multiple priorities, and have the ability to coordinate and collaborate with the CROs.
  • You’re familiar with the new SEND process.
  • Last but not least, having excellent interpersonal and communication skills is required, together with being fluent in English (oral and in writing).

What’s in it for you ?

 

You will be part of a fast growing and amazing company.  As ‘make-it-happener’ you will get all the support you need to make your job successful.  At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen…!