We are actively looking for an experienced Medical writer for our partner, a dynamic fast growing Biotech company with several offices in Europe and one in Belgium (Mechelen)
“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’”
Scope of the job
The ideal candidate has broad experience with the development and writing of different types of key clinical and regulatory documents, all in the end contributing to successful conduct and reporting of clinical study results for a complete and concise submission dossier.
The job requires:
• Writing activities (clinical and regulatory documents)
• Adequate planning of writing activities
• Participation in project- and study-teams
• Oversight of external medical writer(s), when a document is outsourced
You will support the development and writing of clinical and regulatory documents. You will provide to the clinical team scientific and writing expertise, in order deliver timely documents that meet all quality and regulatory requirements.
Who are you ?
• The successful candidate has at least a MSc degree in sciences, with at least 3 years of hands-on medical writing experience within the life-science / pharmaceutical industry. Experience in writing pre-clinical text and/or pharmacokinetic/pharmacodynamics sections.
• You are used to write documents like protocols, clinical study reports, briefing books, investigator brochures, and other regulatory documents (response to questions from authorities, pediatric investigation plan, …).
• 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 External Service Providers.
• Last but not least, having excellent interpersonal and communication skills is required, together with being fluent in English (oral and in writing).
You will be part of a fast growing and amazing company, a highly motivated team. You will get all the support you need to make your job successful.
We offer you a competitive remuneration package and a dynamic work environment.
How to apply?
IF YOU HAVE the right skills, don’t wait and send me your CV and your best cover letter!