SCIENTIFIC / MEDICAL WRITER

XPE Pharma is looking to hire a (m/f) Scientific / Medical Writer for one of its clients, a major Pharmaceutical Industry company situated near Brussels (Belgium).

GENERAL DESCRIPTION

The Scientific/Medical writer writes clinical and epidemiology documents (investigator brochure, protocols, ICFs, clinical reports, summary of clinical data, expert reports briefing documents, ...) to be included in registration files.
Furthermore, the writer ensures the consistency and quality level of all documents that are issued.

KEY RESPONSIBILITIES & ACCOUNTABILITIES

1. Writes clinical and epidemiology documents (investigator brochure, protocols, ICFs, clinical reports, summary of clinical data, expert reports briefing documents, ...) to be included in registration files

• Identify and anticipate information needs on scientific/clinical matters and business related issues
• Capture relevant data/information in order to satisfy clients' needs (CDM's - investigators - scientific/clinical community - authorities)
• Analyse, interpret and integrate all data captured in order to provide relevant documents for decision makers
• Writes publications (articles, abstracts, posters, presentations) derived from Clinical and EPI studies
• Participates in the definition of technical responses to be given to regulatory authorities.

2. Ensures the consistency and quality level of all documents that are issued

• Implement and monitor "Good Documentation Practices"
• Ensure the timely dissemination of relevant information and/or documents to each target audience.

 
REQUIRED EDUCATION & SKILLS

Education : Bachelors Degree in life science, biology, chemistry, biochemistry, pharmacology, PhD is a plus.

Knowledge:
• Excellent level of spoken & written English
• Knowledge of ICH, GCP and SOP standards is an asset
• Excellent communication and organizational skills
• Ability to deal with complex scientific issues
• Ability to work/participate in cross-functional teams
• Positive attitude
• Flexible (adapting to changes within a project, i.e changes of priorities, increase/decrease of workload)

Experience :
• Experience in clinical investigation/development, ICH, GCP and SOP standards, preferably related to Scientific/Medical Writing (or equivalent : PhD, academic research with experience in publications)
• Experience in multicultural settings, diverse environments with respect to dynamics of human interaction.