Experienced Medical Writer
Experienced Medical Writer
Hoogeindeken 8L Sint-Gillis-Waas Belgium
EMTEX is an independent and compact company that offers professional medical writing services all around the world to the biotechnology, pharmaceutical, food and medical device industry. We have a long track record in supporting our customers with dedicated services, increasing value by writing high quality documents within agreed deadlines. As we would like to expand our international services, grow and strengthen our team, we have a job opening for an Experienced Medical Writer.
Successful candidates will be responsible for the preparation and coordination of a wide range of clinical and regulatory documents, including Investigator Brochures, Clinical Study Reports, Clinical Trial Protocols, Clinical Summaries of Efficacy and Safety and Clinical Overviews. The documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and must adhere to regulatory guidelines and company styles and processes.
Full-time (40 hours per week); in office/home office.
Roles & responsibilities
Write clear, concise and consistent simple or complex documents compliant with the needs of the regulations or questions of the authorities, as appropriate.
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
Carry out novel or complex assignments with minimal assistance
Model a rigorous and disciplined approach to medical writing
Ensure that all work is complete and of high quality
Ensure document content and style adhere to FDA/EMA or other appropriate regulatory guidelines, and comply with internal and client SOPs/WIs and style guidelines
Orchestrate an effective and efficient document review process
Attend or lead internal and client team meetings as required
Perform peer review of draft documents prepared by other Medical Writers before external distribution when requested.
Initiate and participate in process improvement and training initiatives, and assist in the development of SOPs/WIs.
Assist with project management for a limited number of projects.
Act as primary client contact for a limited number of projects.
Perform Quality Control checks of documents.
A minimum of a Master's degree in a scientific discipline (a degree in biological, veterinary, pharmaceutical or medical sciences) is highly preferred.
3-5 years hands-on experience in Regulatory Medical Writing.
Skills & competences
Have/develop an eye for detail
Further improve spoken and written English
Demonstrate excellent computer skills
Be a good communicator
Have a team-oriented attitude
Act/behave professionally with a client focus
Always be eager to learn
Further improve your writing skills
Take ownership/responsibility of your document
Be well organized
Excellent written and verbal language skills in English and Dutch (C1 or better).
We offer a competitive salary package and company car.
Interested? Please send your application letter with an indication of your motivation and experience together with your CV to HRD@emtex.be (attn. of Mr. Mario De Witte).