EMTEX is an independent and compact company that offers professional medical writing and related services all around the world to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions. We have a long track record in supporting our customers with dedicated services. As we would like to expand our international services, grow and strengthen our team, we have a job opening for a Junior Medical Writer.
Successful candidates will assist in the preparation 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
- Assist more experienced Medical Writers in the preparation of simple documents.
- Supported by a Senior or Specialist Medical Writer, write clear, concise, and consistent simple 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
- Model a rigorous and disciplined approach to medical writing
- Ensure that all work is complete and of high quality (and adhere to the instructions from the more experienced Medical Writer)
- 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
- Attend (or lead) internal and client team meetings as required
- Orchestrate an effective and efficient document review process
- 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.
Relevant experience will be considered an advantage. A pronounced passion for writing is key!
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
- Be pro-active
- 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.
Interested? Send your motivation letter and CV (attn. of Mrs. Griet Van Acker).