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Experienced Medical Writer

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.

Job description

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.

Job type

Full-time (40 hours per week); in office/home office.

Primary location

Sint-Gillis-Waas

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.

Education

A minimum of a Master's degree in a scientific discipline (a degree in biological, veterinary, pharmaceutical or medical sciences) is highly preferred.

Experience

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
  • Be pro-active
  • Always be eager to learn
  • Further improve your writing skills
  • Take ownership/responsibility of your document
  • Be well organized

Language

Excellent written and verbal language skills in English and Dutch (C1 or better).

Our offer

We offer a competitive salary package and company car.

Contact information

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).

EMTEX BV
Hoogeindeken 8L
9170 Sint-Gillis-Waas

The only way to do great work, is to love what you do.

Steve Jobs